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.
Age range
18 Years – 100 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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