Trial Outcomes & Findings for VIC-1911 Monotherapy in Combination With Sotorasib for the Treatment of KRAS G12C-Mutant Non-Small Cell Lung Cancer (NCT NCT05374538)
NCT ID: NCT05374538
Last Updated: 2025-05-01
Results Overview
Safety and tolerability assessed by adverse events(AEs) and serious adverse events (SAEs)
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
3 participants
Primary outcome timeframe
9 months
Results posted on
2025-05-01
Participant Flow
Participant milestones
| Measure |
Dose Escalation Phase, Cohort 1a: VIC-1911 Monotherapy
Subjects with locally advanced or metastatic KRAS G12C-mutated NSCLC refractory to or relapsed on prior KRASG12C inhibitor therapy will receive VIC-1911 monotherapy.
VIC-1911: VIC-1911 tablets for oral administration
|
Dose Escalation Phase, Cohort 1b: VIC-1911 Plus Sotorasib Combination Therapy
Subjects with locally advanced or metastatic KRAS G12C-mutated NSCLC refractory to or relapsed on prior KRASG12C inhibitor therapy or are naive to KRAS G12C inhibitor therapy will receive VIC-1911 plus sotorasib combination therapy.
VIC-1911: VIC-1911 tablets for oral administration
sotorasib: Sotorasib tablets for oral administration
Only Dose Level 1 was opened and all 3 subjects received sotorasib 960 mg QD PO, VIC-1911 75 mg BID PO.
|
Expansion Phase, Cohort 2a: VIC-1911 Monotherapy
Subjects with locally advanced or metastatic KRAS G12C-mutated NSCLC refractory to or relapsed on prior KRASG12C inhibitor therapy will receive VIC-1911 monotherapy.
VIC-1911: VIC-1911 tablets for oral administration
|
Expansion Phase, Cohort 2b: VIC-1911 Plus Sotorasib Combination Therapy
Subjects with locally advanced or metastatic KRAS G12C-mutated NSCLC refractory to or relapsed on prior KRASG12C inhibitor therapy will receive VIC-1911 plus sotorasib combination therapy.
VIC-1911: VIC-1911 tablets for oral administration
sotorasib: Sotorasib tablets for oral administration
|
Expansion Phase, Cohort 2c: VIC-1911 Plus Sotorasib Combination Therapy
Subjects with locally advanced or metastatic KRAS G12C-mutated NSCLC naive to KRAS G12C inhibitor therapy will receive VIC-1911 plus sotorasib combination therapy.
VIC-1911: VIC-1911 tablets for oral administration
sotorasib: Sotorasib tablets for oral administration
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
0
|
3
|
0
|
0
|
0
|
|
Overall Study
COMPLETED
|
0
|
3
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
VIC-1911 Monotherapy in Combination With Sotorasib for the Treatment of KRAS G12C-Mutant Non-Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Dose Escalation Phase, Cohort 1a: VIC-1911 Monotherapy
Subjects with locally advanced or metastatic KRAS G12C-mutated NSCLC refractory to or relapsed on prior KRASG12C inhibitor therapy will receive VIC-1911 monotherapy.
VIC-1911: VIC-1911 tablets for oral administration
|
Dose Escalation Phase, Cohort 1b: VIC-1911 Plus Sotorasib Combination Therapy
n=3 Participants
Subjects with locally advanced or metastatic KRAS G12C-mutated NSCLC refractory to or relapsed on prior KRASG12C inhibitor therapy or are naive to KRAS G12C inhibitor therapy will receive VIC-1911 plus sotorasib combination therapy.
VIC-1911: VIC-1911 tablets for oral administration
sotorasib: Sotorasib tablets for oral administration
Only Dose Level 1 was opened and all 3 subjects received sotorasib 960 mg QD PO, VIC-1911 75 mg BID PO.
|
Expansion Phase, Cohort 2a: VIC-1911 Monotherapy
Subjects with locally advanced or metastatic KRAS G12C-mutated NSCLC refractory to or relapsed on prior KRASG12C inhibitor therapy will receive VIC-1911 monotherapy.
VIC-1911: VIC-1911 tablets for oral administration
|
Expansion Phase, Cohort 2b: VIC-1911 Plus Sotorasib Combination Therapy
Subjects with locally advanced or metastatic KRAS G12C-mutated NSCLC refractory to or relapsed on prior KRASG12C inhibitor therapy will receive VIC-1911 plus sotorasib combination therapy.
VIC-1911: VIC-1911 tablets for oral administration
sotorasib: Sotorasib tablets for oral administration
|
Expansion Phase, Cohort 2c: VIC-1911 Plus Sotorasib Combination Therapy
Subjects with locally advanced or metastatic KRAS G12C-mutated NSCLC naive to KRAS G12C inhibitor therapy will receive VIC-1911 plus sotorasib combination therapy.
VIC-1911: VIC-1911 tablets for oral administration
sotorasib: Sotorasib tablets for oral administration
|
Total
n=3 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
—
|
1 Participants
n=107 Participants
|
—
|
—
|
—
|
1 Participants
n=30 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
—
|
0 Participants
n=107 Participants
|
—
|
—
|
—
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Asian
|
—
|
0 Participants
n=107 Participants
|
—
|
—
|
—
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
—
|
0 Participants
n=107 Participants
|
—
|
—
|
—
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Black or African American
|
—
|
0 Participants
n=107 Participants
|
—
|
—
|
—
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
White
|
—
|
1 Participants
n=107 Participants
|
—
|
—
|
—
|
1 Participants
n=30 Participants
|
|
Race (NIH/OMB)
More than one race
|
—
|
0 Participants
n=107 Participants
|
—
|
—
|
—
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
—
|
2 Participants
n=107 Participants
|
—
|
—
|
—
|
2 Participants
n=30 Participants
|
|
Region of Enrollment
United States
|
—
|
3 Participants
n=107 Participants
|
—
|
—
|
—
|
3 Participants
n=30 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
|
Age, Continuous
|
—
|
60.3 years
n=107 Participants
|
—
|
—
|
—
|
60.3 years
n=30 Participants
|
|
Sex: Female, Male
Female
|
—
|
2 Participants
n=107 Participants
|
—
|
—
|
—
|
2 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
—
|
1 Participants
n=107 Participants
|
—
|
—
|
—
|
1 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
—
|
0 Participants
n=107 Participants
|
—
|
—
|
—
|
0 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
—
|
2 Participants
n=107 Participants
|
—
|
—
|
—
|
2 Participants
n=30 Participants
|
PRIMARY outcome
Timeframe: 9 monthsPopulation: No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
Safety and tolerability assessed by adverse events(AEs) and serious adverse events (SAEs)
Outcome measures
| Measure |
Dose Escalation Phase, Cohort 1b: VIC-1911 Plus Sotorasib Combination Therapy
n=3 Participants
Subjects with locally advanced or metastatic KRAS G12C-mutated NSCLC refractory to or relapsed on prior KRASG12C inhibitor therapy or are naive to KRAS G12C inhibitor therapy will receive VIC-1911 plus sotorasib combination therapy.
VIC-1911: VIC-1911 tablets for oral administration
sotorasib: Sotorasib tablets for oral administration
Only Dose Level 1 was opened and all 3 subjects received sotorasib 960 mg QD PO, VIC-1911 75 mg BID PO.
|
Expansion Phase, Cohort 2a: VIC-1911 Monotherapy
Subjects with locally advanced or metastatic KRAS G12C-mutated NSCLC refractory to or relapsed on prior KRASG12C inhibitor therapy will receive VIC-1911 monotherapy.
VIC-1911: VIC-1911 tablets for oral administration
|
Expansion Phase, Cohort 2b: VIC-1911 Plus Sotorasib Combination Therapy
Subjects with locally advanced or metastatic KRAS G12C-mutated NSCLC refractory to or relapsed on prior KRASG12C inhibitor therapy will receive VIC-1911 plus sotorasib combination therapy.
VIC-1911: VIC-1911 tablets for oral administration
sotorasib: Sotorasib tablets for oral administration
|
Dose Escalation Phase, Cohort 1a: VIC-1911 Monotherapy
Subjects with locally advanced or metastatic KRAS G12C-mutated NSCLC refractory to or relapsed on prior KRASG12C inhibitor therapy will receive VIC-1911 monotherapy.
VIC-1911: VIC-1911 tablets for oral administration
|
Expansion Phase, Cohort 2c: VIC-1911 Plus Sotorasib Combination Therapy
Subjects with locally advanced or metastatic KRAS G12C-mutated NSCLC naive to KRAS G12C inhibitor therapy will receive VIC-1911 plus sotorasib combination therapy.
VIC-1911: VIC-1911 tablets for oral administration
sotorasib: Sotorasib tablets for oral administration
|
|---|---|---|---|---|---|
|
Incidence of Treatment Emergent Adverse Events (Safety and Tolerability)
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Assessed at the end of Cycle 2 and every 2 cycles thereafter up to 8 months. Each cycle is 28 days.Population: No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
Proportion of subjects with objective responses (complete response \[CR\] + partial response \[PR\]) as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1.
Outcome measures
| Measure |
Dose Escalation Phase, Cohort 1b: VIC-1911 Plus Sotorasib Combination Therapy
n=3 Participants
Subjects with locally advanced or metastatic KRAS G12C-mutated NSCLC refractory to or relapsed on prior KRASG12C inhibitor therapy or are naive to KRAS G12C inhibitor therapy will receive VIC-1911 plus sotorasib combination therapy.
VIC-1911: VIC-1911 tablets for oral administration
sotorasib: Sotorasib tablets for oral administration
Only Dose Level 1 was opened and all 3 subjects received sotorasib 960 mg QD PO, VIC-1911 75 mg BID PO.
|
Expansion Phase, Cohort 2a: VIC-1911 Monotherapy
Subjects with locally advanced or metastatic KRAS G12C-mutated NSCLC refractory to or relapsed on prior KRASG12C inhibitor therapy will receive VIC-1911 monotherapy.
VIC-1911: VIC-1911 tablets for oral administration
|
Expansion Phase, Cohort 2b: VIC-1911 Plus Sotorasib Combination Therapy
Subjects with locally advanced or metastatic KRAS G12C-mutated NSCLC refractory to or relapsed on prior KRASG12C inhibitor therapy will receive VIC-1911 plus sotorasib combination therapy.
VIC-1911: VIC-1911 tablets for oral administration
sotorasib: Sotorasib tablets for oral administration
|
Dose Escalation Phase, Cohort 1a: VIC-1911 Monotherapy
Subjects with locally advanced or metastatic KRAS G12C-mutated NSCLC refractory to or relapsed on prior KRASG12C inhibitor therapy will receive VIC-1911 monotherapy.
VIC-1911: VIC-1911 tablets for oral administration
|
Expansion Phase, Cohort 2c: VIC-1911 Plus Sotorasib Combination Therapy
Subjects with locally advanced or metastatic KRAS G12C-mutated NSCLC naive to KRAS G12C inhibitor therapy will receive VIC-1911 plus sotorasib combination therapy.
VIC-1911: VIC-1911 tablets for oral administration
sotorasib: Sotorasib tablets for oral administration
|
|---|---|---|---|---|---|
|
Objective Response Rate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Assessed at the end of Cycle 2 and every 2 cycles thereafter up to 8 months. Each cycle is 28 days.Population: No data displayed because Outcome Measure had zero participants with CR or PR.
Length of time from first evidence of objective response (complete response \[CR\] or partial response \[PR\]) to the first objective evidence of disease progression
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Assessed at the end of Cycle 2 and every 2 cycles thereafter up to 8 months. Each cycle is 28 days.Population: No data displayed because Outcome Measure had zero participants with CR or PR.
Length of time from the date of first dose of study drug to the first evidence of objective response (CR,PR)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Assessed at the end of Cycle 2 and every 2 cycles thereafter up to 8 months. Each cycle is 28 days.Population: No data displayed because Outcome Measure had zero participants with CR, PR or SD.
Proportion of subjects with best response of CR, PR or stable disease (SD)
Outcome measures
| Measure |
Dose Escalation Phase, Cohort 1b: VIC-1911 Plus Sotorasib Combination Therapy
n=3 Participants
Subjects with locally advanced or metastatic KRAS G12C-mutated NSCLC refractory to or relapsed on prior KRASG12C inhibitor therapy or are naive to KRAS G12C inhibitor therapy will receive VIC-1911 plus sotorasib combination therapy.
VIC-1911: VIC-1911 tablets for oral administration
sotorasib: Sotorasib tablets for oral administration
Only Dose Level 1 was opened and all 3 subjects received sotorasib 960 mg QD PO, VIC-1911 75 mg BID PO.
|
Expansion Phase, Cohort 2a: VIC-1911 Monotherapy
Subjects with locally advanced or metastatic KRAS G12C-mutated NSCLC refractory to or relapsed on prior KRASG12C inhibitor therapy will receive VIC-1911 monotherapy.
VIC-1911: VIC-1911 tablets for oral administration
|
Expansion Phase, Cohort 2b: VIC-1911 Plus Sotorasib Combination Therapy
Subjects with locally advanced or metastatic KRAS G12C-mutated NSCLC refractory to or relapsed on prior KRASG12C inhibitor therapy will receive VIC-1911 plus sotorasib combination therapy.
VIC-1911: VIC-1911 tablets for oral administration
sotorasib: Sotorasib tablets for oral administration
|
Dose Escalation Phase, Cohort 1a: VIC-1911 Monotherapy
Subjects with locally advanced or metastatic KRAS G12C-mutated NSCLC refractory to or relapsed on prior KRASG12C inhibitor therapy will receive VIC-1911 monotherapy.
VIC-1911: VIC-1911 tablets for oral administration
|
Expansion Phase, Cohort 2c: VIC-1911 Plus Sotorasib Combination Therapy
Subjects with locally advanced or metastatic KRAS G12C-mutated NSCLC naive to KRAS G12C inhibitor therapy will receive VIC-1911 plus sotorasib combination therapy.
VIC-1911: VIC-1911 tablets for oral administration
sotorasib: Sotorasib tablets for oral administration
|
|---|---|---|---|---|---|
|
Disease Control Rate
|
0 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Assessed from the date of the first dose of study drug to the first evidence of disease progression or death, whichever is earlier, assessed up to 9 monthsPopulation: No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
Length of time from the date of first dose of study drug to the first evidence of disease progression or death, whichever is earlier
Outcome measures
| Measure |
Dose Escalation Phase, Cohort 1b: VIC-1911 Plus Sotorasib Combination Therapy
n=3 Participants
Subjects with locally advanced or metastatic KRAS G12C-mutated NSCLC refractory to or relapsed on prior KRASG12C inhibitor therapy or are naive to KRAS G12C inhibitor therapy will receive VIC-1911 plus sotorasib combination therapy.
VIC-1911: VIC-1911 tablets for oral administration
sotorasib: Sotorasib tablets for oral administration
Only Dose Level 1 was opened and all 3 subjects received sotorasib 960 mg QD PO, VIC-1911 75 mg BID PO.
|
Expansion Phase, Cohort 2a: VIC-1911 Monotherapy
Subjects with locally advanced or metastatic KRAS G12C-mutated NSCLC refractory to or relapsed on prior KRASG12C inhibitor therapy will receive VIC-1911 monotherapy.
VIC-1911: VIC-1911 tablets for oral administration
|
Expansion Phase, Cohort 2b: VIC-1911 Plus Sotorasib Combination Therapy
Subjects with locally advanced or metastatic KRAS G12C-mutated NSCLC refractory to or relapsed on prior KRASG12C inhibitor therapy will receive VIC-1911 plus sotorasib combination therapy.
VIC-1911: VIC-1911 tablets for oral administration
sotorasib: Sotorasib tablets for oral administration
|
Dose Escalation Phase, Cohort 1a: VIC-1911 Monotherapy
Subjects with locally advanced or metastatic KRAS G12C-mutated NSCLC refractory to or relapsed on prior KRASG12C inhibitor therapy will receive VIC-1911 monotherapy.
VIC-1911: VIC-1911 tablets for oral administration
|
Expansion Phase, Cohort 2c: VIC-1911 Plus Sotorasib Combination Therapy
Subjects with locally advanced or metastatic KRAS G12C-mutated NSCLC naive to KRAS G12C inhibitor therapy will receive VIC-1911 plus sotorasib combination therapy.
VIC-1911: VIC-1911 tablets for oral administration
sotorasib: Sotorasib tablets for oral administration
|
|---|---|---|---|---|---|
|
Progression-Free Survival
|
47 days
Interval 35.0 to 61.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Assessed from the date of the first dose of study drug to date of death from any cause, assessed up to 9 monthsPopulation: No subjects were treated in the Dose Escalation Phase, Cohort 1a. Death dates reported for 2 of 3 subjects in Cohort 1b. The Expansion Phase did not open.
Length of time from the date of first dose of study drug to date of death from any cause
Outcome measures
| Measure |
Dose Escalation Phase, Cohort 1b: VIC-1911 Plus Sotorasib Combination Therapy
n=2 Participants
Subjects with locally advanced or metastatic KRAS G12C-mutated NSCLC refractory to or relapsed on prior KRASG12C inhibitor therapy or are naive to KRAS G12C inhibitor therapy will receive VIC-1911 plus sotorasib combination therapy.
VIC-1911: VIC-1911 tablets for oral administration
sotorasib: Sotorasib tablets for oral administration
Only Dose Level 1 was opened and all 3 subjects received sotorasib 960 mg QD PO, VIC-1911 75 mg BID PO.
|
Expansion Phase, Cohort 2a: VIC-1911 Monotherapy
Subjects with locally advanced or metastatic KRAS G12C-mutated NSCLC refractory to or relapsed on prior KRASG12C inhibitor therapy will receive VIC-1911 monotherapy.
VIC-1911: VIC-1911 tablets for oral administration
|
Expansion Phase, Cohort 2b: VIC-1911 Plus Sotorasib Combination Therapy
Subjects with locally advanced or metastatic KRAS G12C-mutated NSCLC refractory to or relapsed on prior KRASG12C inhibitor therapy will receive VIC-1911 plus sotorasib combination therapy.
VIC-1911: VIC-1911 tablets for oral administration
sotorasib: Sotorasib tablets for oral administration
|
Dose Escalation Phase, Cohort 1a: VIC-1911 Monotherapy
Subjects with locally advanced or metastatic KRAS G12C-mutated NSCLC refractory to or relapsed on prior KRASG12C inhibitor therapy will receive VIC-1911 monotherapy.
VIC-1911: VIC-1911 tablets for oral administration
|
Expansion Phase, Cohort 2c: VIC-1911 Plus Sotorasib Combination Therapy
Subjects with locally advanced or metastatic KRAS G12C-mutated NSCLC naive to KRAS G12C inhibitor therapy will receive VIC-1911 plus sotorasib combination therapy.
VIC-1911: VIC-1911 tablets for oral administration
sotorasib: Sotorasib tablets for oral administration
|
|---|---|---|---|---|---|
|
Overall Survival
|
86 days
Interval 47.0 to 125.0
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Was to be assessed C1D1; C1D15; C2D1; C4D1; C6D1 (each cycle is 28 days). The study terminated early with only 3 subjects analyzed C1D1 and 2 subjects analyzed C1D15.Population: No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
Mean plasma concentrations of VIC-1911 will be determined and summarized by dose group.
Outcome measures
| Measure |
Dose Escalation Phase, Cohort 1b: VIC-1911 Plus Sotorasib Combination Therapy
n=3 Participants
Subjects with locally advanced or metastatic KRAS G12C-mutated NSCLC refractory to or relapsed on prior KRASG12C inhibitor therapy or are naive to KRAS G12C inhibitor therapy will receive VIC-1911 plus sotorasib combination therapy.
VIC-1911: VIC-1911 tablets for oral administration
sotorasib: Sotorasib tablets for oral administration
Only Dose Level 1 was opened and all 3 subjects received sotorasib 960 mg QD PO, VIC-1911 75 mg BID PO.
|
Expansion Phase, Cohort 2a: VIC-1911 Monotherapy
Subjects with locally advanced or metastatic KRAS G12C-mutated NSCLC refractory to or relapsed on prior KRASG12C inhibitor therapy will receive VIC-1911 monotherapy.
VIC-1911: VIC-1911 tablets for oral administration
|
Expansion Phase, Cohort 2b: VIC-1911 Plus Sotorasib Combination Therapy
Subjects with locally advanced or metastatic KRAS G12C-mutated NSCLC refractory to or relapsed on prior KRASG12C inhibitor therapy will receive VIC-1911 plus sotorasib combination therapy.
VIC-1911: VIC-1911 tablets for oral administration
sotorasib: Sotorasib tablets for oral administration
|
Dose Escalation Phase, Cohort 1a: VIC-1911 Monotherapy
Subjects with locally advanced or metastatic KRAS G12C-mutated NSCLC refractory to or relapsed on prior KRASG12C inhibitor therapy will receive VIC-1911 monotherapy.
VIC-1911: VIC-1911 tablets for oral administration
|
Expansion Phase, Cohort 2c: VIC-1911 Plus Sotorasib Combination Therapy
Subjects with locally advanced or metastatic KRAS G12C-mutated NSCLC naive to KRAS G12C inhibitor therapy will receive VIC-1911 plus sotorasib combination therapy.
VIC-1911: VIC-1911 tablets for oral administration
sotorasib: Sotorasib tablets for oral administration
|
|---|---|---|---|---|---|
|
Mean Plasma Concentrations of VIC-1911 Alone and in Combination With Sotorasib
C1D1
|
2190 ng/mL
Standard Deviation 2090
|
—
|
—
|
—
|
—
|
|
Mean Plasma Concentrations of VIC-1911 Alone and in Combination With Sotorasib
C1D15
|
2120 ng/mL
Standard Deviation 0
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Cycle 1 Day 1 pre-dose and at progression of diseasePopulation: No data displayed because circulating tumor DNA was not collected for this Outcome Measure for any participant.
Changes from baseline will be determined, summarized by dose group and correlated with clinical outcome
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Pre-study, Cycle 3 Day 1, and at progression of diseasePopulation: No data displayed because tumor biopsies for this Outcome Measure were not collected for any participant.
Changes from baseline will be determined, summarized by dose group and correlated with clinical outcome
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 42 monthsPopulation: No data displayed because Outcome Measure had zero participants with clinical outcome CR, PR or SD.
The effect of prior KRAS G12C de novo resistance (KRAS G12C inhibitor treatment ≤ 3 months) versus KRAS G12C acquired resistance (KRAS G12C inhibitor treatment \> 3 months) on clinical outcome
Outcome measures
Outcome data not reported
Adverse Events
Dose Escalation Phase, Cohort 1a: VIC-1911 Monotherapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Dose Escalation Phase, Cohort 1b: VIC-1911 Plus Sotorasib Combination Therapy
Serious events: 2 serious events
Other events: 3 other events
Deaths: 2 deaths
Expansion Phase, Cohort 2a: VIC-1911 Monotherapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Expansion Phase, Cohort 2b: VIC-1911 Plus Sotorasib Combination Therapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Expansion Phase, Cohort 2c: VIC-1911 Plus Sotorasib Combination Therapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dose Escalation Phase, Cohort 1a: VIC-1911 Monotherapy
Subjects with locally advanced or metastatic KRAS G12C-mutated NSCLC refractory to or relapsed on prior KRASG12C inhibitor therapy will receive VIC-1911 monotherapy.
VIC-1911: VIC-1911 tablets for oral administration
|
Dose Escalation Phase, Cohort 1b: VIC-1911 Plus Sotorasib Combination Therapy
n=3 participants at risk
Subjects with locally advanced or metastatic KRAS G12C-mutated NSCLC refractory to or relapsed on prior KRASG12C inhibitor therapy or are naive to KRAS G12C inhibitor therapy will receive VIC-1911 plus sotorasib combination therapy.
VIC-1911: VIC-1911 tablets for oral administration
sotorasib: Sotorasib tablets for oral administration
Only Dose Level 1 was opened and all 3 subjects received sotorasib 960 mg QD PO, VIC-1911 75 mg BID PO.
|
Expansion Phase, Cohort 2a: VIC-1911 Monotherapy
Subjects with locally advanced or metastatic KRAS G12C-mutated NSCLC refractory to or relapsed on prior KRASG12C inhibitor therapy will receive VIC-1911 monotherapy.
VIC-1911: VIC-1911 tablets for oral administration
|
Expansion Phase, Cohort 2b: VIC-1911 Plus Sotorasib Combination Therapy
Subjects with locally advanced or metastatic KRAS G12C-mutated NSCLC refractory to or relapsed on prior KRASG12C inhibitor therapy will receive VIC-1911 plus sotorasib combination therapy.
VIC-1911: VIC-1911 tablets for oral administration
sotorasib: Sotorasib tablets for oral administration
|
Expansion Phase, Cohort 2c: VIC-1911 Plus Sotorasib Combination Therapy
Subjects with locally advanced or metastatic KRAS G12C-mutated NSCLC naive to KRAS G12C inhibitor therapy will receive VIC-1911 plus sotorasib combination therapy.
VIC-1911: VIC-1911 tablets for oral administration
sotorasib: Sotorasib tablets for oral administration
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
—
0/0 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
33.3%
1/3 • Number of events 1 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
—
0/0 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
—
0/0 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
—
0/0 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
|
Infections and infestations
Pneumonia
|
—
0/0 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
33.3%
1/3 • Number of events 1 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
—
0/0 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
—
0/0 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
—
0/0 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
|
Vascular disorders
Embolism
|
—
0/0 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
33.3%
1/3 • Number of events 1 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
—
0/0 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
—
0/0 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
—
0/0 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
Other adverse events
| Measure |
Dose Escalation Phase, Cohort 1a: VIC-1911 Monotherapy
Subjects with locally advanced or metastatic KRAS G12C-mutated NSCLC refractory to or relapsed on prior KRASG12C inhibitor therapy will receive VIC-1911 monotherapy.
VIC-1911: VIC-1911 tablets for oral administration
|
Dose Escalation Phase, Cohort 1b: VIC-1911 Plus Sotorasib Combination Therapy
n=3 participants at risk
Subjects with locally advanced or metastatic KRAS G12C-mutated NSCLC refractory to or relapsed on prior KRASG12C inhibitor therapy or are naive to KRAS G12C inhibitor therapy will receive VIC-1911 plus sotorasib combination therapy.
VIC-1911: VIC-1911 tablets for oral administration
sotorasib: Sotorasib tablets for oral administration
Only Dose Level 1 was opened and all 3 subjects received sotorasib 960 mg QD PO, VIC-1911 75 mg BID PO.
|
Expansion Phase, Cohort 2a: VIC-1911 Monotherapy
Subjects with locally advanced or metastatic KRAS G12C-mutated NSCLC refractory to or relapsed on prior KRASG12C inhibitor therapy will receive VIC-1911 monotherapy.
VIC-1911: VIC-1911 tablets for oral administration
|
Expansion Phase, Cohort 2b: VIC-1911 Plus Sotorasib Combination Therapy
Subjects with locally advanced or metastatic KRAS G12C-mutated NSCLC refractory to or relapsed on prior KRASG12C inhibitor therapy will receive VIC-1911 plus sotorasib combination therapy.
VIC-1911: VIC-1911 tablets for oral administration
sotorasib: Sotorasib tablets for oral administration
|
Expansion Phase, Cohort 2c: VIC-1911 Plus Sotorasib Combination Therapy
Subjects with locally advanced or metastatic KRAS G12C-mutated NSCLC naive to KRAS G12C inhibitor therapy will receive VIC-1911 plus sotorasib combination therapy.
VIC-1911: VIC-1911 tablets for oral administration
sotorasib: Sotorasib tablets for oral administration
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
—
0/0 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
33.3%
1/3 • Number of events 1 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
—
0/0 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
—
0/0 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
—
0/0 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
|
Cardiac disorders
Sinus tachycardia
|
—
0/0 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
33.3%
1/3 • Number of events 1 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
—
0/0 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
—
0/0 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
—
0/0 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
|
Eye disorders
Vision blurred
|
—
0/0 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
33.3%
1/3 • Number of events 1 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
—
0/0 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
—
0/0 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
—
0/0 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
|
Gastrointestinal disorders
Abdominal distension
|
—
0/0 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
33.3%
1/3 • Number of events 1 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
—
0/0 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
—
0/0 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
—
0/0 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
|
Gastrointestinal disorders
Diarrhea
|
—
0/0 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
33.3%
1/3 • Number of events 1 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
—
0/0 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
—
0/0 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
—
0/0 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
|
Gastrointestinal disorders
Nausea
|
—
0/0 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
33.3%
1/3 • Number of events 1 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
—
0/0 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
—
0/0 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
—
0/0 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
|
General disorders
Chest pain
|
—
0/0 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
33.3%
1/3 • Number of events 1 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
—
0/0 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
—
0/0 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
—
0/0 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
|
General disorders
Fatigue
|
—
0/0 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
33.3%
1/3 • Number of events 1 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
—
0/0 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
—
0/0 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
—
0/0 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
|
General disorders
Edema, peripheral
|
—
0/0 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
33.3%
1/3 • Number of events 1 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
—
0/0 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
—
0/0 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
—
0/0 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
|
General disorders
Noncardiac chest pain
|
—
0/0 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
33.3%
1/3 • Number of events 1 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
—
0/0 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
—
0/0 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
—
0/0 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
|
General disorders
Pain
|
—
0/0 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
33.3%
1/3 • Number of events 1 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
—
0/0 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
—
0/0 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
—
0/0 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
—
0/0 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
33.3%
1/3 • Number of events 1 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
—
0/0 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
—
0/0 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
—
0/0 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
|
Investigations
Blood alkaline phosphatase increased
|
—
0/0 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
33.3%
1/3 • Number of events 1 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
—
0/0 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
—
0/0 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
—
0/0 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
|
Investigations
Alanine aminotransferase increased
|
—
0/0 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
33.3%
1/3 • Number of events 1 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
—
0/0 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
—
0/0 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
—
0/0 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
|
Investigations
Aspartate aminotransferase increased
|
—
0/0 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
33.3%
1/3 • Number of events 1 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
—
0/0 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
—
0/0 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
—
0/0 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
|
Investigations
International normalized ratio increased
|
—
0/0 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
33.3%
1/3 • Number of events 1 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
—
0/0 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
—
0/0 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
—
0/0 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
|
Investigations
Lymphocyte count decreased
|
—
0/0 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
33.3%
1/3 • Number of events 1 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
—
0/0 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
—
0/0 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
—
0/0 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
|
Investigations
Weight decreased
|
—
0/0 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
33.3%
1/3 • Number of events 1 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
—
0/0 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
—
0/0 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
—
0/0 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
|
Investigations
White blood cell count increased
|
—
0/0 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
33.3%
1/3 • Number of events 1 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
—
0/0 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
—
0/0 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
—
0/0 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
—
0/0 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
33.3%
1/3 • Number of events 1 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
—
0/0 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
—
0/0 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
—
0/0 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
—
0/0 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
33.3%
1/3 • Number of events 1 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
—
0/0 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
—
0/0 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
—
0/0 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
—
0/0 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
33.3%
1/3 • Number of events 1 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
—
0/0 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
—
0/0 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
—
0/0 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
—
0/0 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
33.3%
1/3 • Number of events 1 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
—
0/0 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
—
0/0 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
—
0/0 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
—
0/0 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
33.3%
1/3 • Number of events 1 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
—
0/0 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
—
0/0 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
—
0/0 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
—
0/0 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
33.3%
1/3 • Number of events 1 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
—
0/0 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
—
0/0 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
—
0/0 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
|
Nervous system disorders
Dizziness
|
—
0/0 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
33.3%
1/3 • Number of events 1 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
—
0/0 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
—
0/0 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
—
0/0 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
—
0/0 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
33.3%
1/3 • Number of events 1 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
—
0/0 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
—
0/0 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
—
0/0 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
—
0/0 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
33.3%
1/3 • Number of events 1 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
—
0/0 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
—
0/0 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
—
0/0 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
—
0/0 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
33.3%
1/3 • Number of events 1 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
—
0/0 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
—
0/0 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
—
0/0 • 9 months
No subjects were treated in the Dose Escalation Phase, Cohort 1a. The Expansion Phase did not open.
|
Additional Information
Linda Paradiso, DVM, Chief Development Officer
VITRAC Therapeutics, LLC
Phone: 713-898-8965
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place