Trial Outcomes & Findings for Study of Combination Therapy With INCMGA00012 (Anti-PD-1), INCAGN02385 (Anti-LAG-3), and INCAGN02390 (Anti-TIM-3) in Participants With Select Advanced Malignancies (NCT NCT04370704)
NCT ID: NCT04370704
Last Updated: 2026-08-17
Results Overview
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE was defined as an AE either reported for the first time or the worsening of a pre-existing event, after the first dose of study drug until 90 days after the last dose of study drug.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
61 participants
Primary outcome timeframe
up to 1148 days
Results posted on
2026-08-17
Participant Flow
This study was conducted at 5 study centers in the United States.
Participant milestones
| Measure |
Phase 1, Part 1: Tuparstobart 350 mg Q2W + Verzistobart 400 mg Q2W
Participants with locally advanced (not amendable to resection with curative intent) or metastatic solid tumors that have failed available therapies (including anti-programmed cell death protein 1/programmed cell death ligand 1 \[PD-1/PD-L1\] therapy) or who are intolerant to, or ineligible for, standard treatment received tuparstobart 350 mg once every 2 weeks (Q2W) and verzistobart 400 mg Q2W as separate consecutive intravenous infusions.
|
Phase 1, Part 2: Tuparstobart 350 mg Q2W + Verzistobart 400 mg Q2W + Retifanlimab 500 mg Q4W
Participants with locally advanced (not amendable to resection with curative intent) or metastatic solid tumors that have failed available therapies (including anti-PD-1/PD-L1 therapy) or who are intolerant to, or ineligible for, standard treatment received tuparstobart 350 mg Q2W, verzistobart 400 mg Q2W, and retifanlimab 500 mg once every 4 weeks (Q4W) as separate consecutive intravenous infusions.
|
Phase 1, Part 3: Tuparstobart 450 mg Q3W; Tuparstobart 450 mg Q3W + Retifanlimab 375 mg Q3W
Participants with locally advanced (not amendable to resection with curative intent) or metastatic solid tumors that have failed available therapies (including anti-PD-1/PD-L1 therapy) or who are intolerant to, or ineligible for, standard treatment received tuparstobart 450 mg intravenously once every 3 weeks (Q3W) as monotherapy in two 21-day cycles. Participants then received tuparstobart 450 mg Q3W and retifanlimab 375 mg Q3W as separate consecutive intravenous infusions.
|
Phase 1, Part 3: Tuparstobart 750 mg Q3W; Tuparstobart 750 mg Q3W + Retifanlimab 375 mg Q3W
Participants with locally advanced (not amendable to resection with curative intent) or metastatic solid tumors who have failed available therapies (including anti-PD-1/PD-L1 therapy) or who are intolerant to, or ineligible for, standard treatment received tuparstobart 750 mg intravenously Q3W as monotherapy in two 21-day cycles. Participants then received tuparstobart 750 mg Q3W and retifanlimab 375 mg Q3W as separate consecutive intravenous infusions.
|
Phase 1, Part 3: Verzistobart 500 mg Q3W; Verzistobart 500 mg Q3W + Retifanlimab 375 mg Q3W
Participants with locally advanced (not amendable to resection with curative intent) or metastatic solid tumors who have failed available therapies (including anti-PD-1/PD-L1 therapy) or who are intolerant to, or ineligible for, standard treatment received verzistobart 500 mg intravenously Q3W as monotherapy in two 21-day cycles. Participants then received verzistobart 500 mg Q3W and retifanlimab 375 mg Q3W as separate consecutive intravenous infusions.
|
Phase 1, Part 3: Verzistobart 1000 mg Q3W; Verzistobart 1000 mg Q3W + Retifanlimab 375 mg Q3W
Participants with locally advanced (not amendable to resection with curative intent) or metastatic solid tumors who have failed available therapies (including anti-PD-1/PD-L1 therapy) or who are intolerant to, or ineligible for, standard treatment received verzistobart 1000 mg intravenously Q3W as monotherapy in two 21-day cycles. Participants then received verzistobart 1000 mg Q3W and retifanlimab 375 mg Q3W as separate consecutive intravenous infusions.
|
Phase 2, Cohort A: Tuparstobart 350 mg Q2W + Verzistobart 400 mg Q2W + Retifanlimab 500 mg Q4W
Participants with histologically confirmed unresectable/metastatic melanoma whose disease failed prior anti-PD-1/PD-L1 therapy (alone or as part of a combination) and who met protocol-defined criteria received tuparstobart 350 mg Q2W, verzistobart 400 mg Q2W, and retifanlimab 500 mg Q4W as separate consecutive intravenous infusions.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
11
|
6
|
6
|
6
|
6
|
16
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
10
|
11
|
6
|
6
|
6
|
6
|
16
|
Reasons for withdrawal
| Measure |
Phase 1, Part 1: Tuparstobart 350 mg Q2W + Verzistobart 400 mg Q2W
Participants with locally advanced (not amendable to resection with curative intent) or metastatic solid tumors that have failed available therapies (including anti-programmed cell death protein 1/programmed cell death ligand 1 \[PD-1/PD-L1\] therapy) or who are intolerant to, or ineligible for, standard treatment received tuparstobart 350 mg once every 2 weeks (Q2W) and verzistobart 400 mg Q2W as separate consecutive intravenous infusions.
|
Phase 1, Part 2: Tuparstobart 350 mg Q2W + Verzistobart 400 mg Q2W + Retifanlimab 500 mg Q4W
Participants with locally advanced (not amendable to resection with curative intent) or metastatic solid tumors that have failed available therapies (including anti-PD-1/PD-L1 therapy) or who are intolerant to, or ineligible for, standard treatment received tuparstobart 350 mg Q2W, verzistobart 400 mg Q2W, and retifanlimab 500 mg once every 4 weeks (Q4W) as separate consecutive intravenous infusions.
|
Phase 1, Part 3: Tuparstobart 450 mg Q3W; Tuparstobart 450 mg Q3W + Retifanlimab 375 mg Q3W
Participants with locally advanced (not amendable to resection with curative intent) or metastatic solid tumors that have failed available therapies (including anti-PD-1/PD-L1 therapy) or who are intolerant to, or ineligible for, standard treatment received tuparstobart 450 mg intravenously once every 3 weeks (Q3W) as monotherapy in two 21-day cycles. Participants then received tuparstobart 450 mg Q3W and retifanlimab 375 mg Q3W as separate consecutive intravenous infusions.
|
Phase 1, Part 3: Tuparstobart 750 mg Q3W; Tuparstobart 750 mg Q3W + Retifanlimab 375 mg Q3W
Participants with locally advanced (not amendable to resection with curative intent) or metastatic solid tumors who have failed available therapies (including anti-PD-1/PD-L1 therapy) or who are intolerant to, or ineligible for, standard treatment received tuparstobart 750 mg intravenously Q3W as monotherapy in two 21-day cycles. Participants then received tuparstobart 750 mg Q3W and retifanlimab 375 mg Q3W as separate consecutive intravenous infusions.
|
Phase 1, Part 3: Verzistobart 500 mg Q3W; Verzistobart 500 mg Q3W + Retifanlimab 375 mg Q3W
Participants with locally advanced (not amendable to resection with curative intent) or metastatic solid tumors who have failed available therapies (including anti-PD-1/PD-L1 therapy) or who are intolerant to, or ineligible for, standard treatment received verzistobart 500 mg intravenously Q3W as monotherapy in two 21-day cycles. Participants then received verzistobart 500 mg Q3W and retifanlimab 375 mg Q3W as separate consecutive intravenous infusions.
|
Phase 1, Part 3: Verzistobart 1000 mg Q3W; Verzistobart 1000 mg Q3W + Retifanlimab 375 mg Q3W
Participants with locally advanced (not amendable to resection with curative intent) or metastatic solid tumors who have failed available therapies (including anti-PD-1/PD-L1 therapy) or who are intolerant to, or ineligible for, standard treatment received verzistobart 1000 mg intravenously Q3W as monotherapy in two 21-day cycles. Participants then received verzistobart 1000 mg Q3W and retifanlimab 375 mg Q3W as separate consecutive intravenous infusions.
|
Phase 2, Cohort A: Tuparstobart 350 mg Q2W + Verzistobart 400 mg Q2W + Retifanlimab 500 mg Q4W
Participants with histologically confirmed unresectable/metastatic melanoma whose disease failed prior anti-PD-1/PD-L1 therapy (alone or as part of a combination) and who met protocol-defined criteria received tuparstobart 350 mg Q2W, verzistobart 400 mg Q2W, and retifanlimab 500 mg Q4W as separate consecutive intravenous infusions.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Captured as "Other" in Database
|
0
|
0
|
3
|
1
|
0
|
0
|
3
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
1
|
2
|
2
|
3
|
|
Overall Study
Sponsor Decision
|
0
|
1
|
1
|
3
|
1
|
1
|
4
|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
0
|
0
|
0
|
1
|
1
|
|
Overall Study
Death
|
9
|
8
|
2
|
1
|
3
|
2
|
4
|
Baseline Characteristics
Study of Combination Therapy With INCMGA00012 (Anti-PD-1), INCAGN02385 (Anti-LAG-3), and INCAGN02390 (Anti-TIM-3) in Participants With Select Advanced Malignancies
Baseline characteristics by cohort
| Measure |
Phase 1, Part 1: Tuparstobart 350 mg Q2W + Verzistobart 400 mg Q2W
n=10 Participants
Participants with locally advanced (not amendable to resection with curative intent) or metastatic solid tumors that have failed available therapies (including anti-programmed cell death protein 1/programmed cell death ligand 1 \[PD-1/PD-L1\] therapy) or who are intolerant to, or ineligible for, standard treatment received tuparstobart 350 mg once every 2 weeks (Q2W) and verzistobart 400 mg Q2W as separate consecutive intravenous infusions.
|
Phase 1, Part 2: Tuparstobart 350 mg Q2W + Verzistobart 400 mg Q2W + Retifanlimab 500 mg Q4W
n=11 Participants
Participants with locally advanced (not amendable to resection with curative intent) or metastatic solid tumors that have failed available therapies (including anti-PD-1/PD-L1 therapy) or who are intolerant to, or ineligible for, standard treatment received tuparstobart 350 mg Q2W, verzistobart 400 mg Q2W, and retifanlimab 500 mg once every 4 weeks (Q4W) as separate consecutive intravenous infusions.
|
Phase 1, Part 3: Tuparstobart 450 mg Q3W; Tuparstobart 450 mg Q3W + Retifanlimab 375 mg Q3W
n=6 Participants
Participants with locally advanced (not amendable to resection with curative intent) or metastatic solid tumors that have failed available therapies (including anti-PD-1/PD-L1 therapy) or who are intolerant to, or ineligible for, standard treatment received tuparstobart 450 mg intravenously once every 3 weeks (Q3W) as monotherapy in two 21-day cycles. Participants then received tuparstobart 450 mg Q3W and retifanlimab 375 mg Q3W as separate consecutive intravenous infusions.
|
Phase 1, Part 3: Tuparstobart 750 mg Q3W; Tuparstobart 750 mg Q3W + Retifanlimab 375 mg Q3W
n=6 Participants
Participants with locally advanced (not amendable to resection with curative intent) or metastatic solid tumors who have failed available therapies (including anti-PD-1/PD-L1 therapy) or who are intolerant to, or ineligible for, standard treatment received tuparstobart 750 mg intravenously Q3W as monotherapy in two 21-day cycles. Participants then received tuparstobart 750 mg Q3W and retifanlimab 375 mg Q3W as separate consecutive intravenous infusions.
|
Phase 1, Part 3: Verzistobart 500 mg Q3W; Verzistobart 500 mg Q3W + Retifanlimab 375 mg Q3W
n=6 Participants
Participants with locally advanced (not amendable to resection with curative intent) or metastatic solid tumors who have failed available therapies (including anti-PD-1/PD-L1 therapy) or who are intolerant to, or ineligible for, standard treatment received verzistobart 500 mg intravenously Q3W as monotherapy in two 21-day cycles. Participants then received verzistobart 500 mg Q3W and retifanlimab 375 mg Q3W as separate consecutive intravenous infusions.
|
Phase 1, Part 3: Verzistobart 1000 mg Q3W; Verzistobart 1000 mg Q3W + Retifanlimab 375 mg Q3W
n=6 Participants
Participants with locally advanced (not amendable to resection with curative intent) or metastatic solid tumors who have failed available therapies (including anti-PD-1/PD-L1 therapy) or who are intolerant to, or ineligible for, standard treatment received verzistobart 1000 mg intravenously Q3W as monotherapy in two 21-day cycles. Participants then received verzistobart 1000 mg Q3W and retifanlimab 375 mg Q3W as separate consecutive intravenous infusions.
|
Phase 2, Cohort A: Tuparstobart 350 mg Q2W + Verzistobart 400 mg Q2W + Retifanlimab 500 mg Q4W
n=16 Participants
Participants with histologically confirmed unresectable/metastatic melanoma whose disease failed prior anti-PD-1/PD-L1 therapy (alone or as part of a combination) and who met protocol-defined criteria received tuparstobart 350 mg Q2W, verzistobart 400 mg Q2W, and retifanlimab 500 mg Q4W as separate consecutive intravenous infusions.
|
Total
n=61 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
60.7 years
STANDARD_DEVIATION 18.23 • n=51 Participants
|
54.2 years
STANDARD_DEVIATION 13.37 • n=51 Participants
|
55.2 years
STANDARD_DEVIATION 13.18 • n=102 Participants
|
59.7 years
STANDARD_DEVIATION 14.56 • n=18 Participants
|
45.3 years
STANDARD_DEVIATION 15.29 • n=74 Participants
|
60.7 years
STANDARD_DEVIATION 16.03 • n=24 Participants
|
66.0 years
STANDARD_DEVIATION 10.33 • n=23 Participants
|
58.75 years
STANDARD_DEVIATION 14.63 • n=28 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=51 Participants
|
7 Participants
n=51 Participants
|
2 Participants
n=102 Participants
|
4 Participants
n=18 Participants
|
3 Participants
n=74 Participants
|
3 Participants
n=24 Participants
|
9 Participants
n=23 Participants
|
34 Participants
n=28 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=51 Participants
|
4 Participants
n=51 Participants
|
4 Participants
n=102 Participants
|
2 Participants
n=18 Participants
|
3 Participants
n=74 Participants
|
3 Participants
n=24 Participants
|
7 Participants
n=23 Participants
|
27 Participants
n=28 Participants
|
|
Race/Ethnicity, Customized
White/Caucasian
|
7 Participants
n=51 Participants
|
11 Participants
n=51 Participants
|
4 Participants
n=102 Participants
|
4 Participants
n=18 Participants
|
6 Participants
n=74 Participants
|
5 Participants
n=24 Participants
|
12 Participants
n=23 Participants
|
49 Participants
n=28 Participants
|
|
Race/Ethnicity, Customized
Black/African-American
|
1 Participants
n=51 Participants
|
0 Participants
n=51 Participants
|
1 Participants
n=102 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=74 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=23 Participants
|
3 Participants
n=28 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=51 Participants
|
0 Participants
n=51 Participants
|
1 Participants
n=102 Participants
|
1 Participants
n=18 Participants
|
0 Participants
n=74 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=23 Participants
|
4 Participants
n=28 Participants
|
|
Race/Ethnicity, Customized
Unspecified
|
1 Participants
n=51 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=102 Participants
|
1 Participants
n=18 Participants
|
0 Participants
n=74 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=23 Participants
|
2 Participants
n=28 Participants
|
|
Race/Ethnicity, Customized
Captured as "Hispanic" in Database
|
0 Participants
n=51 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=74 Participants
|
0 Participants
n=24 Participants
|
3 Participants
n=23 Participants
|
3 Participants
n=28 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
0 Participants
n=51 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=18 Participants
|
2 Participants
n=74 Participants
|
0 Participants
n=24 Participants
|
4 Participants
n=23 Participants
|
6 Participants
n=28 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
9 Participants
n=51 Participants
|
11 Participants
n=51 Participants
|
3 Participants
n=102 Participants
|
5 Participants
n=18 Participants
|
4 Participants
n=74 Participants
|
5 Participants
n=24 Participants
|
12 Participants
n=23 Participants
|
49 Participants
n=28 Participants
|
|
Race/Ethnicity, Customized
Captured as "Other" in Database
|
1 Participants
n=51 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=102 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=74 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=23 Participants
|
1 Participants
n=28 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
0 Participants
n=51 Participants
|
0 Participants
n=51 Participants
|
3 Participants
n=102 Participants
|
1 Participants
n=18 Participants
|
0 Participants
n=74 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=23 Participants
|
5 Participants
n=28 Participants
|
PRIMARY outcome
Timeframe: up to 1148 daysPopulation: Full Analysis Set: all participants enrolled in the study who received at least 1 dose of assigned study treatment
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE was defined as an AE either reported for the first time or the worsening of a pre-existing event, after the first dose of study drug until 90 days after the last dose of study drug.
Outcome measures
| Measure |
Phase 1, Part 1: Tuparstobart 350 mg Q2W + Verzistobart 400 mg Q2W
n=10 Participants
Participants with locally advanced (not amendable to resection with curative intent) or metastatic solid tumors that have failed available therapies (including anti-programmed cell death protein 1/programmed cell death ligand 1 \[PD-1/PD-L1\] therapy) or who are intolerant to, or ineligible for, standard treatment received tuparstobart 350 mg once every 2 weeks (Q2W) and verzistobart 400 mg Q2W as separate consecutive intravenous infusions.
|
Phase 1, Part 2: Tuparstobart 350 mg Q2W + Verzistobart 400 mg Q2W + Retifanlimab 500 mg Q4W
n=11 Participants
Participants with locally advanced (not amendable to resection with curative intent) or metastatic solid tumors that have failed available therapies (including anti-PD-1/PD-L1 therapy) or who are intolerant to, or ineligible for, standard treatment received tuparstobart 350 mg Q2W, verzistobart 400 mg Q2W, and retifanlimab 500 mg once every 4 weeks (Q4W) as separate consecutive intravenous infusions.
|
Phase 1, Part 3: Tuparstobart 450 mg Q3W; Tuparstobart 450 mg Q3W + Retifanlimab 375 mg Q3W
n=6 Participants
Participants with locally advanced (not amendable to resection with curative intent) or metastatic solid tumors that have failed available therapies (including anti-PD-1/PD-L1 therapy) or who are intolerant to, or ineligible for, standard treatment received tuparstobart 450 mg intravenously once every 3 weeks (Q3W) as monotherapy in two 21-day cycles. Participants then received tuparstobart 450 mg Q3W and retifanlimab 375 mg Q3W as separate consecutive intravenous infusions.
|
Phase 1, Part 3: Tuparstobart 750 mg Q3W; Tuparstobart 750 mg Q3W + Retifanlimab 375 mg Q3W
n=6 Participants
Participants with locally advanced (not amendable to resection with curative intent) or metastatic solid tumors who have failed available therapies (including anti-PD-1/PD-L1 therapy) or who are intolerant to, or ineligible for, standard treatment received tuparstobart 750 mg intravenously Q3W as monotherapy in two 21-day cycles. Participants then received tuparstobart 750 mg Q3W and retifanlimab 375 mg Q3W as separate consecutive intravenous infusions.
|
Phase 1, Part 3: Verzistobart 500 mg Q3W; Verzistobart 500 mg Q3W + Retifanlimab 375 mg Q3W
n=6 Participants
Participants with locally advanced (not amendable to resection with curative intent) or metastatic solid tumors who have failed available therapies (including anti-PD-1/PD-L1 therapy) or who are intolerant to, or ineligible for, standard treatment received verzistobart 500 mg intravenously Q3W as monotherapy in two 21-day cycles. Participants then received verzistobart 500 mg Q3W and retifanlimab 375 mg Q3W as separate consecutive intravenous infusions.
|
Phase 1, Part 3: Verzistobart 1000 mg Q3W; Verzistobart 1000 mg Q3W + Retifanlimab 375 mg Q3W
n=6 Participants
Participants with locally advanced (not amendable to resection with curative intent) or metastatic solid tumors who have failed available therapies (including anti-PD-1/PD-L1 therapy) or who are intolerant to, or ineligible for, standard treatment received verzistobart 1000 mg intravenously Q3W as monotherapy in two 21-day cycles. Participants then received verzistobart 1000 mg Q3W and retifanlimab 375 mg Q3W as separate consecutive intravenous infusions.
|
|---|---|---|---|---|---|---|
|
Phase 1: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
|
8 Participants
|
11 Participants
|
6 Participants
|
5 Participants
|
6 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: up to 1148 daysPopulation: Full Analysis Set
The severity of AEs was assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 Grades 1 through 5. Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment not indicated. Grade 2: moderate; minimal, local, or noninvasive treatment indicated; limiting age-appropriate activities of daily living. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent treatment indicated. Grade 5: fatal. An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A TEAE was defined as an AE reported either reported for the first time or the worsening of a pre-existing event, after the first dose of study drug until 90 days after the last dose of study drug.
Outcome measures
| Measure |
Phase 1, Part 1: Tuparstobart 350 mg Q2W + Verzistobart 400 mg Q2W
n=10 Participants
Participants with locally advanced (not amendable to resection with curative intent) or metastatic solid tumors that have failed available therapies (including anti-programmed cell death protein 1/programmed cell death ligand 1 \[PD-1/PD-L1\] therapy) or who are intolerant to, or ineligible for, standard treatment received tuparstobart 350 mg once every 2 weeks (Q2W) and verzistobart 400 mg Q2W as separate consecutive intravenous infusions.
|
Phase 1, Part 2: Tuparstobart 350 mg Q2W + Verzistobart 400 mg Q2W + Retifanlimab 500 mg Q4W
n=11 Participants
Participants with locally advanced (not amendable to resection with curative intent) or metastatic solid tumors that have failed available therapies (including anti-PD-1/PD-L1 therapy) or who are intolerant to, or ineligible for, standard treatment received tuparstobart 350 mg Q2W, verzistobart 400 mg Q2W, and retifanlimab 500 mg once every 4 weeks (Q4W) as separate consecutive intravenous infusions.
|
Phase 1, Part 3: Tuparstobart 450 mg Q3W; Tuparstobart 450 mg Q3W + Retifanlimab 375 mg Q3W
n=6 Participants
Participants with locally advanced (not amendable to resection with curative intent) or metastatic solid tumors that have failed available therapies (including anti-PD-1/PD-L1 therapy) or who are intolerant to, or ineligible for, standard treatment received tuparstobart 450 mg intravenously once every 3 weeks (Q3W) as monotherapy in two 21-day cycles. Participants then received tuparstobart 450 mg Q3W and retifanlimab 375 mg Q3W as separate consecutive intravenous infusions.
|
Phase 1, Part 3: Tuparstobart 750 mg Q3W; Tuparstobart 750 mg Q3W + Retifanlimab 375 mg Q3W
n=6 Participants
Participants with locally advanced (not amendable to resection with curative intent) or metastatic solid tumors who have failed available therapies (including anti-PD-1/PD-L1 therapy) or who are intolerant to, or ineligible for, standard treatment received tuparstobart 750 mg intravenously Q3W as monotherapy in two 21-day cycles. Participants then received tuparstobart 750 mg Q3W and retifanlimab 375 mg Q3W as separate consecutive intravenous infusions.
|
Phase 1, Part 3: Verzistobart 500 mg Q3W; Verzistobart 500 mg Q3W + Retifanlimab 375 mg Q3W
n=6 Participants
Participants with locally advanced (not amendable to resection with curative intent) or metastatic solid tumors who have failed available therapies (including anti-PD-1/PD-L1 therapy) or who are intolerant to, or ineligible for, standard treatment received verzistobart 500 mg intravenously Q3W as monotherapy in two 21-day cycles. Participants then received verzistobart 500 mg Q3W and retifanlimab 375 mg Q3W as separate consecutive intravenous infusions.
|
Phase 1, Part 3: Verzistobart 1000 mg Q3W; Verzistobart 1000 mg Q3W + Retifanlimab 375 mg Q3W
n=6 Participants
Participants with locally advanced (not amendable to resection with curative intent) or metastatic solid tumors who have failed available therapies (including anti-PD-1/PD-L1 therapy) or who are intolerant to, or ineligible for, standard treatment received verzistobart 1000 mg intravenously Q3W as monotherapy in two 21-day cycles. Participants then received verzistobart 1000 mg Q3W and retifanlimab 375 mg Q3W as separate consecutive intravenous infusions.
|
|---|---|---|---|---|---|---|
|
Phase 1: Number of Participants With Any ≥Grade 3 TEAE
|
5 Participants
|
6 Participants
|
3 Participants
|
4 Participants
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: up to 325 daysPopulation: RECIST Evaluable Analysis Set: all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met at least 1 of the following criteria: (1) had ≥1 postbaseline scan; (2) had been on the study for a minimum of 56 days of follow-up; (3) had discontinued from treatment. The confidence interval was calculated based on the exact method for binomial distributions.
ORR was defined as the percentage of participants with a complete response (CR) or partial response (PR), as determined by investigator assessment of radiographic disease assessments per Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1 (v1.1).
Outcome measures
| Measure |
Phase 1, Part 1: Tuparstobart 350 mg Q2W + Verzistobart 400 mg Q2W
n=16 Participants
Participants with locally advanced (not amendable to resection with curative intent) or metastatic solid tumors that have failed available therapies (including anti-programmed cell death protein 1/programmed cell death ligand 1 \[PD-1/PD-L1\] therapy) or who are intolerant to, or ineligible for, standard treatment received tuparstobart 350 mg once every 2 weeks (Q2W) and verzistobart 400 mg Q2W as separate consecutive intravenous infusions.
|
Phase 1, Part 2: Tuparstobart 350 mg Q2W + Verzistobart 400 mg Q2W + Retifanlimab 500 mg Q4W
Participants with locally advanced (not amendable to resection with curative intent) or metastatic solid tumors that have failed available therapies (including anti-PD-1/PD-L1 therapy) or who are intolerant to, or ineligible for, standard treatment received tuparstobart 350 mg Q2W, verzistobart 400 mg Q2W, and retifanlimab 500 mg once every 4 weeks (Q4W) as separate consecutive intravenous infusions.
|
Phase 1, Part 3: Tuparstobart 450 mg Q3W; Tuparstobart 450 mg Q3W + Retifanlimab 375 mg Q3W
Participants with locally advanced (not amendable to resection with curative intent) or metastatic solid tumors that have failed available therapies (including anti-PD-1/PD-L1 therapy) or who are intolerant to, or ineligible for, standard treatment received tuparstobart 450 mg intravenously once every 3 weeks (Q3W) as monotherapy in two 21-day cycles. Participants then received tuparstobart 450 mg Q3W and retifanlimab 375 mg Q3W as separate consecutive intravenous infusions.
|
Phase 1, Part 3: Tuparstobart 750 mg Q3W; Tuparstobart 750 mg Q3W + Retifanlimab 375 mg Q3W
Participants with locally advanced (not amendable to resection with curative intent) or metastatic solid tumors who have failed available therapies (including anti-PD-1/PD-L1 therapy) or who are intolerant to, or ineligible for, standard treatment received tuparstobart 750 mg intravenously Q3W as monotherapy in two 21-day cycles. Participants then received tuparstobart 750 mg Q3W and retifanlimab 375 mg Q3W as separate consecutive intravenous infusions.
|
Phase 1, Part 3: Verzistobart 500 mg Q3W; Verzistobart 500 mg Q3W + Retifanlimab 375 mg Q3W
Participants with locally advanced (not amendable to resection with curative intent) or metastatic solid tumors who have failed available therapies (including anti-PD-1/PD-L1 therapy) or who are intolerant to, or ineligible for, standard treatment received verzistobart 500 mg intravenously Q3W as monotherapy in two 21-day cycles. Participants then received verzistobart 500 mg Q3W and retifanlimab 375 mg Q3W as separate consecutive intravenous infusions.
|
Phase 1, Part 3: Verzistobart 1000 mg Q3W; Verzistobart 1000 mg Q3W + Retifanlimab 375 mg Q3W
Participants with locally advanced (not amendable to resection with curative intent) or metastatic solid tumors who have failed available therapies (including anti-PD-1/PD-L1 therapy) or who are intolerant to, or ineligible for, standard treatment received verzistobart 1000 mg intravenously Q3W as monotherapy in two 21-day cycles. Participants then received verzistobart 1000 mg Q3W and retifanlimab 375 mg Q3W as separate consecutive intravenous infusions.
|
|---|---|---|---|---|---|---|
|
Phase 2: Objective Response Rate (ORR)
|
6.3 percentage of participants
Interval 0.2 to 30.2
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: up to 325 daysPopulation: RECIST Evaluable Analysis Set. Only participants with CR or PR were analyzed.
DOR was defined as the time from the earliest date of disease response (CR or PR) until the earliest date of disease progression, as determined by investigator assessment of radiographic disease per RECIST v1.1, or death from any cause, if it occurred sooner than progression.
Outcome measures
| Measure |
Phase 1, Part 1: Tuparstobart 350 mg Q2W + Verzistobart 400 mg Q2W
n=1 Participants
Participants with locally advanced (not amendable to resection with curative intent) or metastatic solid tumors that have failed available therapies (including anti-programmed cell death protein 1/programmed cell death ligand 1 \[PD-1/PD-L1\] therapy) or who are intolerant to, or ineligible for, standard treatment received tuparstobart 350 mg once every 2 weeks (Q2W) and verzistobart 400 mg Q2W as separate consecutive intravenous infusions.
|
Phase 1, Part 2: Tuparstobart 350 mg Q2W + Verzistobart 400 mg Q2W + Retifanlimab 500 mg Q4W
Participants with locally advanced (not amendable to resection with curative intent) or metastatic solid tumors that have failed available therapies (including anti-PD-1/PD-L1 therapy) or who are intolerant to, or ineligible for, standard treatment received tuparstobart 350 mg Q2W, verzistobart 400 mg Q2W, and retifanlimab 500 mg once every 4 weeks (Q4W) as separate consecutive intravenous infusions.
|
Phase 1, Part 3: Tuparstobart 450 mg Q3W; Tuparstobart 450 mg Q3W + Retifanlimab 375 mg Q3W
Participants with locally advanced (not amendable to resection with curative intent) or metastatic solid tumors that have failed available therapies (including anti-PD-1/PD-L1 therapy) or who are intolerant to, or ineligible for, standard treatment received tuparstobart 450 mg intravenously once every 3 weeks (Q3W) as monotherapy in two 21-day cycles. Participants then received tuparstobart 450 mg Q3W and retifanlimab 375 mg Q3W as separate consecutive intravenous infusions.
|
Phase 1, Part 3: Tuparstobart 750 mg Q3W; Tuparstobart 750 mg Q3W + Retifanlimab 375 mg Q3W
Participants with locally advanced (not amendable to resection with curative intent) or metastatic solid tumors who have failed available therapies (including anti-PD-1/PD-L1 therapy) or who are intolerant to, or ineligible for, standard treatment received tuparstobart 750 mg intravenously Q3W as monotherapy in two 21-day cycles. Participants then received tuparstobart 750 mg Q3W and retifanlimab 375 mg Q3W as separate consecutive intravenous infusions.
|
Phase 1, Part 3: Verzistobart 500 mg Q3W; Verzistobart 500 mg Q3W + Retifanlimab 375 mg Q3W
Participants with locally advanced (not amendable to resection with curative intent) or metastatic solid tumors who have failed available therapies (including anti-PD-1/PD-L1 therapy) or who are intolerant to, or ineligible for, standard treatment received verzistobart 500 mg intravenously Q3W as monotherapy in two 21-day cycles. Participants then received verzistobart 500 mg Q3W and retifanlimab 375 mg Q3W as separate consecutive intravenous infusions.
|
Phase 1, Part 3: Verzistobart 1000 mg Q3W; Verzistobart 1000 mg Q3W + Retifanlimab 375 mg Q3W
Participants with locally advanced (not amendable to resection with curative intent) or metastatic solid tumors who have failed available therapies (including anti-PD-1/PD-L1 therapy) or who are intolerant to, or ineligible for, standard treatment received verzistobart 1000 mg intravenously Q3W as monotherapy in two 21-day cycles. Participants then received verzistobart 1000 mg Q3W and retifanlimab 375 mg Q3W as separate consecutive intravenous infusions.
|
|---|---|---|---|---|---|---|
|
Phase 2: Duration of Response (DOR)
|
NA days
The median and the upper and lower limits of the confidence interval were not estimable because there was an insufficient number of participants with disease response (CR and PR).
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: up to 325 days beyond Day 56Population: RECIST Evaluable Analysis Set. The confidence interval was calculated based on the exact method for binomial distributions.
DCR was defined as the percentage of participants with CR, PR, or stable disease (SD) as best on-study response on or after Day 56.
Outcome measures
| Measure |
Phase 1, Part 1: Tuparstobart 350 mg Q2W + Verzistobart 400 mg Q2W
n=16 Participants
Participants with locally advanced (not amendable to resection with curative intent) or metastatic solid tumors that have failed available therapies (including anti-programmed cell death protein 1/programmed cell death ligand 1 \[PD-1/PD-L1\] therapy) or who are intolerant to, or ineligible for, standard treatment received tuparstobart 350 mg once every 2 weeks (Q2W) and verzistobart 400 mg Q2W as separate consecutive intravenous infusions.
|
Phase 1, Part 2: Tuparstobart 350 mg Q2W + Verzistobart 400 mg Q2W + Retifanlimab 500 mg Q4W
Participants with locally advanced (not amendable to resection with curative intent) or metastatic solid tumors that have failed available therapies (including anti-PD-1/PD-L1 therapy) or who are intolerant to, or ineligible for, standard treatment received tuparstobart 350 mg Q2W, verzistobart 400 mg Q2W, and retifanlimab 500 mg once every 4 weeks (Q4W) as separate consecutive intravenous infusions.
|
Phase 1, Part 3: Tuparstobart 450 mg Q3W; Tuparstobart 450 mg Q3W + Retifanlimab 375 mg Q3W
Participants with locally advanced (not amendable to resection with curative intent) or metastatic solid tumors that have failed available therapies (including anti-PD-1/PD-L1 therapy) or who are intolerant to, or ineligible for, standard treatment received tuparstobart 450 mg intravenously once every 3 weeks (Q3W) as monotherapy in two 21-day cycles. Participants then received tuparstobart 450 mg Q3W and retifanlimab 375 mg Q3W as separate consecutive intravenous infusions.
|
Phase 1, Part 3: Tuparstobart 750 mg Q3W; Tuparstobart 750 mg Q3W + Retifanlimab 375 mg Q3W
Participants with locally advanced (not amendable to resection with curative intent) or metastatic solid tumors who have failed available therapies (including anti-PD-1/PD-L1 therapy) or who are intolerant to, or ineligible for, standard treatment received tuparstobart 750 mg intravenously Q3W as monotherapy in two 21-day cycles. Participants then received tuparstobart 750 mg Q3W and retifanlimab 375 mg Q3W as separate consecutive intravenous infusions.
|
Phase 1, Part 3: Verzistobart 500 mg Q3W; Verzistobart 500 mg Q3W + Retifanlimab 375 mg Q3W
Participants with locally advanced (not amendable to resection with curative intent) or metastatic solid tumors who have failed available therapies (including anti-PD-1/PD-L1 therapy) or who are intolerant to, or ineligible for, standard treatment received verzistobart 500 mg intravenously Q3W as monotherapy in two 21-day cycles. Participants then received verzistobart 500 mg Q3W and retifanlimab 375 mg Q3W as separate consecutive intravenous infusions.
|
Phase 1, Part 3: Verzistobart 1000 mg Q3W; Verzistobart 1000 mg Q3W + Retifanlimab 375 mg Q3W
Participants with locally advanced (not amendable to resection with curative intent) or metastatic solid tumors who have failed available therapies (including anti-PD-1/PD-L1 therapy) or who are intolerant to, or ineligible for, standard treatment received verzistobart 1000 mg intravenously Q3W as monotherapy in two 21-day cycles. Participants then received verzistobart 1000 mg Q3W and retifanlimab 375 mg Q3W as separate consecutive intravenous infusions.
|
|---|---|---|---|---|---|---|
|
Phase 2: Disease Control Rate (DCR)
|
31.3 percentage of participants
Interval 11.0 to 58.7
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: up to 325 daysPopulation: RECIST Evaluable Analysis Set. Median PFS was estimated using the Kaplan-Meier method. The confidence interval was calculated using the method of Brookmeyer and Crowley.
PFS was defined as the time from the date of the first dose of study treatment until the earliest date of disease progression, as determined by investigator assessment of objective radiographic disease per RECIST v1.1, or death due to any cause.
Outcome measures
| Measure |
Phase 1, Part 1: Tuparstobart 350 mg Q2W + Verzistobart 400 mg Q2W
n=16 Participants
Participants with locally advanced (not amendable to resection with curative intent) or metastatic solid tumors that have failed available therapies (including anti-programmed cell death protein 1/programmed cell death ligand 1 \[PD-1/PD-L1\] therapy) or who are intolerant to, or ineligible for, standard treatment received tuparstobart 350 mg once every 2 weeks (Q2W) and verzistobart 400 mg Q2W as separate consecutive intravenous infusions.
|
Phase 1, Part 2: Tuparstobart 350 mg Q2W + Verzistobart 400 mg Q2W + Retifanlimab 500 mg Q4W
Participants with locally advanced (not amendable to resection with curative intent) or metastatic solid tumors that have failed available therapies (including anti-PD-1/PD-L1 therapy) or who are intolerant to, or ineligible for, standard treatment received tuparstobart 350 mg Q2W, verzistobart 400 mg Q2W, and retifanlimab 500 mg once every 4 weeks (Q4W) as separate consecutive intravenous infusions.
|
Phase 1, Part 3: Tuparstobart 450 mg Q3W; Tuparstobart 450 mg Q3W + Retifanlimab 375 mg Q3W
Participants with locally advanced (not amendable to resection with curative intent) or metastatic solid tumors that have failed available therapies (including anti-PD-1/PD-L1 therapy) or who are intolerant to, or ineligible for, standard treatment received tuparstobart 450 mg intravenously once every 3 weeks (Q3W) as monotherapy in two 21-day cycles. Participants then received tuparstobart 450 mg Q3W and retifanlimab 375 mg Q3W as separate consecutive intravenous infusions.
|
Phase 1, Part 3: Tuparstobart 750 mg Q3W; Tuparstobart 750 mg Q3W + Retifanlimab 375 mg Q3W
Participants with locally advanced (not amendable to resection with curative intent) or metastatic solid tumors who have failed available therapies (including anti-PD-1/PD-L1 therapy) or who are intolerant to, or ineligible for, standard treatment received tuparstobart 750 mg intravenously Q3W as monotherapy in two 21-day cycles. Participants then received tuparstobart 750 mg Q3W and retifanlimab 375 mg Q3W as separate consecutive intravenous infusions.
|
Phase 1, Part 3: Verzistobart 500 mg Q3W; Verzistobart 500 mg Q3W + Retifanlimab 375 mg Q3W
Participants with locally advanced (not amendable to resection with curative intent) or metastatic solid tumors who have failed available therapies (including anti-PD-1/PD-L1 therapy) or who are intolerant to, or ineligible for, standard treatment received verzistobart 500 mg intravenously Q3W as monotherapy in two 21-day cycles. Participants then received verzistobart 500 mg Q3W and retifanlimab 375 mg Q3W as separate consecutive intravenous infusions.
|
Phase 1, Part 3: Verzistobart 1000 mg Q3W; Verzistobart 1000 mg Q3W + Retifanlimab 375 mg Q3W
Participants with locally advanced (not amendable to resection with curative intent) or metastatic solid tumors who have failed available therapies (including anti-PD-1/PD-L1 therapy) or who are intolerant to, or ineligible for, standard treatment received verzistobart 1000 mg intravenously Q3W as monotherapy in two 21-day cycles. Participants then received verzistobart 1000 mg Q3W and retifanlimab 375 mg Q3W as separate consecutive intravenous infusions.
|
|---|---|---|---|---|---|---|
|
Phase 2: Progression-free Survival (PFS)
|
1.87 months
Interval 1.74 to 3.61
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: up to 415 daysPopulation: Full Analysis Set
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE was defined as an AE either reported for the first time or the worsening of a pre-existing event, after the first dose of study drug until 90 days after the last dose of study drug.
Outcome measures
| Measure |
Phase 1, Part 1: Tuparstobart 350 mg Q2W + Verzistobart 400 mg Q2W
n=16 Participants
Participants with locally advanced (not amendable to resection with curative intent) or metastatic solid tumors that have failed available therapies (including anti-programmed cell death protein 1/programmed cell death ligand 1 \[PD-1/PD-L1\] therapy) or who are intolerant to, or ineligible for, standard treatment received tuparstobart 350 mg once every 2 weeks (Q2W) and verzistobart 400 mg Q2W as separate consecutive intravenous infusions.
|
Phase 1, Part 2: Tuparstobart 350 mg Q2W + Verzistobart 400 mg Q2W + Retifanlimab 500 mg Q4W
Participants with locally advanced (not amendable to resection with curative intent) or metastatic solid tumors that have failed available therapies (including anti-PD-1/PD-L1 therapy) or who are intolerant to, or ineligible for, standard treatment received tuparstobart 350 mg Q2W, verzistobart 400 mg Q2W, and retifanlimab 500 mg once every 4 weeks (Q4W) as separate consecutive intravenous infusions.
|
Phase 1, Part 3: Tuparstobart 450 mg Q3W; Tuparstobart 450 mg Q3W + Retifanlimab 375 mg Q3W
Participants with locally advanced (not amendable to resection with curative intent) or metastatic solid tumors that have failed available therapies (including anti-PD-1/PD-L1 therapy) or who are intolerant to, or ineligible for, standard treatment received tuparstobart 450 mg intravenously once every 3 weeks (Q3W) as monotherapy in two 21-day cycles. Participants then received tuparstobart 450 mg Q3W and retifanlimab 375 mg Q3W as separate consecutive intravenous infusions.
|
Phase 1, Part 3: Tuparstobart 750 mg Q3W; Tuparstobart 750 mg Q3W + Retifanlimab 375 mg Q3W
Participants with locally advanced (not amendable to resection with curative intent) or metastatic solid tumors who have failed available therapies (including anti-PD-1/PD-L1 therapy) or who are intolerant to, or ineligible for, standard treatment received tuparstobart 750 mg intravenously Q3W as monotherapy in two 21-day cycles. Participants then received tuparstobart 750 mg Q3W and retifanlimab 375 mg Q3W as separate consecutive intravenous infusions.
|
Phase 1, Part 3: Verzistobart 500 mg Q3W; Verzistobart 500 mg Q3W + Retifanlimab 375 mg Q3W
Participants with locally advanced (not amendable to resection with curative intent) or metastatic solid tumors who have failed available therapies (including anti-PD-1/PD-L1 therapy) or who are intolerant to, or ineligible for, standard treatment received verzistobart 500 mg intravenously Q3W as monotherapy in two 21-day cycles. Participants then received verzistobart 500 mg Q3W and retifanlimab 375 mg Q3W as separate consecutive intravenous infusions.
|
Phase 1, Part 3: Verzistobart 1000 mg Q3W; Verzistobart 1000 mg Q3W + Retifanlimab 375 mg Q3W
Participants with locally advanced (not amendable to resection with curative intent) or metastatic solid tumors who have failed available therapies (including anti-PD-1/PD-L1 therapy) or who are intolerant to, or ineligible for, standard treatment received verzistobart 1000 mg intravenously Q3W as monotherapy in two 21-day cycles. Participants then received verzistobart 1000 mg Q3W and retifanlimab 375 mg Q3W as separate consecutive intravenous infusions.
|
|---|---|---|---|---|---|---|
|
Phase 2: Number of Participants With Any TEAE
|
14 Participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: up to 415 daysPopulation: Full Analysis Set
The severity of AEs was assessed using CTCAE version 5.0 Grades 1 through 5. Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment not indicated. Grade 2: moderate; minimal, local, or noninvasive treatment indicated; limiting age-appropriate activities of daily living. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent treatment indicated. Grade 5: fatal. An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A TEAE was defined as an AE reported for the first time or the worsening of a pre-existing event after the first dose of study treatment.
Outcome measures
| Measure |
Phase 1, Part 1: Tuparstobart 350 mg Q2W + Verzistobart 400 mg Q2W
n=16 Participants
Participants with locally advanced (not amendable to resection with curative intent) or metastatic solid tumors that have failed available therapies (including anti-programmed cell death protein 1/programmed cell death ligand 1 \[PD-1/PD-L1\] therapy) or who are intolerant to, or ineligible for, standard treatment received tuparstobart 350 mg once every 2 weeks (Q2W) and verzistobart 400 mg Q2W as separate consecutive intravenous infusions.
|
Phase 1, Part 2: Tuparstobart 350 mg Q2W + Verzistobart 400 mg Q2W + Retifanlimab 500 mg Q4W
Participants with locally advanced (not amendable to resection with curative intent) or metastatic solid tumors that have failed available therapies (including anti-PD-1/PD-L1 therapy) or who are intolerant to, or ineligible for, standard treatment received tuparstobart 350 mg Q2W, verzistobart 400 mg Q2W, and retifanlimab 500 mg once every 4 weeks (Q4W) as separate consecutive intravenous infusions.
|
Phase 1, Part 3: Tuparstobart 450 mg Q3W; Tuparstobart 450 mg Q3W + Retifanlimab 375 mg Q3W
Participants with locally advanced (not amendable to resection with curative intent) or metastatic solid tumors that have failed available therapies (including anti-PD-1/PD-L1 therapy) or who are intolerant to, or ineligible for, standard treatment received tuparstobart 450 mg intravenously once every 3 weeks (Q3W) as monotherapy in two 21-day cycles. Participants then received tuparstobart 450 mg Q3W and retifanlimab 375 mg Q3W as separate consecutive intravenous infusions.
|
Phase 1, Part 3: Tuparstobart 750 mg Q3W; Tuparstobart 750 mg Q3W + Retifanlimab 375 mg Q3W
Participants with locally advanced (not amendable to resection with curative intent) or metastatic solid tumors who have failed available therapies (including anti-PD-1/PD-L1 therapy) or who are intolerant to, or ineligible for, standard treatment received tuparstobart 750 mg intravenously Q3W as monotherapy in two 21-day cycles. Participants then received tuparstobart 750 mg Q3W and retifanlimab 375 mg Q3W as separate consecutive intravenous infusions.
|
Phase 1, Part 3: Verzistobart 500 mg Q3W; Verzistobart 500 mg Q3W + Retifanlimab 375 mg Q3W
Participants with locally advanced (not amendable to resection with curative intent) or metastatic solid tumors who have failed available therapies (including anti-PD-1/PD-L1 therapy) or who are intolerant to, or ineligible for, standard treatment received verzistobart 500 mg intravenously Q3W as monotherapy in two 21-day cycles. Participants then received verzistobart 500 mg Q3W and retifanlimab 375 mg Q3W as separate consecutive intravenous infusions.
|
Phase 1, Part 3: Verzistobart 1000 mg Q3W; Verzistobart 1000 mg Q3W + Retifanlimab 375 mg Q3W
Participants with locally advanced (not amendable to resection with curative intent) or metastatic solid tumors who have failed available therapies (including anti-PD-1/PD-L1 therapy) or who are intolerant to, or ineligible for, standard treatment received verzistobart 1000 mg intravenously Q3W as monotherapy in two 21-day cycles. Participants then received verzistobart 1000 mg Q3W and retifanlimab 375 mg Q3W as separate consecutive intravenous infusions.
|
|---|---|---|---|---|---|---|
|
Phase 2: Number of Participants With Any ≥Grade 3 TEAE
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: up to 1058 daysPopulation: Full Analysis Set. The confidence interval was calculated based on the exact method for binomial distributions.
ORR was defined as the percentage of participants with a CR or PR, as determined by investigator assessment of radiographic disease assessments per RECIST v1.1.
Outcome measures
| Measure |
Phase 1, Part 1: Tuparstobart 350 mg Q2W + Verzistobart 400 mg Q2W
n=10 Participants
Participants with locally advanced (not amendable to resection with curative intent) or metastatic solid tumors that have failed available therapies (including anti-programmed cell death protein 1/programmed cell death ligand 1 \[PD-1/PD-L1\] therapy) or who are intolerant to, or ineligible for, standard treatment received tuparstobart 350 mg once every 2 weeks (Q2W) and verzistobart 400 mg Q2W as separate consecutive intravenous infusions.
|
Phase 1, Part 2: Tuparstobart 350 mg Q2W + Verzistobart 400 mg Q2W + Retifanlimab 500 mg Q4W
n=11 Participants
Participants with locally advanced (not amendable to resection with curative intent) or metastatic solid tumors that have failed available therapies (including anti-PD-1/PD-L1 therapy) or who are intolerant to, or ineligible for, standard treatment received tuparstobart 350 mg Q2W, verzistobart 400 mg Q2W, and retifanlimab 500 mg once every 4 weeks (Q4W) as separate consecutive intravenous infusions.
|
Phase 1, Part 3: Tuparstobart 450 mg Q3W; Tuparstobart 450 mg Q3W + Retifanlimab 375 mg Q3W
n=6 Participants
Participants with locally advanced (not amendable to resection with curative intent) or metastatic solid tumors that have failed available therapies (including anti-PD-1/PD-L1 therapy) or who are intolerant to, or ineligible for, standard treatment received tuparstobart 450 mg intravenously once every 3 weeks (Q3W) as monotherapy in two 21-day cycles. Participants then received tuparstobart 450 mg Q3W and retifanlimab 375 mg Q3W as separate consecutive intravenous infusions.
|
Phase 1, Part 3: Tuparstobart 750 mg Q3W; Tuparstobart 750 mg Q3W + Retifanlimab 375 mg Q3W
n=6 Participants
Participants with locally advanced (not amendable to resection with curative intent) or metastatic solid tumors who have failed available therapies (including anti-PD-1/PD-L1 therapy) or who are intolerant to, or ineligible for, standard treatment received tuparstobart 750 mg intravenously Q3W as monotherapy in two 21-day cycles. Participants then received tuparstobart 750 mg Q3W and retifanlimab 375 mg Q3W as separate consecutive intravenous infusions.
|
Phase 1, Part 3: Verzistobart 500 mg Q3W; Verzistobart 500 mg Q3W + Retifanlimab 375 mg Q3W
n=6 Participants
Participants with locally advanced (not amendable to resection with curative intent) or metastatic solid tumors who have failed available therapies (including anti-PD-1/PD-L1 therapy) or who are intolerant to, or ineligible for, standard treatment received verzistobart 500 mg intravenously Q3W as monotherapy in two 21-day cycles. Participants then received verzistobart 500 mg Q3W and retifanlimab 375 mg Q3W as separate consecutive intravenous infusions.
|
Phase 1, Part 3: Verzistobart 1000 mg Q3W; Verzistobart 1000 mg Q3W + Retifanlimab 375 mg Q3W
n=6 Participants
Participants with locally advanced (not amendable to resection with curative intent) or metastatic solid tumors who have failed available therapies (including anti-PD-1/PD-L1 therapy) or who are intolerant to, or ineligible for, standard treatment received verzistobart 1000 mg intravenously Q3W as monotherapy in two 21-day cycles. Participants then received verzistobart 1000 mg Q3W and retifanlimab 375 mg Q3W as separate consecutive intravenous infusions.
|
|---|---|---|---|---|---|---|
|
Phase 1: ORR
|
0.0 percentage of participants
Interval 0.0 to 30.8
|
9.1 percentage of participants
Interval 0.2 to 41.3
|
0.0 percentage of participants
Interval 0.0 to 45.9
|
16.7 percentage of participants
Interval 0.4 to 64.1
|
0.0 percentage of participants
Interval 0.0 to 45.9
|
0.0 percentage of participants
Interval 0.0 to 45.9
|
SECONDARY outcome
Timeframe: up to 1058 daysPopulation: Full Analysis Set. Only participants with CR or PR were analyzed.
DOR was defined as the time from the earliest date of disease response (CR or PR) until the earliest date of disease progression, as determined by investigator assessment of radiographic disease per RECIST v1.1, or death from any cause, if it occurred sooner than progression.
Outcome measures
| Measure |
Phase 1, Part 1: Tuparstobart 350 mg Q2W + Verzistobart 400 mg Q2W
Participants with locally advanced (not amendable to resection with curative intent) or metastatic solid tumors that have failed available therapies (including anti-programmed cell death protein 1/programmed cell death ligand 1 \[PD-1/PD-L1\] therapy) or who are intolerant to, or ineligible for, standard treatment received tuparstobart 350 mg once every 2 weeks (Q2W) and verzistobart 400 mg Q2W as separate consecutive intravenous infusions.
|
Phase 1, Part 2: Tuparstobart 350 mg Q2W + Verzistobart 400 mg Q2W + Retifanlimab 500 mg Q4W
n=1 Participants
Participants with locally advanced (not amendable to resection with curative intent) or metastatic solid tumors that have failed available therapies (including anti-PD-1/PD-L1 therapy) or who are intolerant to, or ineligible for, standard treatment received tuparstobart 350 mg Q2W, verzistobart 400 mg Q2W, and retifanlimab 500 mg once every 4 weeks (Q4W) as separate consecutive intravenous infusions.
|
Phase 1, Part 3: Tuparstobart 450 mg Q3W; Tuparstobart 450 mg Q3W + Retifanlimab 375 mg Q3W
Participants with locally advanced (not amendable to resection with curative intent) or metastatic solid tumors that have failed available therapies (including anti-PD-1/PD-L1 therapy) or who are intolerant to, or ineligible for, standard treatment received tuparstobart 450 mg intravenously once every 3 weeks (Q3W) as monotherapy in two 21-day cycles. Participants then received tuparstobart 450 mg Q3W and retifanlimab 375 mg Q3W as separate consecutive intravenous infusions.
|
Phase 1, Part 3: Tuparstobart 750 mg Q3W; Tuparstobart 750 mg Q3W + Retifanlimab 375 mg Q3W
n=1 Participants
Participants with locally advanced (not amendable to resection with curative intent) or metastatic solid tumors who have failed available therapies (including anti-PD-1/PD-L1 therapy) or who are intolerant to, or ineligible for, standard treatment received tuparstobart 750 mg intravenously Q3W as monotherapy in two 21-day cycles. Participants then received tuparstobart 750 mg Q3W and retifanlimab 375 mg Q3W as separate consecutive intravenous infusions.
|
Phase 1, Part 3: Verzistobart 500 mg Q3W; Verzistobart 500 mg Q3W + Retifanlimab 375 mg Q3W
Participants with locally advanced (not amendable to resection with curative intent) or metastatic solid tumors who have failed available therapies (including anti-PD-1/PD-L1 therapy) or who are intolerant to, or ineligible for, standard treatment received verzistobart 500 mg intravenously Q3W as monotherapy in two 21-day cycles. Participants then received verzistobart 500 mg Q3W and retifanlimab 375 mg Q3W as separate consecutive intravenous infusions.
|
Phase 1, Part 3: Verzistobart 1000 mg Q3W; Verzistobart 1000 mg Q3W + Retifanlimab 375 mg Q3W
Participants with locally advanced (not amendable to resection with curative intent) or metastatic solid tumors who have failed available therapies (including anti-PD-1/PD-L1 therapy) or who are intolerant to, or ineligible for, standard treatment received verzistobart 1000 mg intravenously Q3W as monotherapy in two 21-day cycles. Participants then received verzistobart 1000 mg Q3W and retifanlimab 375 mg Q3W as separate consecutive intravenous infusions.
|
|---|---|---|---|---|---|---|
|
Phase 1: DOR
|
—
|
NA days
The median and the upper and lower limits of the confidence interval were not estimable because there was an insufficient number of participants with disease response (CR and PR).
|
—
|
NA days
The median and the upper and lower limits of the confidence interval were not estimable because there was an insufficient number of participants with disease response (CR and PR).
|
—
|
—
|
SECONDARY outcome
Timeframe: up to 1058 days beyond Day 56Population: Full Analysis Set. The confidence interval was calculated based on the exact method for binomial distributions.
DCR was defined as the percentage of participants with CR, PR, or SD as best on study response and or after Day 56.
Outcome measures
| Measure |
Phase 1, Part 1: Tuparstobart 350 mg Q2W + Verzistobart 400 mg Q2W
n=10 Participants
Participants with locally advanced (not amendable to resection with curative intent) or metastatic solid tumors that have failed available therapies (including anti-programmed cell death protein 1/programmed cell death ligand 1 \[PD-1/PD-L1\] therapy) or who are intolerant to, or ineligible for, standard treatment received tuparstobart 350 mg once every 2 weeks (Q2W) and verzistobart 400 mg Q2W as separate consecutive intravenous infusions.
|
Phase 1, Part 2: Tuparstobart 350 mg Q2W + Verzistobart 400 mg Q2W + Retifanlimab 500 mg Q4W
n=11 Participants
Participants with locally advanced (not amendable to resection with curative intent) or metastatic solid tumors that have failed available therapies (including anti-PD-1/PD-L1 therapy) or who are intolerant to, or ineligible for, standard treatment received tuparstobart 350 mg Q2W, verzistobart 400 mg Q2W, and retifanlimab 500 mg once every 4 weeks (Q4W) as separate consecutive intravenous infusions.
|
Phase 1, Part 3: Tuparstobart 450 mg Q3W; Tuparstobart 450 mg Q3W + Retifanlimab 375 mg Q3W
n=6 Participants
Participants with locally advanced (not amendable to resection with curative intent) or metastatic solid tumors that have failed available therapies (including anti-PD-1/PD-L1 therapy) or who are intolerant to, or ineligible for, standard treatment received tuparstobart 450 mg intravenously once every 3 weeks (Q3W) as monotherapy in two 21-day cycles. Participants then received tuparstobart 450 mg Q3W and retifanlimab 375 mg Q3W as separate consecutive intravenous infusions.
|
Phase 1, Part 3: Tuparstobart 750 mg Q3W; Tuparstobart 750 mg Q3W + Retifanlimab 375 mg Q3W
n=6 Participants
Participants with locally advanced (not amendable to resection with curative intent) or metastatic solid tumors who have failed available therapies (including anti-PD-1/PD-L1 therapy) or who are intolerant to, or ineligible for, standard treatment received tuparstobart 750 mg intravenously Q3W as monotherapy in two 21-day cycles. Participants then received tuparstobart 750 mg Q3W and retifanlimab 375 mg Q3W as separate consecutive intravenous infusions.
|
Phase 1, Part 3: Verzistobart 500 mg Q3W; Verzistobart 500 mg Q3W + Retifanlimab 375 mg Q3W
n=6 Participants
Participants with locally advanced (not amendable to resection with curative intent) or metastatic solid tumors who have failed available therapies (including anti-PD-1/PD-L1 therapy) or who are intolerant to, or ineligible for, standard treatment received verzistobart 500 mg intravenously Q3W as monotherapy in two 21-day cycles. Participants then received verzistobart 500 mg Q3W and retifanlimab 375 mg Q3W as separate consecutive intravenous infusions.
|
Phase 1, Part 3: Verzistobart 1000 mg Q3W; Verzistobart 1000 mg Q3W + Retifanlimab 375 mg Q3W
n=6 Participants
Participants with locally advanced (not amendable to resection with curative intent) or metastatic solid tumors who have failed available therapies (including anti-PD-1/PD-L1 therapy) or who are intolerant to, or ineligible for, standard treatment received verzistobart 1000 mg intravenously Q3W as monotherapy in two 21-day cycles. Participants then received verzistobart 1000 mg Q3W and retifanlimab 375 mg Q3W as separate consecutive intravenous infusions.
|
|---|---|---|---|---|---|---|
|
Phase 1: DCR
|
10.0 percentage of participants
Interval 0.3 to 44.5
|
27.3 percentage of participants
Interval 6.0 to 61.0
|
83.3 percentage of participants
Interval 35.9 to 99.6
|
50.0 percentage of participants
Interval 11.8 to 88.2
|
0.0 percentage of participants
Interval 0.0 to 45.9
|
16.7 percentage of participants
Interval 0.4 to 64.1
|
SECONDARY outcome
Timeframe: up to 1058 daysPopulation: Full Analysis Set. Median PFS was estimated using the Kaplan-Meier method. The confidence interval was calculated using the method of Brookmeyer and Crowley.
PFS was defined as the time from the date of the first dose of study treatment until the earliest date of disease progression, as determined by investigator assessment of objective radiographic disease per RECIST v1.1, or death due to any cause.
Outcome measures
| Measure |
Phase 1, Part 1: Tuparstobart 350 mg Q2W + Verzistobart 400 mg Q2W
n=10 Participants
Participants with locally advanced (not amendable to resection with curative intent) or metastatic solid tumors that have failed available therapies (including anti-programmed cell death protein 1/programmed cell death ligand 1 \[PD-1/PD-L1\] therapy) or who are intolerant to, or ineligible for, standard treatment received tuparstobart 350 mg once every 2 weeks (Q2W) and verzistobart 400 mg Q2W as separate consecutive intravenous infusions.
|
Phase 1, Part 2: Tuparstobart 350 mg Q2W + Verzistobart 400 mg Q2W + Retifanlimab 500 mg Q4W
n=11 Participants
Participants with locally advanced (not amendable to resection with curative intent) or metastatic solid tumors that have failed available therapies (including anti-PD-1/PD-L1 therapy) or who are intolerant to, or ineligible for, standard treatment received tuparstobart 350 mg Q2W, verzistobart 400 mg Q2W, and retifanlimab 500 mg once every 4 weeks (Q4W) as separate consecutive intravenous infusions.
|
Phase 1, Part 3: Tuparstobart 450 mg Q3W; Tuparstobart 450 mg Q3W + Retifanlimab 375 mg Q3W
n=6 Participants
Participants with locally advanced (not amendable to resection with curative intent) or metastatic solid tumors that have failed available therapies (including anti-PD-1/PD-L1 therapy) or who are intolerant to, or ineligible for, standard treatment received tuparstobart 450 mg intravenously once every 3 weeks (Q3W) as monotherapy in two 21-day cycles. Participants then received tuparstobart 450 mg Q3W and retifanlimab 375 mg Q3W as separate consecutive intravenous infusions.
|
Phase 1, Part 3: Tuparstobart 750 mg Q3W; Tuparstobart 750 mg Q3W + Retifanlimab 375 mg Q3W
n=6 Participants
Participants with locally advanced (not amendable to resection with curative intent) or metastatic solid tumors who have failed available therapies (including anti-PD-1/PD-L1 therapy) or who are intolerant to, or ineligible for, standard treatment received tuparstobart 750 mg intravenously Q3W as monotherapy in two 21-day cycles. Participants then received tuparstobart 750 mg Q3W and retifanlimab 375 mg Q3W as separate consecutive intravenous infusions.
|
Phase 1, Part 3: Verzistobart 500 mg Q3W; Verzistobart 500 mg Q3W + Retifanlimab 375 mg Q3W
n=6 Participants
Participants with locally advanced (not amendable to resection with curative intent) or metastatic solid tumors who have failed available therapies (including anti-PD-1/PD-L1 therapy) or who are intolerant to, or ineligible for, standard treatment received verzistobart 500 mg intravenously Q3W as monotherapy in two 21-day cycles. Participants then received verzistobart 500 mg Q3W and retifanlimab 375 mg Q3W as separate consecutive intravenous infusions.
|
Phase 1, Part 3: Verzistobart 1000 mg Q3W; Verzistobart 1000 mg Q3W + Retifanlimab 375 mg Q3W
n=6 Participants
Participants with locally advanced (not amendable to resection with curative intent) or metastatic solid tumors who have failed available therapies (including anti-PD-1/PD-L1 therapy) or who are intolerant to, or ineligible for, standard treatment received verzistobart 1000 mg intravenously Q3W as monotherapy in two 21-day cycles. Participants then received verzistobart 1000 mg Q3W and retifanlimab 375 mg Q3W as separate consecutive intravenous infusions.
|
|---|---|---|---|---|---|---|
|
Phase 1: PFS
|
1.74 months
Interval 1.28 to 4.96
|
1.87 months
Interval 1.64 to 3.68
|
7.79 months
Interval 1.91 to
The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
|
3.88 months
Interval 1.38 to
The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
|
1.87 months
Interval 1.35 to
The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
|
1.89 months
Interval 1.87 to
The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
|
Adverse Events
Phase 1, Part 1: Tuparstobart 350 mg Q2W + Verzistobart 400 mg Q2W
Serious events: 4 serious events
Other events: 8 other events
Deaths: 9 deaths
Phase 1, Part 2: Tuparstobart 350 mg Q2W + Verzistobart 400 mg Q2W + Retifanlimab 500 mg Q4W
Serious events: 2 serious events
Other events: 11 other events
Deaths: 8 deaths
Phase 1, Part 3: Tuparstobart 450 mg Q3W; Tuparstobart 450 mg Q3W + Retifanlimab 375 mg Q3W
Serious events: 1 serious events
Other events: 6 other events
Deaths: 2 deaths
Phase 1, Part 3: Tuparstobart 750 mg Q3W; Tuparstobart 750 mg Q3W + Retifanlimab 375 mg Q3W
Serious events: 4 serious events
Other events: 5 other events
Deaths: 1 deaths
Phase 1, Part 3: Verzistobart 500 mg Q3W; Verzistobart 500 mg Q3W + Retifanlimab 375 mg Q3W
Serious events: 3 serious events
Other events: 6 other events
Deaths: 3 deaths
Phase 1, Part 3: Verzistobart 1000 mg Q3W; Verzistobart 1000 mg Q3W + Retifanlimab 375 mg Q3W
Serious events: 1 serious events
Other events: 5 other events
Deaths: 2 deaths
Phase 2, Cohort A: Tuparstobart 350 mg Q2W + Verzistobart 400 mg Q2W + Retifanlimab 500 mg Q4W
Serious events: 2 serious events
Other events: 14 other events
Deaths: 4 deaths
Total
Serious events: 17 serious events
Other events: 55 other events
Deaths: 29 deaths
Serious adverse events
| Measure |
Phase 1, Part 1: Tuparstobart 350 mg Q2W + Verzistobart 400 mg Q2W
n=10 participants at risk
Participants with locally advanced (not amendable to resection with curative intent) or metastatic solid tumors that have failed available therapies (including anti-programmed cell death protein 1/programmed cell death ligand 1 \[PD-1/PD-L1\] therapy) or who are intolerant to, or ineligible for, standard treatment received tuparstobart 350 mg once every 2 weeks (Q2W) and verzistobart 400 mg Q2W as separate consecutive intravenous infusions.
|
Phase 1, Part 2: Tuparstobart 350 mg Q2W + Verzistobart 400 mg Q2W + Retifanlimab 500 mg Q4W
n=11 participants at risk
Participants with locally advanced (not amendable to resection with curative intent) or metastatic solid tumors that have failed available therapies (including anti-PD-1/PD-L1 therapy) or who are intolerant to, or ineligible for, standard treatment received tuparstobart 350 mg Q2W, verzistobart 400 mg Q2W, and retifanlimab 500 mg once every 4 weeks (Q4W) as separate consecutive intravenous infusions.
|
Phase 1, Part 3: Tuparstobart 450 mg Q3W; Tuparstobart 450 mg Q3W + Retifanlimab 375 mg Q3W
n=6 participants at risk
Participants with locally advanced (not amendable to resection with curative intent) or metastatic solid tumors that have failed available therapies (including anti-PD-1/PD-L1 therapy) or who are intolerant to, or ineligible for, standard treatment received tuparstobart 450 mg intravenously once every 3 weeks (Q3W) as monotherapy in two 21-day cycles. Participants then received tuparstobart 450 mg Q3W and retifanlimab 375 mg Q3W as separate consecutive intravenous infusions.
|
Phase 1, Part 3: Tuparstobart 750 mg Q3W; Tuparstobart 750 mg Q3W + Retifanlimab 375 mg Q3W
n=6 participants at risk
Participants with locally advanced (not amendable to resection with curative intent) or metastatic solid tumors who have failed available therapies (including anti-PD-1/PD-L1 therapy) or who are intolerant to, or ineligible for, standard treatment received tuparstobart 750 mg intravenously Q3W as monotherapy in two 21-day cycles. Participants then received tuparstobart 750 mg Q3W and retifanlimab 375 mg Q3W as separate consecutive intravenous infusions.
|
Phase 1, Part 3: Verzistobart 500 mg Q3W; Verzistobart 500 mg Q3W + Retifanlimab 375 mg Q3W
n=6 participants at risk
Participants with locally advanced (not amendable to resection with curative intent) or metastatic solid tumors who have failed available therapies (including anti-PD-1/PD-L1 therapy) or who are intolerant to, or ineligible for, standard treatment received verzistobart 500 mg intravenously Q3W as monotherapy in two 21-day cycles. Participants then received verzistobart 500 mg Q3W and retifanlimab 375 mg Q3W as separate consecutive intravenous infusions.
|
Phase 1, Part 3: Verzistobart 1000 mg Q3W; Verzistobart 1000 mg Q3W + Retifanlimab 375 mg Q3W
n=6 participants at risk
Participants with locally advanced (not amendable to resection with curative intent) or metastatic solid tumors who have failed available therapies (including anti-PD-1/PD-L1 therapy) or who are intolerant to, or ineligible for, standard treatment received verzistobart 1000 mg intravenously Q3W as monotherapy in two 21-day cycles. Participants then received verzistobart 1000 mg Q3W and retifanlimab 375 mg Q3W as separate consecutive intravenous infusions.
|
Phase 2, Cohort A: Tuparstobart 350 mg Q2W + Verzistobart 400 mg Q2W + Retifanlimab 500 mg Q4W
n=16 participants at risk
Participants with histologically confirmed unresectable/metastatic melanoma whose disease failed prior anti-PD-1/PD-L1 therapy (alone or as part of a combination) and who met protocol-defined criteria received tuparstobart 350 mg Q2W, verzistobart 400 mg Q2W, and retifanlimab 500 mg Q4W as separate consecutive intravenous infusions.
|
Total
n=61 participants at risk
Total
|
|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/11 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
16.7%
1/6 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
16.7%
1/6 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
3.3%
2/61 • Number of events 2 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
9.1%
1/11 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/11 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
16.7%
1/6 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Infections and infestations
COVID-19
|
10.0%
1/10 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/11 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/11 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
16.7%
1/6 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/11 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
16.7%
1/6 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/11 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
16.7%
1/6 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
General disorders
Death
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/11 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
16.7%
1/6 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/11 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
16.7%
1/6 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
16.7%
1/6 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
3.3%
2/61 • Number of events 2 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
10.0%
1/10 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/11 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
16.7%
1/6 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
3.3%
2/61 • Number of events 2 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Infections and infestations
Haemophilus infection
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/11 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
16.7%
1/6 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/11 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
16.7%
1/6 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
10.0%
1/10 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/11 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Gastrointestinal disorders
Immune-mediated enterocolitis
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/11 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
16.7%
1/6 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/11 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
16.7%
1/6 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Cardiac disorders
Myocarditis
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
9.1%
1/11 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Gastrointestinal disorders
Pancreatitis
|
10.0%
1/10 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/11 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
General disorders
Pyrexia
|
10.0%
1/10 • Number of events 2 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/11 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
6.2%
1/16 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
3.3%
2/61 • Number of events 3 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
9.1%
1/11 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/11 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
16.7%
1/6 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/11 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
16.7%
1/6 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/11 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
16.7%
1/6 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
10.0%
1/10 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/11 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Infections and infestations
Sepsis
|
10.0%
1/10 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/11 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Infections and infestations
Skin infection
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/11 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
16.7%
1/6 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/11 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
6.2%
1/16 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Vascular disorders
Vasculitis
|
10.0%
1/10 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/11 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Reproductive system and breast disorders
Vulval haemorrhage
|
10.0%
1/10 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/11 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
Other adverse events
| Measure |
Phase 1, Part 1: Tuparstobart 350 mg Q2W + Verzistobart 400 mg Q2W
n=10 participants at risk
Participants with locally advanced (not amendable to resection with curative intent) or metastatic solid tumors that have failed available therapies (including anti-programmed cell death protein 1/programmed cell death ligand 1 \[PD-1/PD-L1\] therapy) or who are intolerant to, or ineligible for, standard treatment received tuparstobart 350 mg once every 2 weeks (Q2W) and verzistobart 400 mg Q2W as separate consecutive intravenous infusions.
|
Phase 1, Part 2: Tuparstobart 350 mg Q2W + Verzistobart 400 mg Q2W + Retifanlimab 500 mg Q4W
n=11 participants at risk
Participants with locally advanced (not amendable to resection with curative intent) or metastatic solid tumors that have failed available therapies (including anti-PD-1/PD-L1 therapy) or who are intolerant to, or ineligible for, standard treatment received tuparstobart 350 mg Q2W, verzistobart 400 mg Q2W, and retifanlimab 500 mg once every 4 weeks (Q4W) as separate consecutive intravenous infusions.
|
Phase 1, Part 3: Tuparstobart 450 mg Q3W; Tuparstobart 450 mg Q3W + Retifanlimab 375 mg Q3W
n=6 participants at risk
Participants with locally advanced (not amendable to resection with curative intent) or metastatic solid tumors that have failed available therapies (including anti-PD-1/PD-L1 therapy) or who are intolerant to, or ineligible for, standard treatment received tuparstobart 450 mg intravenously once every 3 weeks (Q3W) as monotherapy in two 21-day cycles. Participants then received tuparstobart 450 mg Q3W and retifanlimab 375 mg Q3W as separate consecutive intravenous infusions.
|
Phase 1, Part 3: Tuparstobart 750 mg Q3W; Tuparstobart 750 mg Q3W + Retifanlimab 375 mg Q3W
n=6 participants at risk
Participants with locally advanced (not amendable to resection with curative intent) or metastatic solid tumors who have failed available therapies (including anti-PD-1/PD-L1 therapy) or who are intolerant to, or ineligible for, standard treatment received tuparstobart 750 mg intravenously Q3W as monotherapy in two 21-day cycles. Participants then received tuparstobart 750 mg Q3W and retifanlimab 375 mg Q3W as separate consecutive intravenous infusions.
|
Phase 1, Part 3: Verzistobart 500 mg Q3W; Verzistobart 500 mg Q3W + Retifanlimab 375 mg Q3W
n=6 participants at risk
Participants with locally advanced (not amendable to resection with curative intent) or metastatic solid tumors who have failed available therapies (including anti-PD-1/PD-L1 therapy) or who are intolerant to, or ineligible for, standard treatment received verzistobart 500 mg intravenously Q3W as monotherapy in two 21-day cycles. Participants then received verzistobart 500 mg Q3W and retifanlimab 375 mg Q3W as separate consecutive intravenous infusions.
|
Phase 1, Part 3: Verzistobart 1000 mg Q3W; Verzistobart 1000 mg Q3W + Retifanlimab 375 mg Q3W
n=6 participants at risk
Participants with locally advanced (not amendable to resection with curative intent) or metastatic solid tumors who have failed available therapies (including anti-PD-1/PD-L1 therapy) or who are intolerant to, or ineligible for, standard treatment received verzistobart 1000 mg intravenously Q3W as monotherapy in two 21-day cycles. Participants then received verzistobart 1000 mg Q3W and retifanlimab 375 mg Q3W as separate consecutive intravenous infusions.
|
Phase 2, Cohort A: Tuparstobart 350 mg Q2W + Verzistobart 400 mg Q2W + Retifanlimab 500 mg Q4W
n=16 participants at risk
Participants with histologically confirmed unresectable/metastatic melanoma whose disease failed prior anti-PD-1/PD-L1 therapy (alone or as part of a combination) and who met protocol-defined criteria received tuparstobart 350 mg Q2W, verzistobart 400 mg Q2W, and retifanlimab 500 mg Q4W as separate consecutive intravenous infusions.
|
Total
n=61 participants at risk
Total
|
|---|---|---|---|---|---|---|---|---|
|
Investigations
Amylase increased
|
10.0%
1/10 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/11 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
16.7%
1/6 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
6.2%
1/16 • Number of events 2 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
4.9%
3/61 • Number of events 4 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/11 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
18.8%
3/16 • Number of events 3 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
4.9%
3/61 • Number of events 3 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
9.1%
1/11 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
6.2%
1/16 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
3.3%
2/61 • Number of events 2 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
27.3%
3/11 • Number of events 3 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
33.3%
2/6 • Number of events 2 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
33.3%
2/6 • Number of events 2 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
16.7%
1/6 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
6.2%
1/16 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
14.8%
9/61 • Number of events 9 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
10.0%
1/10 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
9.1%
1/11 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
3.3%
2/61 • Number of events 2 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Gastrointestinal disorders
Abdominal tenderness
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
9.1%
1/11 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Infections and infestations
Abscess oral
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
9.1%
1/11 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
9.1%
1/11 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Renal and urinary disorders
Acute kidney injury
|
10.0%
1/10 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/11 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/11 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
16.7%
1/6 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Investigations
Alanine aminotransferase increased
|
10.0%
1/10 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
9.1%
1/11 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
16.7%
1/6 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
16.7%
1/6 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
6.6%
4/61 • Number of events 4 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/11 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
16.7%
1/6 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Blood and lymphatic system disorders
Anaemia
|
30.0%
3/10 • Number of events 4 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
36.4%
4/11 • Number of events 4 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
33.3%
2/6 • Number of events 2 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
16.7%
1/6 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
33.3%
2/6 • Number of events 3 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
16.7%
1/6 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
18.8%
3/16 • Number of events 3 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
26.2%
16/61 • Number of events 18 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Psychiatric disorders
Anxiety
|
10.0%
1/10 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
9.1%
1/11 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
3.3%
2/61 • Number of events 2 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
General disorders
Application site paraesthesia
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
9.1%
1/11 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
27.3%
3/11 • Number of events 4 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
16.7%
1/6 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
16.7%
1/6 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
16.7%
1/6 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
9.8%
6/61 • Number of events 7 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
9.1%
1/11 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Gastrointestinal disorders
Ascites
|
10.0%
1/10 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/11 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
16.7%
1/6 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
3.3%
2/61 • Number of events 2 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
9.1%
1/11 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
16.7%
1/6 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
16.7%
1/6 • Number of events 3 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
4.9%
3/61 • Number of events 5 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.0%
1/10 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
27.3%
3/11 • Number of events 4 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
33.3%
2/6 • Number of events 3 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
12.5%
2/16 • Number of events 2 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
13.1%
8/61 • Number of events 10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/11 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
16.7%
1/6 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign bone neoplasm
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
9.1%
1/11 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Hepatobiliary disorders
Biliary dilatation
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
9.1%
1/11 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Investigations
Bilirubin conjugated increased
|
10.0%
1/10 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/11 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Investigations
Blood alkaline phosphatase increased
|
10.0%
1/10 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
9.1%
1/11 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
50.0%
3/6 • Number of events 4 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
16.7%
1/6 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
9.8%
6/61 • Number of events 7 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
9.1%
1/11 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Investigations
Blood creatinine increased
|
20.0%
2/10 • Number of events 3 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
18.2%
2/11 • Number of events 2 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
16.7%
1/6 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
8.2%
5/61 • Number of events 6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
10.0%
1/10 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
9.1%
1/11 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
3.3%
2/61 • Number of events 2 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Infections and infestations
COVID-19
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
9.1%
1/11 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
16.7%
1/6 • Number of events 2 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
16.7%
1/6 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
12.5%
2/16 • Number of events 2 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
8.2%
5/61 • Number of events 6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Eye disorders
Cataract
|
10.0%
1/10 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/11 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
9.1%
1/11 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
General disorders
Chills
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
18.2%
2/11 • Number of events 2 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
6.2%
1/16 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
4.9%
3/61 • Number of events 3 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
9.1%
1/11 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
9.1%
1/11 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Gastrointestinal disorders
Constipation
|
10.0%
1/10 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
9.1%
1/11 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
33.3%
2/6 • Number of events 2 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
16.7%
1/6 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
12.5%
2/16 • Number of events 2 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
11.5%
7/61 • Number of events 7 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/11 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
16.7%
1/6 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
16.7%
1/6 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
3.3%
2/61 • Number of events 2 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Injury, poisoning and procedural complications
Craniofacial fracture
|
10.0%
1/10 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/11 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
9.1%
1/11 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
33.3%
2/6 • Number of events 2 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
16.7%
1/6 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
18.8%
3/16 • Number of events 4 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
11.5%
7/61 • Number of events 8 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Vascular disorders
Deep vein thrombosis
|
10.0%
1/10 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/11 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
6.2%
1/16 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
3.3%
2/61 • Number of events 2 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
18.2%
2/11 • Number of events 2 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
16.7%
1/6 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
16.7%
1/6 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
6.6%
4/61 • Number of events 4 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
10.0%
1/10 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/11 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Gastrointestinal disorders
Diarrhoea
|
30.0%
3/10 • Number of events 3 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
18.2%
2/11 • Number of events 4 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
33.3%
2/6 • Number of events 4 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
16.7%
1/6 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
33.3%
2/6 • Number of events 2 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
31.2%
5/16 • Number of events 6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
24.6%
15/61 • Number of events 20 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/11 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
16.7%
1/6 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/11 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
16.7%
1/6 • Number of events 2 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
16.7%
1/6 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
6.2%
1/16 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
4.9%
3/61 • Number of events 4 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Eye disorders
Dry eye
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/11 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
6.2%
1/16 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/11 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
16.7%
1/6 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
16.7%
1/6 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
3.3%
2/61 • Number of events 2 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
9.1%
1/11 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
16.7%
1/6 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
3.3%
2/61 • Number of events 2 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
9.1%
1/11 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/11 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
16.7%
1/6 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/11 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
16.7%
1/6 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
10.0%
1/10 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
18.2%
2/11 • Number of events 2 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
16.7%
1/6 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
16.7%
1/6 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
6.2%
1/16 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
9.8%
6/61 • Number of events 6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
18.2%
2/11 • Number of events 2 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
3.3%
2/61 • Number of events 2 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/11 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
16.7%
1/6 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
General disorders
Early satiety
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
9.1%
1/11 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
9.1%
1/11 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/11 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
16.7%
1/6 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Skin and subcutaneous tissue disorders
Erythema annulare
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
9.1%
1/11 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Injury, poisoning and procedural complications
Fall
|
10.0%
1/10 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/11 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
16.7%
1/6 • Number of events 2 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
16.7%
1/6 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
4.9%
3/61 • Number of events 4 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
General disorders
Fatigue
|
20.0%
2/10 • Number of events 2 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
36.4%
4/11 • Number of events 4 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
66.7%
4/6 • Number of events 4 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
33.3%
2/6 • Number of events 2 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
16.7%
1/6 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
50.0%
3/6 • Number of events 3 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
43.8%
7/16 • Number of events 8 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
37.7%
23/61 • Number of events 24 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
General disorders
Feeling jittery
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/11 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
16.7%
1/6 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Gastrointestinal disorders
Flatulence
|
10.0%
1/10 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/11 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
6.2%
1/16 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
3.3%
2/61 • Number of events 2 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/11 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
16.7%
1/6 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
9.1%
1/11 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Gastrointestinal disorders
Gastritis
|
10.0%
1/10 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
9.1%
1/11 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
3.3%
2/61 • Number of events 2 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
10.0%
1/10 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/11 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
16.7%
1/6 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
6.2%
1/16 • Number of events 2 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
4.9%
3/61 • Number of events 4 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
9.1%
1/11 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/11 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
16.7%
1/6 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Renal and urinary disorders
Haematuria
|
10.0%
1/10 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/11 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
16.7%
1/6 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
3.3%
2/61 • Number of events 2 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
10.0%
1/10 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/11 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Skin and subcutaneous tissue disorders
Hair colour changes
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
9.1%
1/11 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Nervous system disorders
Headache
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
9.1%
1/11 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
16.7%
1/6 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
16.7%
1/6 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
16.7%
1/6 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
12.5%
2/16 • Number of events 2 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
9.8%
6/61 • Number of events 6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Vascular disorders
Hot flush
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/11 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
6.2%
1/16 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/11 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
16.7%
1/6 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
9.1%
1/11 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/11 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
16.7%
1/6 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
10.0%
1/10 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/11 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/11 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
16.7%
1/6 • Number of events 2 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
1.6%
1/61 • Number of events 2 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
18.2%
2/11 • Number of events 2 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
33.3%
2/6 • Number of events 2 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
6.6%
4/61 • Number of events 4 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
9.1%
1/11 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
16.7%
1/6 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
16.7%
1/6 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
4.9%
3/61 • Number of events 3 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/11 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
16.7%
1/6 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/11 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
33.3%
2/6 • Number of events 2 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
33.3%
2/6 • Number of events 2 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
6.6%
4/61 • Number of events 4 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/11 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
16.7%
1/6 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Vascular disorders
Hypotension
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/11 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
16.7%
1/6 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
16.7%
1/6 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
16.7%
1/6 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
4.9%
3/61 • Number of events 3 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
9.1%
1/11 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
16.7%
1/6 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
3.3%
2/61 • Number of events 2 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Injury, poisoning and procedural complications
Incision site pain
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/11 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
6.2%
1/16 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
General disorders
Influenza like illness
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/11 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
50.0%
3/6 • Number of events 3 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
16.7%
1/6 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
6.6%
4/61 • Number of events 4 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
10.0%
1/10 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
18.2%
2/11 • Number of events 2 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
16.7%
1/6 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
6.6%
4/61 • Number of events 4 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
General disorders
Injection site reaction
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
9.1%
1/11 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/11 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
16.7%
1/6 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
6.2%
1/16 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
3.3%
2/61 • Number of events 2 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/11 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
16.7%
1/6 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
18.2%
2/11 • Number of events 2 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
6.2%
1/16 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
4.9%
3/61 • Number of events 3 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Skin and subcutaneous tissue disorders
Lichenoid keratosis
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/11 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
16.7%
1/6 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Investigations
Lipase increased
|
10.0%
1/10 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/11 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
16.7%
1/6 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
12.5%
2/16 • Number of events 4 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
6.6%
4/61 • Number of events 6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Investigations
Liver function test increased
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/11 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
16.7%
1/6 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Investigations
Low density lipoprotein increased
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
9.1%
1/11 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/11 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
6.2%
1/16 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/11 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
6.2%
1/16 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/11 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
16.7%
1/6 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/11 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
16.7%
1/6 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
10.0%
1/10 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/11 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
9.1%
1/11 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
6.2%
1/16 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
3.3%
2/61 • Number of events 2 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/11 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
16.7%
1/6 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
6.2%
1/16 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
3.3%
2/61 • Number of events 2 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
9.1%
1/11 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
18.2%
2/11 • Number of events 3 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
3.3%
2/61 • Number of events 3 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/11 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
16.7%
1/6 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Gastrointestinal disorders
Nausea
|
10.0%
1/10 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/11 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
16.7%
1/6 • Number of events 2 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
16.7%
1/6 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
16.7%
1/6 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
25.0%
4/16 • Number of events 6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
13.1%
8/61 • Number of events 11 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/11 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
16.7%
1/6 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Nervous system disorders
Neuropathy peripheral
|
10.0%
1/10 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
9.1%
1/11 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
16.7%
1/6 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
4.9%
3/61 • Number of events 3 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Blood and lymphatic system disorders
Neutropenia
|
10.0%
1/10 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/11 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/11 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
16.7%
1/6 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/11 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
16.7%
1/6 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
General disorders
Oedema peripheral
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/11 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
16.7%
1/6 • Number of events 2 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
1.6%
1/61 • Number of events 2 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
9.1%
1/11 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/11 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
16.7%
1/6 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Musculoskeletal and connective tissue disorders
Osteolysis
|
10.0%
1/10 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/11 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of jaw
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
9.1%
1/11 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
General disorders
Pain
|
20.0%
2/10 • Number of events 2 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/11 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
16.7%
1/6 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
4.9%
3/61 • Number of events 3 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
20.0%
2/10 • Number of events 2 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
9.1%
1/11 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
16.7%
1/6 • Number of events 2 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
6.2%
1/16 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
8.2%
5/61 • Number of events 6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
9.1%
1/11 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/11 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
6.2%
1/16 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Infections and infestations
Paronychia
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
9.1%
1/11 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
9.1%
1/11 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
General disorders
Peripheral swelling
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/11 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
16.7%
1/6 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Investigations
Platelet count decreased
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/11 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
6.2%
1/16 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/11 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
16.7%
1/6 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/11 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
16.7%
1/6 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
16.7%
1/6 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
6.2%
1/16 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
4.9%
3/61 • Number of events 3 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Metabolism and nutrition disorders
Polydipsia
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
9.1%
1/11 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
9.1%
1/11 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
9.1%
1/11 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/11 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
16.7%
1/6 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
20.0%
2/10 • Number of events 2 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/11 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
16.7%
1/6 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
33.3%
2/6 • Number of events 2 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
12.5%
2/16 • Number of events 2 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
11.5%
7/61 • Number of events 7 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/11 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
16.7%
1/6 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
General disorders
Pyrexia
|
10.0%
1/10 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
36.4%
4/11 • Number of events 5 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
16.7%
1/6 • Number of events 2 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
16.7%
1/6 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
12.5%
2/16 • Number of events 2 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
14.8%
9/61 • Number of events 11 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Injury, poisoning and procedural complications
Radiation associated pain
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
9.1%
1/11 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
9.1%
1/11 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
16.7%
1/6 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
6.2%
1/16 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
4.9%
3/61 • Number of events 3 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
9.1%
1/11 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
12.5%
2/16 • Number of events 2 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
4.9%
3/61 • Number of events 3 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
9.1%
1/11 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Infections and infestations
Rash pustular
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/11 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
16.7%
1/6 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/11 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
33.3%
2/6 • Number of events 2 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
3.3%
2/61 • Number of events 2 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
10.0%
1/10 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/11 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
9.1%
1/11 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/11 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
16.7%
1/6 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/11 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
16.7%
1/6 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
9.1%
1/11 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Blood and lymphatic system disorders
Splenic infarction
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/11 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
16.7%
1/6 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
9.1%
1/11 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
16.7%
1/6 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
16.7%
1/6 • Number of events 5 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
6.2%
1/16 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
6.6%
4/61 • Number of events 8 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
9.1%
1/11 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Endocrine disorders
Thyroiditis
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/11 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
16.7%
1/6 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
9.1%
1/11 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/11 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
16.7%
1/6 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
9.1%
1/11 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Nervous system disorders
Tremor
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
9.1%
1/11 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Investigations
Troponin increased
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/11 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
16.7%
1/6 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour associated fever
|
10.0%
1/10 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/11 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour flare
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
9.1%
1/11 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
20.0%
2/10 • Number of events 2 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
9.1%
1/11 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
16.7%
1/6 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
6.6%
4/61 • Number of events 4 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Infections and infestations
Upper respiratory tract infection
|
10.0%
1/10 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
9.1%
1/11 • Number of events 2 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
33.3%
2/6 • Number of events 2 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
6.2%
1/16 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
8.2%
5/61 • Number of events 6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Infections and infestations
Urinary tract infection
|
10.0%
1/10 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/11 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
16.7%
1/6 • Number of events 2 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
3.3%
2/61 • Number of events 3 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Renal and urinary disorders
Urine odour abnormal
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/11 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
6.2%
1/16 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/11 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
16.7%
1/6 • Number of events 2 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
1.6%
1/61 • Number of events 2 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
10.0%
1/10 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/11 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Skin and subcutaneous tissue disorders
Vancomycin infusion reaction
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/11 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
16.7%
1/6 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
9.1%
1/11 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Eye disorders
Vision blurred
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/11 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
16.7%
1/6 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Skin and subcutaneous tissue disorders
Vitiligo
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
9.1%
1/11 • Number of events 2 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
1.6%
1/61 • Number of events 2 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
18.2%
2/11 • Number of events 3 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
16.7%
1/6 • Number of events 3 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
33.3%
2/6 • Number of events 2 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
6.2%
1/16 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
9.8%
6/61 • Number of events 9 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Reproductive system and breast disorders
Vulvovaginal burning sensation
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
9.1%
1/11 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Infections and infestations
Vulvovaginitis
|
10.0%
1/10 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/11 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Investigations
Weight decreased
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/11 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
16.7%
1/6 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
16.7%
1/6 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
3.3%
2/61 • Number of events 2 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
|
Investigations
Weight increased
|
0.00%
0/10 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/11 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
16.7%
1/6 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/6 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
0.00%
0/16 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
1.6%
1/61 • Number of events 1 • up to approximately 5 years
For Part 1, AEs are reported for the Full Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of assigned study treatment. For Part 2, AEs are reported for the RECIST Evaluable Analysis Set, comprised of all participants enrolled in the study who received at least 1 dose of study treatment and completed a baseline scan and met specified criteria.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Following the first publication, the Institution and/or Principal Investigator may publish data or results from the Study, provided, however, that the Institution and/or Principal Investigator submits the proposed publication to the Sponsor for review at least sixty (60) days prior to the date of the proposed publication. Sponsor may remove from the proposed publication any information that is considered confidential and/or proprietary other than Study data and results.
- Publication restrictions are in place
Restriction type: OTHER