Evaluate the safety and tolerability of sotorasib in adult subjects with KRAS p.G12C mutant advanced solid tumors. Estimate the maximum tolerated dose (MTD) and/or a recommended phase 2 dose (RP2D) in adult subjects with KRAS p.G12C mutant advanced solid tumors.
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Primary: Number of subjects with treatment-emergent adverse events
Timeframe: 24 Months
Primary: Number of subjects with treatment-related adverse events
Timeframe: 24 Months
Primary: Number of subjects with grade ≥3 treatment-emergent adverse events
Timeframe: 24 Months
Primary: Number of subjects with serious adverse events
Timeframe: 24 Months
Primary: Number of subjects with adverse events of interest
Timeframe: 24 Months
Primary: Number of subjects with clinically significant changes in vital signs
Timeframe: Baseline to 24 Months
Primary: Number of subjects with clinically significant changes in physical examination results
Timeframe: Baseline to 24 Months
Primary: Number of subjects with clinically significant changes on electrocardiograms (ECGs)
Timeframe: Baseline to 24 Months
Primary: Number of subjects with clinically significant changes in clinical laboratory values
Timeframe: Baseline to 24 Months
Primary: Number of subjects with dose-limiting toxicities (DLTs)
Timeframe: 21 Days
Primary: Objective response rate (ORR) as assessed by RECIST 1.1 criteria
Timeframe: 24 Months
Primary: Duration of response (DOR) as assessed by RECIST 1.1 criteria
Timeframe: 24 Months
Primary: Disease control as assessed by RECIST 1.1 criteria
Timeframe: 24 Months
Primary: Duration of stable disease (SD) as assessed by RECIST 1.1 criteria
Timeframe: 24 Months
Primary: Time to response (TTR) as assessed by RECIST 1.1 criteria
Timeframe: 24 Months