Trial Outcomes & Findings for A Study of Nanrilkefusp Alfa (SOT101) in Combination With Cetuximab to Evaluate the Efficacy and Safety in Patients With Colorectal Cancer (NCT NCT05619172)
NCT ID: NCT05619172
Last Updated: 2025-07-24
Results Overview
Objective response rate according to RECIST 1.1 was defined as the proportion of participants with complete response according to RECIST 1.1 or partial response according to RECIST 1.1 for target lesions and assessed by CT/MRI. Participants with missing data were considered non-responders.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
16 participants
Primary outcome timeframe
Day 1 up to approximately 1 year 2 months
Results posted on
2025-07-24
Participant Flow
Participant milestones
| Measure |
Nanrilkefusp Alfa 9 µg/kg and Cetuximab
Participants were treated with 9 µg/kg of nanrilkefusp alfa in combination with cetuximab. Nanrilkefusp alfa treatment was administered on day 1 (from cycle 2 onwards, ±1 day), day 2 (±1 day), day 8 (±1 day), and day 9 (±1 day) of each 21-day cycle. Cetuximab treatment was administered on day 1 (from cycle 2 onwards, ±1 day), day 8 (±1 day), and day 15 (±1 day) of each 21-day cycle; on day 1 and day 8, cetuximab infusion started within 30 minutes after nanrilkefusp alfa administration.
|
Nanrilkefusp Alfa 12 µg/kg and Cetuximab
Participants were treated with 12 µg/kg of nanrilkefusp alfa in combination with cetuximab. Nanrilkefusp alfa treatment was administered on day 1 (from cycle 2 onwards, ±1 day), day 2 (±1 day), day 8 (±1 day), and day 9 (±1 day) of each 21-day cycle. Cetuximab treatment was administered on day 1 (from cycle 2 onwards, ±1 day), day 8 (±1 day), and day 15 (±1 day) of each 21-day cycle; on day 1 and day 8, cetuximab infusion started within 30 minutes after nanrilkefusp alfa administration.
|
|---|---|---|
|
Safety Cohort 1
STARTED
|
14
|
0
|
|
Safety Cohort 1
COMPLETED
|
0
|
0
|
|
Safety Cohort 1
NOT COMPLETED
|
14
|
0
|
|
Safety Cohort 2
STARTED
|
0
|
2
|
|
Safety Cohort 2
COMPLETED
|
0
|
0
|
|
Safety Cohort 2
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
Nanrilkefusp Alfa 9 µg/kg and Cetuximab
Participants were treated with 9 µg/kg of nanrilkefusp alfa in combination with cetuximab. Nanrilkefusp alfa treatment was administered on day 1 (from cycle 2 onwards, ±1 day), day 2 (±1 day), day 8 (±1 day), and day 9 (±1 day) of each 21-day cycle. Cetuximab treatment was administered on day 1 (from cycle 2 onwards, ±1 day), day 8 (±1 day), and day 15 (±1 day) of each 21-day cycle; on day 1 and day 8, cetuximab infusion started within 30 minutes after nanrilkefusp alfa administration.
|
Nanrilkefusp Alfa 12 µg/kg and Cetuximab
Participants were treated with 12 µg/kg of nanrilkefusp alfa in combination with cetuximab. Nanrilkefusp alfa treatment was administered on day 1 (from cycle 2 onwards, ±1 day), day 2 (±1 day), day 8 (±1 day), and day 9 (±1 day) of each 21-day cycle. Cetuximab treatment was administered on day 1 (from cycle 2 onwards, ±1 day), day 8 (±1 day), and day 15 (±1 day) of each 21-day cycle; on day 1 and day 8, cetuximab infusion started within 30 minutes after nanrilkefusp alfa administration.
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|---|---|---|
|
Safety Cohort 1
Death
|
7
|
0
|
|
Safety Cohort 1
Study terminated by sponsor
|
7
|
0
|
|
Safety Cohort 2
Death
|
0
|
1
|
|
Safety Cohort 2
Study terminated by sponsor
|
0
|
1
|
Baseline Characteristics
A Study of Nanrilkefusp Alfa (SOT101) in Combination With Cetuximab to Evaluate the Efficacy and Safety in Patients With Colorectal Cancer
Baseline characteristics by cohort
| Measure |
Nanrilkefusp Alfa and Cetuximab
n=16 Participants
Participants were treated with nanrilkefusp alfa (safety cohort 1: 14 participants with 9 µg/kg nanrilkefusp alfa; safety cohort 2: 2 participants with 12 µg/kg nanrilkefusp alfa) in combination with cetuximab. Per statistical considerations outlined in the trial Protocol and Statistical Analysis Plan, all patients were analyzed within pre-specified populations across the entire trial. There was no plan to analyze cohorts separately; therefore, results are presented in aggregate. The trial was a single-arm design, not a classic dose-escalation study, as the RP2D (12 µg/kg) had been established in a prior trial (NCT04234113). The 9 µg/kg dose was a safety cohort allowing one-way crossover to 12 µg/kg.
Nanrilkefusp alfa treatment was administered on day 1 (from cycle 2 onwards, ±1 day), day 2 (±1 day), day 8 (±1 day), and day 9 (±1 day) of each 21-day cycle. Cetuximab treatment was administered on day 1 (from cycle 2 onwards, ±1 day), day 8 (±1 day), and day 15 (±1 day) of each 21-day cycle; on day 1 and day 8, cetuximab infusion started within 30 minutes after nanrilkefusp alfa administration.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=39 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=39 Participants
|
|
Age, Continuous
|
60 years
n=39 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=39 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=39 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=39 Participants
|
|
Region of Enrollment
Belgium
|
7 participants
n=39 Participants
|
|
Region of Enrollment
France
|
3 participants
n=39 Participants
|
|
Region of Enrollment
Spain
|
6 participants
n=39 Participants
|
PRIMARY outcome
Timeframe: Day 1 up to approximately 1 year 2 monthsPopulation: Per statistical considerations outlined in the trial Protocol and Statistical Analysis Plan, all patients were analyzed within pre-specified populations across the entire trial. There was no plan to analyze cohorts separately; therefore, results are presented in aggregate. The trial was a single-arm design, not a classic dose-escalation study, as the RP2D (12 µg/kg) had been established in a prior trial (NCT04234113). The 9 µg/kg dose was a safety cohort allowing one-way crossover to 12 µg/kg.
Objective response rate according to RECIST 1.1 was defined as the proportion of participants with complete response according to RECIST 1.1 or partial response according to RECIST 1.1 for target lesions and assessed by CT/MRI. Participants with missing data were considered non-responders.
Outcome measures
| Measure |
Nanrilkefusp Alfa and Cetuximab
n=16 Participants
Participants were treated with nanrilkefusp alfa in combination with cetuximab. Safety cohort 1: 14 participants were treated with 9 µg/kg nanrilkefusp alfa; safety cohort 2: 2 participants were treated with 12 µg/kg nanrilkefusp alfa. Nanrilkefusp alfa treatment was administered on day 1 (from cycle 2 onwards, ±1 day), day 2 (±1 day), day 8 (±1 day), and day 9 (±1 day) of each 21-day cycle. Cetuximab treatment was administered on day 1 (from cycle 2 onwards, ±1 day), day 8 (±1 day), and day 15 (±1 day) of each 21-day cycle; on day 1 and day 8, cetuximab infusion started within 30 minutes after nanrilkefusp alfa administration.
|
|---|---|
|
Objective Response Rate According to Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1)
|
0 percentage of participants
Interval 0.0 to 20.591
|
SECONDARY outcome
Timeframe: Day 1 up to approximately 1 year 5 monthsPopulation: Per statistical considerations outlined in the trial Protocol and Statistical Analysis Plan, all patients were analyzed within pre-specified populations across the entire trial. There was no plan to analyze cohorts separately; therefore, results are presented in aggregate. The trial was a single-arm design, not a classic dose-escalation study, as the RP2D (12 µg/kg) had been established in a prior trial (NCT04234113). The 9 µg/kg dose was a safety cohort allowing one-way crossover to 12 µg/kg.
Objective response rate according to iRECIST was defined as the proportion of participants with complete response according to iRECIST or partial response according to iRECIST for target lesions and assessed by CT/MRI. Participants with missing data were considered non-responders.
Outcome measures
| Measure |
Nanrilkefusp Alfa and Cetuximab
n=16 Participants
Participants were treated with nanrilkefusp alfa in combination with cetuximab. Safety cohort 1: 14 participants were treated with 9 µg/kg nanrilkefusp alfa; safety cohort 2: 2 participants were treated with 12 µg/kg nanrilkefusp alfa. Nanrilkefusp alfa treatment was administered on day 1 (from cycle 2 onwards, ±1 day), day 2 (±1 day), day 8 (±1 day), and day 9 (±1 day) of each 21-day cycle. Cetuximab treatment was administered on day 1 (from cycle 2 onwards, ±1 day), day 8 (±1 day), and day 15 (±1 day) of each 21-day cycle; on day 1 and day 8, cetuximab infusion started within 30 minutes after nanrilkefusp alfa administration.
|
|---|---|
|
Objective Response Rate According to RECIST for Immune-based Therapeutics (iRECIST)
|
0 percentage of participants
Interval 0.0 to 20.591
|
SECONDARY outcome
Timeframe: Day 1 up to approximately 1 year 5 monthsPopulation: Per statistical considerations outlined in the trial Protocol and Statistical Analysis Plan, all patients were analyzed within pre-specified populations across the entire trial. There was no plan to analyze cohorts separately; therefore, results are presented in aggregate. The trial was a single-arm design, not a classic dose-escalation study, as the RP2D (12 µg/kg) had been established in a prior trial (NCT04234113). The 9 µg/kg dose was a safety cohort allowing one-way crossover to 12 µg/kg.
The best overall response according to RECIST 1.1 was defined as the best response from the start of study treatment until the first documented disease progression, death, or start of new anti-cancer therapy for target lesions and assessed by CT/MRI.
Outcome measures
| Measure |
Nanrilkefusp Alfa and Cetuximab
n=16 Participants
Participants were treated with nanrilkefusp alfa in combination with cetuximab. Safety cohort 1: 14 participants were treated with 9 µg/kg nanrilkefusp alfa; safety cohort 2: 2 participants were treated with 12 µg/kg nanrilkefusp alfa. Nanrilkefusp alfa treatment was administered on day 1 (from cycle 2 onwards, ±1 day), day 2 (±1 day), day 8 (±1 day), and day 9 (±1 day) of each 21-day cycle. Cetuximab treatment was administered on day 1 (from cycle 2 onwards, ±1 day), day 8 (±1 day), and day 15 (±1 day) of each 21-day cycle; on day 1 and day 8, cetuximab infusion started within 30 minutes after nanrilkefusp alfa administration.
|
|---|---|
|
Best Overall Response According to RECIST 1.1: Number of Participants With Complete Response
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 up to approximately 1 year 5 monthsPopulation: Per statistical considerations outlined in the trial Protocol and Statistical Analysis Plan, all patients were analyzed within pre-specified populations across the entire trial. There was no plan to analyze cohorts separately; therefore, results are presented in aggregate. The trial was a single-arm design, not a classic dose-escalation study, as the RP2D (12 µg/kg) had been established in a prior trial (NCT04234113). The 9 µg/kg dose was a safety cohort allowing one-way crossover to 12 µg/kg.
The best overall response according to RECIST 1.1 was defined as the best response from the start of study treatment until the first documented disease progression, death, or start of new anti-cancer therapy for target lesions and assessed by CT/MRI.
Outcome measures
| Measure |
Nanrilkefusp Alfa and Cetuximab
n=16 Participants
Participants were treated with nanrilkefusp alfa in combination with cetuximab. Safety cohort 1: 14 participants were treated with 9 µg/kg nanrilkefusp alfa; safety cohort 2: 2 participants were treated with 12 µg/kg nanrilkefusp alfa. Nanrilkefusp alfa treatment was administered on day 1 (from cycle 2 onwards, ±1 day), day 2 (±1 day), day 8 (±1 day), and day 9 (±1 day) of each 21-day cycle. Cetuximab treatment was administered on day 1 (from cycle 2 onwards, ±1 day), day 8 (±1 day), and day 15 (±1 day) of each 21-day cycle; on day 1 and day 8, cetuximab infusion started within 30 minutes after nanrilkefusp alfa administration.
|
|---|---|
|
Best Overall Response According to RECIST 1.1: Number of Participants With Partial Response
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 up to approximately 1 year 5 monthsPopulation: Per statistical considerations outlined in the trial Protocol and Statistical Analysis Plan, all patients were analyzed within pre-specified populations across the entire trial. There was no plan to analyze cohorts separately; therefore, results are presented in aggregate. The trial was a single-arm design, not a classic dose-escalation study, as the RP2D (12 µg/kg) had been established in a prior trial (NCT04234113). The 9 µg/kg dose was a safety cohort allowing one-way crossover to 12 µg/kg.
The best overall response according to RECIST 1.1 was defined as the best response from the start of study treatment until the first documented disease progression, death, or start of new anti-cancer therapy for target lesions and assessed by CT/MRI. Stable disease according to RECIST 1.1 had to last at least 6 weeks from the start of study treatment. If not, at least 1 follow-up scan was required to declare stable disease.
Outcome measures
| Measure |
Nanrilkefusp Alfa and Cetuximab
n=16 Participants
Participants were treated with nanrilkefusp alfa in combination with cetuximab. Safety cohort 1: 14 participants were treated with 9 µg/kg nanrilkefusp alfa; safety cohort 2: 2 participants were treated with 12 µg/kg nanrilkefusp alfa. Nanrilkefusp alfa treatment was administered on day 1 (from cycle 2 onwards, ±1 day), day 2 (±1 day), day 8 (±1 day), and day 9 (±1 day) of each 21-day cycle. Cetuximab treatment was administered on day 1 (from cycle 2 onwards, ±1 day), day 8 (±1 day), and day 15 (±1 day) of each 21-day cycle; on day 1 and day 8, cetuximab infusion started within 30 minutes after nanrilkefusp alfa administration.
|
|---|---|
|
Best Overall Response According to RECIST 1.1: Number of Participants With Stable Disease
|
6 Participants
|
SECONDARY outcome
Timeframe: Day 1 up to approximately 1 year 5 monthsPopulation: Per statistical considerations outlined in the trial Protocol and Statistical Analysis Plan, all patients were analyzed within pre-specified populations across the entire trial. There was no plan to analyze cohorts separately; therefore, results are presented in aggregate. The trial was a single-arm design, not a classic dose-escalation study, as the RP2D (12 µg/kg) had been established in a prior trial (NCT04234113). The 9 µg/kg dose was a safety cohort allowing one-way crossover to 12 µg/kg.
The best overall response according to RECIST 1.1 was defined as the best response from the start of study treatment until the first documented disease progression, death, or start of new anti-cancer therapy for target lesions and assessed by CT/MRI.
Outcome measures
| Measure |
Nanrilkefusp Alfa and Cetuximab
n=16 Participants
Participants were treated with nanrilkefusp alfa in combination with cetuximab. Safety cohort 1: 14 participants were treated with 9 µg/kg nanrilkefusp alfa; safety cohort 2: 2 participants were treated with 12 µg/kg nanrilkefusp alfa. Nanrilkefusp alfa treatment was administered on day 1 (from cycle 2 onwards, ±1 day), day 2 (±1 day), day 8 (±1 day), and day 9 (±1 day) of each 21-day cycle. Cetuximab treatment was administered on day 1 (from cycle 2 onwards, ±1 day), day 8 (±1 day), and day 15 (±1 day) of each 21-day cycle; on day 1 and day 8, cetuximab infusion started within 30 minutes after nanrilkefusp alfa administration.
|
|---|---|
|
Best Overall Response According to RECIST 1.1: Number of Participants With Progressive Disease
|
7 Participants
|
SECONDARY outcome
Timeframe: Day 1 up to approximately 1 year 5 monthsPopulation: Per statistical considerations outlined in the trial Protocol and Statistical Analysis Plan, all patients were analyzed within pre-specified populations across the entire trial. There was no plan to analyze cohorts separately; therefore, results are presented in aggregate. The trial was a single-arm design, not a classic dose-escalation study, as the RP2D (12 µg/kg) had been established in a prior trial (NCT04234113). The 9 µg/kg dose was a safety cohort allowing one-way crossover to 12 µg/kg.
The best overall response according to iRECIST was defined as the best response from the start of study treatment until the first documented disease progression, death, or start of new anti-cancer therapy for target lesions and assessed by CT/MRI.
Outcome measures
| Measure |
Nanrilkefusp Alfa and Cetuximab
n=16 Participants
Participants were treated with nanrilkefusp alfa in combination with cetuximab. Safety cohort 1: 14 participants were treated with 9 µg/kg nanrilkefusp alfa; safety cohort 2: 2 participants were treated with 12 µg/kg nanrilkefusp alfa. Nanrilkefusp alfa treatment was administered on day 1 (from cycle 2 onwards, ±1 day), day 2 (±1 day), day 8 (±1 day), and day 9 (±1 day) of each 21-day cycle. Cetuximab treatment was administered on day 1 (from cycle 2 onwards, ±1 day), day 8 (±1 day), and day 15 (±1 day) of each 21-day cycle; on day 1 and day 8, cetuximab infusion started within 30 minutes after nanrilkefusp alfa administration.
|
|---|---|
|
Best Overall Response According to iRECIST: Number of Participants With Complete Response
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 up to approximately 1 year 5 monthsPopulation: Per statistical considerations outlined in the trial Protocol and Statistical Analysis Plan, all patients were analyzed within pre-specified populations across the entire trial. There was no plan to analyze cohorts separately; therefore, results are presented in aggregate. The trial was a single-arm design, not a classic dose-escalation study, as the RP2D (12 µg/kg) had been established in a prior trial (NCT04234113). The 9 µg/kg dose was a safety cohort allowing one-way crossover to 12 µg/kg.
The best overall response according to iRECIST was defined as the best response from the start of study treatment until the first documented disease progression, death, or start of new anti-cancer therapy for target lesions and assessed by CT/MRI.
Outcome measures
| Measure |
Nanrilkefusp Alfa and Cetuximab
n=16 Participants
Participants were treated with nanrilkefusp alfa in combination with cetuximab. Safety cohort 1: 14 participants were treated with 9 µg/kg nanrilkefusp alfa; safety cohort 2: 2 participants were treated with 12 µg/kg nanrilkefusp alfa. Nanrilkefusp alfa treatment was administered on day 1 (from cycle 2 onwards, ±1 day), day 2 (±1 day), day 8 (±1 day), and day 9 (±1 day) of each 21-day cycle. Cetuximab treatment was administered on day 1 (from cycle 2 onwards, ±1 day), day 8 (±1 day), and day 15 (±1 day) of each 21-day cycle; on day 1 and day 8, cetuximab infusion started within 30 minutes after nanrilkefusp alfa administration.
|
|---|---|
|
Best Overall Response According to iRECIST: Number of Participants With Partial Response
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 up to approximately 1 year 5 monthsPopulation: Per statistical considerations outlined in the trial Protocol and Statistical Analysis Plan, all patients were analyzed within pre-specified populations across the entire trial. There was no plan to analyze cohorts separately; therefore, results are presented in aggregate. The trial was a single-arm design, not a classic dose-escalation study, as the RP2D (12 µg/kg) had been established in a prior trial (NCT04234113). The 9 µg/kg dose was a safety cohort allowing one-way crossover to 12 µg/kg.
The best overall response according to iRECIST was defined as the best response from the start of study treatment until the first documented disease progression, death, or start of new anti-cancer therapy for target lesions and assessed by CT/MRI. Stable disease according to iRECIST had to last at least 6 weeks from the start of study treatment. If not, at least 1 follow-up scan was required to declare stable disease.
Outcome measures
| Measure |
Nanrilkefusp Alfa and Cetuximab
n=16 Participants
Participants were treated with nanrilkefusp alfa in combination with cetuximab. Safety cohort 1: 14 participants were treated with 9 µg/kg nanrilkefusp alfa; safety cohort 2: 2 participants were treated with 12 µg/kg nanrilkefusp alfa. Nanrilkefusp alfa treatment was administered on day 1 (from cycle 2 onwards, ±1 day), day 2 (±1 day), day 8 (±1 day), and day 9 (±1 day) of each 21-day cycle. Cetuximab treatment was administered on day 1 (from cycle 2 onwards, ±1 day), day 8 (±1 day), and day 15 (±1 day) of each 21-day cycle; on day 1 and day 8, cetuximab infusion started within 30 minutes after nanrilkefusp alfa administration.
|
|---|---|
|
Best Overall Response According to iRECIST: Number of Participants With Stable Disease
|
6 Participants
|
SECONDARY outcome
Timeframe: Day 1 up to approximately 1 year 5 monthsPopulation: Per statistical considerations outlined in the trial Protocol and Statistical Analysis Plan, all patients were analyzed within pre-specified populations across the entire trial. There was no plan to analyze cohorts separately; therefore, results are presented in aggregate. The trial was a single-arm design, not a classic dose-escalation study, as the RP2D (12 µg/kg) had been established in a prior trial (NCT04234113). The 9 µg/kg dose was a safety cohort allowing one-way crossover to 12 µg/kg.
The best overall response according to iRECIST was defined as the best response from the start of study treatment until the first documented disease progression, death, or start of new anti-cancer therapy for target lesions and assessed by CT/MRI.
Outcome measures
| Measure |
Nanrilkefusp Alfa and Cetuximab
n=16 Participants
Participants were treated with nanrilkefusp alfa in combination with cetuximab. Safety cohort 1: 14 participants were treated with 9 µg/kg nanrilkefusp alfa; safety cohort 2: 2 participants were treated with 12 µg/kg nanrilkefusp alfa. Nanrilkefusp alfa treatment was administered on day 1 (from cycle 2 onwards, ±1 day), day 2 (±1 day), day 8 (±1 day), and day 9 (±1 day) of each 21-day cycle. Cetuximab treatment was administered on day 1 (from cycle 2 onwards, ±1 day), day 8 (±1 day), and day 15 (±1 day) of each 21-day cycle; on day 1 and day 8, cetuximab infusion started within 30 minutes after nanrilkefusp alfa administration.
|
|---|---|
|
Best Overall Response According to iRECIST: Number of Participants With Unconfirmed Progressive Disease
|
5 Participants
|
SECONDARY outcome
Timeframe: Day 1 up to approximately 1 year 5 monthsPopulation: Per statistical considerations outlined in the trial Protocol and Statistical Analysis Plan, all patients were analyzed within pre-specified populations across the entire trial. There was no plan to analyze cohorts separately; therefore, results are presented in aggregate. The trial was a single-arm design, not a classic dose-escalation study, as the RP2D (12 µg/kg) had been established in a prior trial (NCT04234113). The 9 µg/kg dose was a safety cohort allowing one-way crossover to 12 µg/kg.
The best overall response according to iRECIST was defined as the best response from the start of study treatment until the first documented disease progression, death, or start of new anti-cancer therapy for target lesions and assessed by CT/MRI.
Outcome measures
| Measure |
Nanrilkefusp Alfa and Cetuximab
n=16 Participants
Participants were treated with nanrilkefusp alfa in combination with cetuximab. Safety cohort 1: 14 participants were treated with 9 µg/kg nanrilkefusp alfa; safety cohort 2: 2 participants were treated with 12 µg/kg nanrilkefusp alfa. Nanrilkefusp alfa treatment was administered on day 1 (from cycle 2 onwards, ±1 day), day 2 (±1 day), day 8 (±1 day), and day 9 (±1 day) of each 21-day cycle. Cetuximab treatment was administered on day 1 (from cycle 2 onwards, ±1 day), day 8 (±1 day), and day 15 (±1 day) of each 21-day cycle; on day 1 and day 8, cetuximab infusion started within 30 minutes after nanrilkefusp alfa administration.
|
|---|---|
|
Best Overall Response According to iRECIST: Number of Participants With Confirmed Progressive Disease
|
2 Participants
|
SECONDARY outcome
Timeframe: Day 1 up to approximately 1 year 5 monthsPopulation: As outlined in the trial Protocol and Statistical Analysis Plan, patients were analyzed within pre-specified populations across the trial. There was no plan to analyze cohorts separately; results are presented in aggregate. The trial was a single-arm design, not a dose-escalation study; the RP2D (12 µg/kg) was established in a prior trial (NCT04234113). The 9 µg/kg dose was a safety cohort with one-way crossover to 12 µg/kg. No participant had a PR or CR per RECIST; DoR data were not collected.
Duration of response according to RECIST 1.1 was defined as time to disease progression for participants with partial response or complete response according to RECIST 1.1.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1 up to approximately 1 year 5 monthsPopulation: As outlined in the trial Protocol and Statistical Analysis Plan, patients were analyzed within pre-specified populations across the trial. There was no plan to analyze cohorts separately; results are presented in aggregate. The trial was a single-arm design, not a dose-escalation study; the RP2D (12 µg/kg) was established in a prior trial (NCT04234113). The 9 µg/kg dose was a safety cohort with one-way crossover to 12 µg/kg. No participant had a PR or CR per iRECIST; DoR data were not collected
Duration of response according to iRECIST was defined as time to disease progression for participants with partial response or complete response according to iRECIST.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1 up to approximately 1 year 5 monthsPopulation: Per statistical considerations outlined in the trial Protocol and Statistical Analysis Plan, all patients were analyzed within pre-specified populations across the entire trial. There was no plan to analyze cohorts separately; therefore, results are presented in aggregate. The trial was a single-arm design, not a classic dose-escalation study, as the RP2D (12 µg/kg) had been established in a prior trial (NCT04234113). The 9 µg/kg dose was a safety cohort allowing one-way crossover to 12 µg/kg.
Clinical benefit rate according to RECIST 1.1 was defined as the number of partial responses, complete responses, and stable disease according to RECIST 1.1. Stable disease had to last at least 6 weeks from the start of study treatment. If not, at least 1 follow-up scan was required to declare stable disease. Participants with missing data were considered non-responders.
Outcome measures
| Measure |
Nanrilkefusp Alfa and Cetuximab
n=16 Participants
Participants were treated with nanrilkefusp alfa in combination with cetuximab. Safety cohort 1: 14 participants were treated with 9 µg/kg nanrilkefusp alfa; safety cohort 2: 2 participants were treated with 12 µg/kg nanrilkefusp alfa. Nanrilkefusp alfa treatment was administered on day 1 (from cycle 2 onwards, ±1 day), day 2 (±1 day), day 8 (±1 day), and day 9 (±1 day) of each 21-day cycle. Cetuximab treatment was administered on day 1 (from cycle 2 onwards, ±1 day), day 8 (±1 day), and day 15 (±1 day) of each 21-day cycle; on day 1 and day 8, cetuximab infusion started within 30 minutes after nanrilkefusp alfa administration.
|
|---|---|
|
Clinical Benefit Rate According to RECIST 1.1
|
37.5 percentage of participants
Interval 15.198 to 64.565
|
SECONDARY outcome
Timeframe: Day 1 up to approximately 1 year 5 monthsPopulation: Per statistical considerations outlined in the trial Protocol and Statistical Analysis Plan, all patients were analyzed within pre-specified populations across the entire trial. There was no plan to analyze cohorts separately; therefore, results are presented in aggregate. The trial was a single-arm design, not a classic dose-escalation study, as the RP2D (12 µg/kg) had been established in a prior trial (NCT04234113). The 9 µg/kg dose was a safety cohort allowing one-way crossover to 12 µg/kg.
Clinical benefit rate according to iRECIST was defined as the number of partial responses, complete responses, and stable disease according to iRECIST. Stable disease had to last at least 6 weeks from the start of study treatment. If not, at least 1 follow-up scan was required to declare stable disease. Participants with missing data were considered non-responders.
Outcome measures
| Measure |
Nanrilkefusp Alfa and Cetuximab
n=16 Participants
Participants were treated with nanrilkefusp alfa in combination with cetuximab. Safety cohort 1: 14 participants were treated with 9 µg/kg nanrilkefusp alfa; safety cohort 2: 2 participants were treated with 12 µg/kg nanrilkefusp alfa. Nanrilkefusp alfa treatment was administered on day 1 (from cycle 2 onwards, ±1 day), day 2 (±1 day), day 8 (±1 day), and day 9 (±1 day) of each 21-day cycle. Cetuximab treatment was administered on day 1 (from cycle 2 onwards, ±1 day), day 8 (±1 day), and day 15 (±1 day) of each 21-day cycle; on day 1 and day 8, cetuximab infusion started within 30 minutes after nanrilkefusp alfa administration.
|
|---|---|
|
Clinical Benefit Rate According to iRECIST
|
37.5 percentage of participants
Interval 15.198 to 64.565
|
SECONDARY outcome
Timeframe: Day 1 up to approximately 1 year 5 monthsPopulation: Per statistical considerations outlined in the trial Protocol and Statistical Analysis Plan, all patients were analyzed within pre-specified populations across the entire trial. There was no plan to analyze cohorts separately; therefore, results are presented in aggregate. The trial was a single-arm design, not a classic dose-escalation study, as the RP2D (12 µg/kg) had been established in a prior trial (NCT04234113). The 9 µg/kg dose was a safety cohort allowing one-way crossover to 12 µg/kg.
Progression-free survival according to RECIST 1.1 was defined as the time from the first day of study treatment to the first date of radiological disease progression according to RECIST 1.1 or death.
Outcome measures
| Measure |
Nanrilkefusp Alfa and Cetuximab
n=16 Participants
Participants were treated with nanrilkefusp alfa in combination with cetuximab. Safety cohort 1: 14 participants were treated with 9 µg/kg nanrilkefusp alfa; safety cohort 2: 2 participants were treated with 12 µg/kg nanrilkefusp alfa. Nanrilkefusp alfa treatment was administered on day 1 (from cycle 2 onwards, ±1 day), day 2 (±1 day), day 8 (±1 day), and day 9 (±1 day) of each 21-day cycle. Cetuximab treatment was administered on day 1 (from cycle 2 onwards, ±1 day), day 8 (±1 day), and day 15 (±1 day) of each 21-day cycle; on day 1 and day 8, cetuximab infusion started within 30 minutes after nanrilkefusp alfa administration.
|
|---|---|
|
Progression-free Survival According to RECIST 1.1
|
2.7 months
Interval 1.05 to 3.94
|
SECONDARY outcome
Timeframe: Day 1 up to approximately 1 year 5 monthsPopulation: Per statistical considerations outlined in the trial Protocol and Statistical Analysis Plan, all patients were analyzed within pre-specified populations across the entire trial. There was no plan to analyze cohorts separately; therefore, results are presented in aggregate. The trial was a single-arm design, not a classic dose-escalation study, as the RP2D (12 µg/kg) had been established in a prior trial (NCT04234113). The 9 µg/kg dose was a safety cohort allowing one-way crossover to 12 µg/kg.
Progression-free survival according to iRECIST was defined as the time from the first day of study treatment to the first date of radiological disease progression according to iRECIST or death.
Outcome measures
| Measure |
Nanrilkefusp Alfa and Cetuximab
n=16 Participants
Participants were treated with nanrilkefusp alfa in combination with cetuximab. Safety cohort 1: 14 participants were treated with 9 µg/kg nanrilkefusp alfa; safety cohort 2: 2 participants were treated with 12 µg/kg nanrilkefusp alfa. Nanrilkefusp alfa treatment was administered on day 1 (from cycle 2 onwards, ±1 day), day 2 (±1 day), day 8 (±1 day), and day 9 (±1 day) of each 21-day cycle. Cetuximab treatment was administered on day 1 (from cycle 2 onwards, ±1 day), day 8 (±1 day), and day 15 (±1 day) of each 21-day cycle; on day 1 and day 8, cetuximab infusion started within 30 minutes after nanrilkefusp alfa administration.
|
|---|---|
|
Progression-free Survival According to iRECIST
|
2.7 months
Interval 1.05 to 3.94
|
SECONDARY outcome
Timeframe: Day 1 up to approximately 1 year 5 monthsPopulation: Per statistical considerations outlined in the trial Protocol and Statistical Analysis Plan, all patients were analyzed within pre-specified populations across the entire trial. There was no plan to analyze cohorts separately; therefore, results are presented in aggregate. The trial was a single-arm design, not a classic dose-escalation study, as the RP2D (12 µg/kg) had been established in a prior trial (NCT04234113). The 9 µg/kg dose was a safety cohort allowing one-way crossover to 12 µg/kg.
Time to response according to RECIST 1.1 was defined as the time from the first day of study treatment to the first date of partial response or complete response according to RECIST 1.1. Participants with missing data were censored at the last assessment date, date of death, or date of eligibility (for incomplete or missing baseline tumor assessments), whichever occurred last.
Outcome measures
| Measure |
Nanrilkefusp Alfa and Cetuximab
n=16 Participants
Participants were treated with nanrilkefusp alfa in combination with cetuximab. Safety cohort 1: 14 participants were treated with 9 µg/kg nanrilkefusp alfa; safety cohort 2: 2 participants were treated with 12 µg/kg nanrilkefusp alfa. Nanrilkefusp alfa treatment was administered on day 1 (from cycle 2 onwards, ±1 day), day 2 (±1 day), day 8 (±1 day), and day 9 (±1 day) of each 21-day cycle. Cetuximab treatment was administered on day 1 (from cycle 2 onwards, ±1 day), day 8 (±1 day), and day 15 (±1 day) of each 21-day cycle; on day 1 and day 8, cetuximab infusion started within 30 minutes after nanrilkefusp alfa administration.
|
|---|---|
|
Time to Response According to RECIST 1.1
|
0 months
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Day 1 up to approximately 1 year 5 monthsPopulation: Per statistical considerations outlined in the trial Protocol and Statistical Analysis Plan, all patients were analyzed within pre-specified populations across the entire trial. There was no plan to analyze cohorts separately; therefore, results are presented in aggregate. The trial was a single-arm design, not a classic dose-escalation study, as the RP2D (12 µg/kg) had been established in a prior trial (NCT04234113). The 9 µg/kg dose was a safety cohort allowing one-way crossover to 12 µg/kg.
Time to response according to iRECIST was defined as the time from the first day of study treatment to the first date of partial response or complete response according to iRECIST. Participants with missing data were censored at the last assessment date, date of death, or date of eligibility (for incomplete or missing baseline tumor assessments), whichever occurred last.
Outcome measures
| Measure |
Nanrilkefusp Alfa and Cetuximab
n=16 Participants
Participants were treated with nanrilkefusp alfa in combination with cetuximab. Safety cohort 1: 14 participants were treated with 9 µg/kg nanrilkefusp alfa; safety cohort 2: 2 participants were treated with 12 µg/kg nanrilkefusp alfa. Nanrilkefusp alfa treatment was administered on day 1 (from cycle 2 onwards, ±1 day), day 2 (±1 day), day 8 (±1 day), and day 9 (±1 day) of each 21-day cycle. Cetuximab treatment was administered on day 1 (from cycle 2 onwards, ±1 day), day 8 (±1 day), and day 15 (±1 day) of each 21-day cycle; on day 1 and day 8, cetuximab infusion started within 30 minutes after nanrilkefusp alfa administration.
|
|---|---|
|
Time to Response According to iRECIST
|
0 months
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Day 1 up to approximately 1 year 5 monthsPopulation: Per statistical considerations outlined in the trial Protocol and Statistical Analysis Plan, all patients were analyzed within pre-specified populations across the entire trial. There was no plan to analyze cohorts separately; therefore, results are presented in aggregate. The trial was a single-arm design, not a classic dose-escalation study, as the RP2D (12 µg/kg) had been established in a prior trial (NCT04234113). The 9 µg/kg dose was a safety cohort allowing one-way crossover to 12 µg/kg.
Time to progression according to RECIST 1.1 was defined as the time from the first day of study treatment to the first date of radiological disease progression according to RECIST 1.1.
Outcome measures
| Measure |
Nanrilkefusp Alfa and Cetuximab
n=16 Participants
Participants were treated with nanrilkefusp alfa in combination with cetuximab. Safety cohort 1: 14 participants were treated with 9 µg/kg nanrilkefusp alfa; safety cohort 2: 2 participants were treated with 12 µg/kg nanrilkefusp alfa. Nanrilkefusp alfa treatment was administered on day 1 (from cycle 2 onwards, ±1 day), day 2 (±1 day), day 8 (±1 day), and day 9 (±1 day) of each 21-day cycle. Cetuximab treatment was administered on day 1 (from cycle 2 onwards, ±1 day), day 8 (±1 day), and day 15 (±1 day) of each 21-day cycle; on day 1 and day 8, cetuximab infusion started within 30 minutes after nanrilkefusp alfa administration.
|
|---|---|
|
Time to Progression According to RECIST 1.1
|
2.8 months
Interval 1.35 to 3.94
|
SECONDARY outcome
Timeframe: Day 1 up to approximately 1 year 5 monthsPopulation: Per statistical considerations outlined in the trial Protocol and Statistical Analysis Plan, all patients were analyzed within pre-specified populations across the entire trial. There was no plan to analyze cohorts separately; therefore, results are presented in aggregate. The trial was a single-arm design, not a classic dose-escalation study, as the RP2D (12 µg/kg) had been established in a prior trial (NCT04234113). The 9 µg/kg dose was a safety cohort allowing one-way crossover to 12 µg/kg.
Time to progression according to iRECIST was defined as the time from the first day of study treatment to the first date of radiological disease progression according to iRECIST.
Outcome measures
| Measure |
Nanrilkefusp Alfa and Cetuximab
n=16 Participants
Participants were treated with nanrilkefusp alfa in combination with cetuximab. Safety cohort 1: 14 participants were treated with 9 µg/kg nanrilkefusp alfa; safety cohort 2: 2 participants were treated with 12 µg/kg nanrilkefusp alfa. Nanrilkefusp alfa treatment was administered on day 1 (from cycle 2 onwards, ±1 day), day 2 (±1 day), day 8 (±1 day), and day 9 (±1 day) of each 21-day cycle. Cetuximab treatment was administered on day 1 (from cycle 2 onwards, ±1 day), day 8 (±1 day), and day 15 (±1 day) of each 21-day cycle; on day 1 and day 8, cetuximab infusion started within 30 minutes after nanrilkefusp alfa administration.
|
|---|---|
|
Time to Progression According to iRECIST
|
2.8 months
Interval 1.35 to 3.94
|
SECONDARY outcome
Timeframe: Day 1 up to approximately 1 year 5 monthsPopulation: Per statistical considerations outlined in the trial Protocol and Statistical Analysis Plan, all patients were analyzed within pre-specified populations across the entire trial. There was no plan to analyze cohorts separately; therefore, results are presented in aggregate. The trial was a single-arm design, not a classic dose-escalation study, as the RP2D (12 µg/kg) had been established in a prior trial (NCT04234113). The 9 µg/kg dose was a safety cohort allowing one-way crossover to 12 µg/kg.
A treatment-emergent adverse event is defined as an adverse event that started or worsened at or after the start of study treatment.
Outcome measures
| Measure |
Nanrilkefusp Alfa and Cetuximab
n=16 Participants
Participants were treated with nanrilkefusp alfa in combination with cetuximab. Safety cohort 1: 14 participants were treated with 9 µg/kg nanrilkefusp alfa; safety cohort 2: 2 participants were treated with 12 µg/kg nanrilkefusp alfa. Nanrilkefusp alfa treatment was administered on day 1 (from cycle 2 onwards, ±1 day), day 2 (±1 day), day 8 (±1 day), and day 9 (±1 day) of each 21-day cycle. Cetuximab treatment was administered on day 1 (from cycle 2 onwards, ±1 day), day 8 (±1 day), and day 15 (±1 day) of each 21-day cycle; on day 1 and day 8, cetuximab infusion started within 30 minutes after nanrilkefusp alfa administration.
|
|---|---|
|
Number of Participants With Treatment-emergent Adverse Events
|
16 Participants
|
SECONDARY outcome
Timeframe: Day 1 up to approximately 1 year 5 monthsPopulation: Per statistical considerations outlined in the trial Protocol and Statistical Analysis Plan, all patients were analyzed within pre-specified populations across the entire trial. There was no plan to analyze cohorts separately; therefore, results are presented in aggregate. The trial was a single-arm design, not a classic dose-escalation study, as the RP2D (12 µg/kg) had been established in a prior trial (NCT04234113). The 9 µg/kg dose was a safety cohort allowing one-way crossover to 12 µg/kg.
The following laboratory parameters will be assessed: Coagulation: prothrombin time, activated partial thromboplastin time, international normalized ratio, D-dimer, and fibrinogen Hematology: hemoglobin, glycated hemoglobin at screening, hematocrit, red blood cell count, reticulocytes, white blood cell count (with full differentiation), absolute lymphocyte count, and platelet count Clinical chemistry: Na, K, Cl, phosphate, Mg, Ca, albumin, total protein, ALT, AST, bilirubin (direct, total), alkaline phosphatase, lactate dehydrogenase, creatinine clearance calculated by the Cockcroft-Gault formula, creatinine, glucose (preferably fasting), urea or blood urea nitrogen, cholesterol, triglyceride, C-reactive protein, uric acid, amylase, and lipase Urinalysis: pH, glucose, protein, bilirubin, urobilinogen. Microscopic examination (mandated only if clinically indicated): red blood cell count, white blood cell count, epithelial cells, bacteria
Outcome measures
| Measure |
Nanrilkefusp Alfa and Cetuximab
n=16 Participants
Participants were treated with nanrilkefusp alfa in combination with cetuximab. Safety cohort 1: 14 participants were treated with 9 µg/kg nanrilkefusp alfa; safety cohort 2: 2 participants were treated with 12 µg/kg nanrilkefusp alfa. Nanrilkefusp alfa treatment was administered on day 1 (from cycle 2 onwards, ±1 day), day 2 (±1 day), day 8 (±1 day), and day 9 (±1 day) of each 21-day cycle. Cetuximab treatment was administered on day 1 (from cycle 2 onwards, ±1 day), day 8 (±1 day), and day 15 (±1 day) of each 21-day cycle; on day 1 and day 8, cetuximab infusion started within 30 minutes after nanrilkefusp alfa administration.
|
|---|---|
|
Number of Participants With Clinical Laboratory Test Abnormalities (Coagulation, Hematology, Clinical Chemistry and Urinalysis)
|
11 Participants
|
SECONDARY outcome
Timeframe: Day 1 up to approximately 1 year 5 monthsPopulation: Per statistical considerations outlined in the trial Protocol and Statistical Analysis Plan, all patients were analyzed within pre-specified populations across the entire trial. There was no plan to analyze cohorts separately; therefore, results are presented in aggregate. The trial was a single-arm design, not a classic dose-escalation study, as the RP2D (12 µg/kg) had been established in a prior trial (NCT04234113). The 9 µg/kg dose was a safety cohort allowing one-way crossover to 12 µg/kg.
The following vital signs parameters will be assessed: Blood pressure (systolic and diastolic, after ≥5 minutes of rest), body temperature, and heart rate
Outcome measures
| Measure |
Nanrilkefusp Alfa and Cetuximab
n=16 Participants
Participants were treated with nanrilkefusp alfa in combination with cetuximab. Safety cohort 1: 14 participants were treated with 9 µg/kg nanrilkefusp alfa; safety cohort 2: 2 participants were treated with 12 µg/kg nanrilkefusp alfa. Nanrilkefusp alfa treatment was administered on day 1 (from cycle 2 onwards, ±1 day), day 2 (±1 day), day 8 (±1 day), and day 9 (±1 day) of each 21-day cycle. Cetuximab treatment was administered on day 1 (from cycle 2 onwards, ±1 day), day 8 (±1 day), and day 15 (±1 day) of each 21-day cycle; on day 1 and day 8, cetuximab infusion started within 30 minutes after nanrilkefusp alfa administration.
|
|---|---|
|
Number of Participants With Vital Signs Abnormalities
|
11 Participants
|
SECONDARY outcome
Timeframe: Day 1 up to approximately 1 year 5 monthsPopulation: Per statistical considerations outlined in the trial Protocol and Statistical Analysis Plan, all patients were analyzed within pre-specified populations across the entire trial. There was no plan to analyze cohorts separately; therefore, results are presented in aggregate. The trial was a single-arm design, not a classic dose-escalation study, as the RP2D (12 µg/kg) had been established in a prior trial (NCT04234113). The 9 µg/kg dose was a safety cohort allowing one-way crossover to 12 µg/kg.
Standard 12-lead electrocardiography was evaluated locally.
Outcome measures
| Measure |
Nanrilkefusp Alfa and Cetuximab
n=16 Participants
Participants were treated with nanrilkefusp alfa in combination with cetuximab. Safety cohort 1: 14 participants were treated with 9 µg/kg nanrilkefusp alfa; safety cohort 2: 2 participants were treated with 12 µg/kg nanrilkefusp alfa. Nanrilkefusp alfa treatment was administered on day 1 (from cycle 2 onwards, ±1 day), day 2 (±1 day), day 8 (±1 day), and day 9 (±1 day) of each 21-day cycle. Cetuximab treatment was administered on day 1 (from cycle 2 onwards, ±1 day), day 8 (±1 day), and day 15 (±1 day) of each 21-day cycle; on day 1 and day 8, cetuximab infusion started within 30 minutes after nanrilkefusp alfa administration.
|
|---|---|
|
Number of Participants With Electrocardiography Abnormalities
|
1 Participants
|
SECONDARY outcome
Timeframe: Through Cycle 1 (21 days)Population: Per statistical considerations outlined in the trial Protocol and Statistical Analysis Plan, all patients were analyzed within pre-specified populations across the entire trial. There was no plan to analyze cohorts separately; therefore, results are presented in aggregate. The trial was a single-arm design, not a classic dose-escalation study, as the RP2D (12 µg/kg) had been established in a prior trial (NCT04234113). The 9 µg/kg dose was a safety cohort allowing one-way crossover to 12 µg/kg.
The following adverse events as per NCI CTCAE version 5.0 were considered dose-limiting toxicities: * All grade 5 events not clearly related to disease progression or any other causes * Any grade 3 or higher non-hematologic toxicity regardless of duration; exceptions: * Grade 3 nausea, vomiting, or diarrhea that could be controlled within 72 hours * Grade 3 fatigue lasting less than 5 days * Grade 3 or higher correctable electrolyte abnormalities lasting less than 72 hours and not associated with clinical complications * Grade 3 or higher serum amylase or lipase not associated with clinical manifestations of pancreatitis * Grade 3 AST or ALT increase or grade 3 blood bilirubin increase lasting 5 days or less * Hy's law cases * Hematologic DLTs: * Grade 4 decreased neutrophil count or decreased platelet count lasting more than 7 days * Febrile neutropenia * Grade 3 or higher decreased platelet count with bleeding
Outcome measures
| Measure |
Nanrilkefusp Alfa and Cetuximab
n=6 Participants
Participants were treated with nanrilkefusp alfa in combination with cetuximab. Safety cohort 1: 14 participants were treated with 9 µg/kg nanrilkefusp alfa; safety cohort 2: 2 participants were treated with 12 µg/kg nanrilkefusp alfa. Nanrilkefusp alfa treatment was administered on day 1 (from cycle 2 onwards, ±1 day), day 2 (±1 day), day 8 (±1 day), and day 9 (±1 day) of each 21-day cycle. Cetuximab treatment was administered on day 1 (from cycle 2 onwards, ±1 day), day 8 (±1 day), and day 15 (±1 day) of each 21-day cycle; on day 1 and day 8, cetuximab infusion started within 30 minutes after nanrilkefusp alfa administration.
|
|---|---|
|
Number of Participants With Dose-limiting Toxicities (DLTs)
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 of Cycle 1Population: Per statistical considerations outlined in the trial Protocol and Statistical Analysis Plan, all patients were analyzed within pre-specified populations across the entire trial. There was no plan to analyze cohorts separately; therefore, results are presented in aggregate. The trial was a single-arm design, not a classic dose-escalation study, as the RP2D (12 µg/kg) had been established in a prior trial (NCT04234113). The 9 µg/kg dose was a safety cohort allowing one-way crossover to 12 µg/kg.
At 9 µg/kg nanrilkefusp alfa on Day 1 of Cycle 1
Outcome measures
| Measure |
Nanrilkefusp Alfa and Cetuximab
n=13 Participants
Participants were treated with nanrilkefusp alfa in combination with cetuximab. Safety cohort 1: 14 participants were treated with 9 µg/kg nanrilkefusp alfa; safety cohort 2: 2 participants were treated with 12 µg/kg nanrilkefusp alfa. Nanrilkefusp alfa treatment was administered on day 1 (from cycle 2 onwards, ±1 day), day 2 (±1 day), day 8 (±1 day), and day 9 (±1 day) of each 21-day cycle. Cetuximab treatment was administered on day 1 (from cycle 2 onwards, ±1 day), day 8 (±1 day), and day 15 (±1 day) of each 21-day cycle; on day 1 and day 8, cetuximab infusion started within 30 minutes after nanrilkefusp alfa administration.
|
|---|---|
|
Characterization of Area Under the Curve of Nanrilkefusp Alfa
|
37.1 h*ng/mL
Interval 21.8 to 88.5
|
SECONDARY outcome
Timeframe: Day 1 of Cycle 1Population: Per statistical considerations outlined in the trial Protocol and Statistical Analysis Plan, all patients were analyzed within pre-specified populations across the entire trial. There was no plan to analyze cohorts separately; therefore, results are presented in aggregate. The trial was a single-arm design, not a classic dose-escalation study, as the RP2D (12 µg/kg) had been established in a prior trial (NCT04234113). The 9 µg/kg dose was a safety cohort allowing one-way crossover to 12 µg/kg.
At 9 µg/kg nanrilkefusp alfa
Outcome measures
| Measure |
Nanrilkefusp Alfa and Cetuximab
n=13 Participants
Participants were treated with nanrilkefusp alfa in combination with cetuximab. Safety cohort 1: 14 participants were treated with 9 µg/kg nanrilkefusp alfa; safety cohort 2: 2 participants were treated with 12 µg/kg nanrilkefusp alfa. Nanrilkefusp alfa treatment was administered on day 1 (from cycle 2 onwards, ±1 day), day 2 (±1 day), day 8 (±1 day), and day 9 (±1 day) of each 21-day cycle. Cetuximab treatment was administered on day 1 (from cycle 2 onwards, ±1 day), day 8 (±1 day), and day 15 (±1 day) of each 21-day cycle; on day 1 and day 8, cetuximab infusion started within 30 minutes after nanrilkefusp alfa administration.
|
|---|---|
|
Characterization of Maximum Concentration of Nanrilkefusp Alfa on Day 1 of Cycle 1
|
3.56 ng/mL
Interval 1.45 to 6.78
|
SECONDARY outcome
Timeframe: Day 1 of Cycle 1Population: Per statistical considerations outlined in the trial Protocol and Statistical Analysis Plan, all patients were analyzed within pre-specified populations across the entire trial. There was no plan to analyze cohorts separately; therefore, results are presented in aggregate. The trial was a single-arm design, not a classic dose-escalation study, as the RP2D (12 µg/kg) had been established in a prior trial (NCT04234113). The 9 µg/kg dose was a safety cohort allowing one-way crossover to 12 µg/kg.
At 9 µg/kg nanrilkefusp alfa
Outcome measures
| Measure |
Nanrilkefusp Alfa and Cetuximab
n=13 Participants
Participants were treated with nanrilkefusp alfa in combination with cetuximab. Safety cohort 1: 14 participants were treated with 9 µg/kg nanrilkefusp alfa; safety cohort 2: 2 participants were treated with 12 µg/kg nanrilkefusp alfa. Nanrilkefusp alfa treatment was administered on day 1 (from cycle 2 onwards, ±1 day), day 2 (±1 day), day 8 (±1 day), and day 9 (±1 day) of each 21-day cycle. Cetuximab treatment was administered on day 1 (from cycle 2 onwards, ±1 day), day 8 (±1 day), and day 15 (±1 day) of each 21-day cycle; on day 1 and day 8, cetuximab infusion started within 30 minutes after nanrilkefusp alfa administration.
|
|---|---|
|
Characterization of Time to Maximum Concentration of Nanrilkefusp Alfa on Day 1 of Cycle 1
|
6.21 hours
Interval 2.03 to 22.8
|
SECONDARY outcome
Timeframe: Day 1 of Cycle 1Population: Per statistical considerations outlined in the trial Protocol and Statistical Analysis Plan, all patients were analyzed within pre-specified populations across the entire trial. There was no plan to analyze cohorts separately; therefore, results are presented in aggregate. The trial was a single-arm design, not a classic dose-escalation study, as the RP2D (12 µg/kg) had been established in a prior trial (NCT04234113). The 9 µg/kg dose was a safety cohort allowing one-way crossover to 12 µg/kg.
At 9 µg/kg nanrilkefusp alfa
Outcome measures
| Measure |
Nanrilkefusp Alfa and Cetuximab
n=13 Participants
Participants were treated with nanrilkefusp alfa in combination with cetuximab. Safety cohort 1: 14 participants were treated with 9 µg/kg nanrilkefusp alfa; safety cohort 2: 2 participants were treated with 12 µg/kg nanrilkefusp alfa. Nanrilkefusp alfa treatment was administered on day 1 (from cycle 2 onwards, ±1 day), day 2 (±1 day), day 8 (±1 day), and day 9 (±1 day) of each 21-day cycle. Cetuximab treatment was administered on day 1 (from cycle 2 onwards, ±1 day), day 8 (±1 day), and day 15 (±1 day) of each 21-day cycle; on day 1 and day 8, cetuximab infusion started within 30 minutes after nanrilkefusp alfa administration.
|
|---|---|
|
Characterization of Pre-dose Concentration of Nanrilkefusp Alfa on Day 1 of Cycle 1
|
0.404 ng/mL
Interval 0.178 to 1.5
|
SECONDARY outcome
Timeframe: Day 1 until 30 (±2) days after the last dose of nanrilkefusp alfa, up to approximately 1 year 5 monthsPopulation: Per statistical considerations outlined in the trial Protocol and Statistical Analysis Plan, all patients were analyzed within pre-specified populations across the entire trial. There was no plan to analyze cohorts separately; therefore, results are presented in aggregate. The trial was a single-arm design, not a classic dose-escalation study, as the RP2D (12 µg/kg) had been established in a prior trial (NCT04234113). The 9 µg/kg dose was a safety cohort allowing one-way crossover to 12 µg/kg.
At 9 µg/kg and 12 µg/kg nanrilkefusp alfa
Outcome measures
| Measure |
Nanrilkefusp Alfa and Cetuximab
n=16 Participants
Participants were treated with nanrilkefusp alfa in combination with cetuximab. Safety cohort 1: 14 participants were treated with 9 µg/kg nanrilkefusp alfa; safety cohort 2: 2 participants were treated with 12 µg/kg nanrilkefusp alfa. Nanrilkefusp alfa treatment was administered on day 1 (from cycle 2 onwards, ±1 day), day 2 (±1 day), day 8 (±1 day), and day 9 (±1 day) of each 21-day cycle. Cetuximab treatment was administered on day 1 (from cycle 2 onwards, ±1 day), day 8 (±1 day), and day 15 (±1 day) of each 21-day cycle; on day 1 and day 8, cetuximab infusion started within 30 minutes after nanrilkefusp alfa administration.
|
|---|---|
|
Incidence of Treatment-induced Anti-drug Antibodies Against Nanrilkefusp Alfa
|
5 Participants
|
Adverse Events
Nanrilkefusp Alfa and Cetuximab 9 µg/kg (Safety Cohort 1)
Serious events: 7 serious events
Other events: 14 other events
Deaths: 7 deaths
Nanrilkefusp Alfa and Cetuximab 12 µg/kg (Safety Cohort 2)
Serious events: 1 serious events
Other events: 2 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Nanrilkefusp Alfa and Cetuximab 9 µg/kg (Safety Cohort 1)
n=14 participants at risk
Participants were treated with nanrilkefusp alfa in combination with cetuximab. 14 participants were treated with 9 µg/kg nanrilkefusp alfa. Nanrilkefusp alfa treatment was administered on day 1 (from cycle 2 onwards, ±1 day), day 2 (±1 day), day 8 (±1 day), and day 9 (±1 day) of each 21-day cycle. Cetuximab treatment was administered on day 1 (from cycle 2 onwards, ±1 day), day 8 (±1 day), and day 15 (±1 day) of each 21-day cycle; on day 1 and day 8, cetuximab infusion started within 30 minutes after nanrilkefusp alfa administration.
|
Nanrilkefusp Alfa and Cetuximab 12 µg/kg (Safety Cohort 2)
n=2 participants at risk
Participants were treated with nanrilkefusp alfa in combination with cetuximab. 2 participants were treated with 12 µg/kg nanrilkefusp alfa. Nanrilkefusp alfa treatment was administered on day 1 (from cycle 2 onwards, ±1 day), day 2 (±1 day), day 8 (±1 day), and day 9 (±1 day) of each 21-day cycle. Cetuximab treatment was administered on day 1 (from cycle 2 onwards, ±1 day), day 8 (±1 day), and day 15 (±1 day) of each 21-day cycle; on day 1 and day 8, cetuximab infusion started within 30 minutes after nanrilkefusp alfa administration.
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
14.3%
2/14 • Number of events 2 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
50.0%
1/2 • Number of events 1 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
|
Investigations
Alanine aminotransferase increased
|
7.1%
1/14 • Number of events 1 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
0.00%
0/2 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
|
Investigations
Aspartate aminotransferase increased
|
7.1%
1/14 • Number of events 1 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
0.00%
0/2 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
|
Investigations
Blood bilirubin increased
|
7.1%
1/14 • Number of events 1 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
0.00%
0/2 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
|
General disorders
Disease progression
|
14.3%
2/14 • Number of events 2 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
0.00%
0/2 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
|
General disorders
General physical health deterioration
|
7.1%
1/14 • Number of events 1 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
0.00%
0/2 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
|
General disorders
Pyrexia
|
7.1%
1/14 • Number of events 1 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
0.00%
0/2 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
|
Gastrointestinal disorders
Abdominal pain
|
7.1%
1/14 • Number of events 1 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
0.00%
0/2 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
7.1%
1/14 • Number of events 1 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
0.00%
0/2 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
7.1%
1/14 • Number of events 1 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
0.00%
0/2 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
|
Infections and infestations
Device related infection
|
7.1%
1/14 • Number of events 1 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
0.00%
0/2 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
|
Infections and infestations
Sepsis
|
7.1%
1/14 • Number of events 1 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
0.00%
0/2 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
Other adverse events
| Measure |
Nanrilkefusp Alfa and Cetuximab 9 µg/kg (Safety Cohort 1)
n=14 participants at risk
Participants were treated with nanrilkefusp alfa in combination with cetuximab. 14 participants were treated with 9 µg/kg nanrilkefusp alfa. Nanrilkefusp alfa treatment was administered on day 1 (from cycle 2 onwards, ±1 day), day 2 (±1 day), day 8 (±1 day), and day 9 (±1 day) of each 21-day cycle. Cetuximab treatment was administered on day 1 (from cycle 2 onwards, ±1 day), day 8 (±1 day), and day 15 (±1 day) of each 21-day cycle; on day 1 and day 8, cetuximab infusion started within 30 minutes after nanrilkefusp alfa administration.
|
Nanrilkefusp Alfa and Cetuximab 12 µg/kg (Safety Cohort 2)
n=2 participants at risk
Participants were treated with nanrilkefusp alfa in combination with cetuximab. 2 participants were treated with 12 µg/kg nanrilkefusp alfa. Nanrilkefusp alfa treatment was administered on day 1 (from cycle 2 onwards, ±1 day), day 2 (±1 day), day 8 (±1 day), and day 9 (±1 day) of each 21-day cycle. Cetuximab treatment was administered on day 1 (from cycle 2 onwards, ±1 day), day 8 (±1 day), and day 15 (±1 day) of each 21-day cycle; on day 1 and day 8, cetuximab infusion started within 30 minutes after nanrilkefusp alfa administration.
|
|---|---|---|
|
Vascular disorders
Hypotension
|
14.3%
2/14 • Number of events 4 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
0.00%
0/2 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
|
Vascular disorders
Raynaud's phenomenon
|
7.1%
1/14 • Number of events 1 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
0.00%
0/2 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
|
General disorders
Fatigue
|
71.4%
10/14 • Number of events 12 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
50.0%
1/2 • Number of events 1 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
|
General disorders
Pyrexia
|
57.1%
8/14 • Number of events 26 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
100.0%
2/2 • Number of events 2 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
|
General disorders
Injection site reaction
|
50.0%
7/14 • Number of events 7 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
0.00%
0/2 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
|
General disorders
Chills
|
14.3%
2/14 • Number of events 6 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
50.0%
1/2 • Number of events 1 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
|
Immune system disorders
Cytokine release syndrome
|
7.1%
1/14 • Number of events 1 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
0.00%
0/2 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
|
Immune system disorders
Hypersensitivity
|
7.1%
1/14 • Number of events 1 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
0.00%
0/2 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
21.4%
3/14 • Number of events 3 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
0.00%
0/2 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
14.3%
2/14 • Number of events 2 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
0.00%
0/2 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
7.1%
1/14 • Number of events 1 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
0.00%
0/2 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
7.1%
1/14 • Number of events 1 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
0.00%
0/2 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
|
Psychiatric disorders
Depression
|
7.1%
1/14 • Number of events 1 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
0.00%
0/2 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
|
Psychiatric disorders
Insomnia
|
7.1%
1/14 • Number of events 1 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
0.00%
0/2 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
|
Psychiatric disorders
Irritability
|
7.1%
1/14 • Number of events 1 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
0.00%
0/2 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
|
Investigations
Aspartate aminotransferase increased
|
28.6%
4/14 • Number of events 4 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
0.00%
0/2 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
|
Investigations
Alanine aminotransferase increased
|
21.4%
3/14 • Number of events 4 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
0.00%
0/2 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
|
Investigations
Blood bilirubin increased
|
14.3%
2/14 • Number of events 2 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
0.00%
0/2 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
|
Investigations
Amylase increased
|
7.1%
1/14 • Number of events 1 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
0.00%
0/2 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
|
Investigations
C-reactive protein increased
|
7.1%
1/14 • Number of events 1 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
0.00%
0/2 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
|
Investigations
Gamma-glutamyltransferase increased
|
7.1%
1/14 • Number of events 1 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
0.00%
0/2 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
|
Investigations
Lymphocyte count decreased
|
7.1%
1/14 • Number of events 1 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
0.00%
0/2 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
|
Investigations
Platelet count decreased
|
7.1%
1/14 • Number of events 1 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
0.00%
0/2 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
7.1%
1/14 • Number of events 1 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
50.0%
1/2 • Number of events 2 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
|
Cardiac disorders
Sinus tachycardia
|
7.1%
1/14 • Number of events 1 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
0.00%
0/2 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
|
Nervous system disorders
Dizziness
|
14.3%
2/14 • Number of events 2 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
0.00%
0/2 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
|
Nervous system disorders
Dysgeusia
|
7.1%
1/14 • Number of events 1 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
0.00%
0/2 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
|
Nervous system disorders
Headache
|
7.1%
1/14 • Number of events 1 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
0.00%
0/2 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
|
Nervous system disorders
Paraesthesia
|
7.1%
1/14 • Number of events 1 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
0.00%
0/2 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
7.1%
1/14 • Number of events 1 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
0.00%
0/2 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
|
Blood and lymphatic system disorders
Anaemia
|
35.7%
5/14 • Number of events 8 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
50.0%
1/2 • Number of events 1 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
|
Eye disorders
Lacrimation increased
|
7.1%
1/14 • Number of events 1 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
0.00%
0/2 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
|
Gastrointestinal disorders
Vomiting
|
35.7%
5/14 • Number of events 6 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
50.0%
1/2 • Number of events 1 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
|
Gastrointestinal disorders
Nausea
|
28.6%
4/14 • Number of events 4 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
100.0%
2/2 • Number of events 2 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
|
Gastrointestinal disorders
Diarrhoea
|
28.6%
4/14 • Number of events 5 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
0.00%
0/2 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
|
Gastrointestinal disorders
Abdominal pain
|
14.3%
2/14 • Number of events 2 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
100.0%
2/2 • Number of events 2 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
|
Gastrointestinal disorders
Stomatitis
|
28.6%
4/14 • Number of events 4 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
0.00%
0/2 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
|
Gastrointestinal disorders
Constipation
|
7.1%
1/14 • Number of events 1 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
0.00%
0/2 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
|
Gastrointestinal disorders
Dry mouth
|
7.1%
1/14 • Number of events 1 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
0.00%
0/2 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
|
Gastrointestinal disorders
Flatulence
|
7.1%
1/14 • Number of events 1 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
0.00%
0/2 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
7.1%
1/14 • Number of events 1 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
0.00%
0/2 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/14 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
50.0%
1/2 • Number of events 1 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
|
Gastrointestinal disorders
Oral dysaesthesia
|
7.1%
1/14 • Number of events 1 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
0.00%
0/2 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
57.1%
8/14 • Number of events 11 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
0.00%
0/2 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
|
Skin and subcutaneous tissue disorders
Rash
|
28.6%
4/14 • Number of events 4 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
0.00%
0/2 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
14.3%
2/14 • Number of events 3 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
0.00%
0/2 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
7.1%
1/14 • Number of events 1 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
0.00%
0/2 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.1%
1/14 • Number of events 1 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
0.00%
0/2 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
7.1%
1/14 • Number of events 1 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
0.00%
0/2 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
|
Skin and subcutaneous tissue disorders
Skin toxicity
|
0.00%
0/14 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
50.0%
1/2 • Number of events 1 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
14.3%
2/14 • Number of events 2 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
0.00%
0/2 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/14 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
50.0%
1/2 • Number of events 4 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
|
Infections and infestations
Urinary tract infection
|
14.3%
2/14 • Number of events 2 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
0.00%
0/2 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
|
Infections and infestations
Rhinitis
|
7.1%
1/14 • Number of events 2 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
0.00%
0/2 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
|
Infections and infestations
COVID-19
|
7.1%
1/14 • Number of events 1 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
0.00%
0/2 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
|
Infections and infestations
Candida infection
|
7.1%
1/14 • Number of events 1 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
0.00%
0/2 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
|
Infections and infestations
Conjunctivitis
|
7.1%
1/14 • Number of events 1 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
0.00%
0/2 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
|
Infections and infestations
Otitis externa
|
7.1%
1/14 • Number of events 1 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
0.00%
0/2 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
|
Infections and infestations
Paronychia
|
7.1%
1/14 • Number of events 1 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
0.00%
0/2 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
|
Infections and infestations
Wound infection
|
7.1%
1/14 • Number of events 1 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
0.00%
0/2 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
28.6%
4/14 • Number of events 7 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
0.00%
0/2 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
28.6%
4/14 • Number of events 4 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
0.00%
0/2 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
21.4%
3/14 • Number of events 3 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
0.00%
0/2 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
14.3%
2/14 • Number of events 2 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
0.00%
0/2 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
7.1%
1/14 • Number of events 1 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
0.00%
0/2 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
7.1%
1/14 • Number of events 1 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
0.00%
0/2 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
7.1%
1/14 • Number of events 1 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
0.00%
0/2 • Adverse events: from the start of study treatment to 90 days after the end of study treatment up to approximately 1 year 5 months; related serious adverse events: collected beyond 90 days after the end of study treatment up to approximately 1 year 5 months; deaths: consent signature to study end up to approximately 1 year 5 months
Only treatment-emergent adverse events were analyzed (see the definition above); the tables include information on treatment-emergent adverse events, serious treatment-emergent adverse events, and all deaths; causality was assessed by investigators. The two safety cohorts are not described separately due to the small number of participants in safety cohort 2.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The results will be published and/or presented at scientific meetings in their totality in a timely manner. Any formal publication of clinical trial results will be a collaborative effort between the sponsor and the investigator(s). All manuscripts or abstracts will be reviewed and approved in written by the sponsor before submission. The sponsor may request a delay in publication if there are important intellectual property concerns.
- Publication restrictions are in place
Restriction type: OTHER