Phase I
A Phase 1b, Protocol Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 510 (pINN) Sotorasib Monotherapy and in Combination With Other Anti-cancer Therapies in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101)
- Study HIC#:2000026544
- Last Updated:07/12/2022
To evaluate the safety and tolerability of sotorasib administered in investigational regimens in adult subjects with KRAS p.G12C mutant advanced solid tumors.
- Start Date01/14/2022
- End Date08/26/2024
Trial Purpose and Description
Primary Outcome Measures :
- Number of Participants with Dose Limiting Toxicities (DLTs) [ Time Frame: 12 months ]
- Number of Participants with Treatment-emergent Adverse Events (TEAEs) [ Time Frame: 12 months ]
- Number of Participants with Treatment-related Adverse Events [ Time Frame: 12 months ]
- Number of Participants with Clinically Significant Changes in Vital Signs. [ Time Frame: 12 months ]
- Number of Participants with Clinically Significant Changes of ECG Measurement [ Time Frame: 12 months ]
- Number of Participants with Clinically Significant Laboratory Values [ Time Frame: 12 months ]
Secondary Outcome Measures :
- Maximum Plasma Concentration (Cmax) [ Time Frame: 12 months ]
- Time to Maximum Plasma Concentration (Tmax) [ Time Frame: 12 months ]
- Area Under the Plasma Concentration-time Curve (AUC) [ Time Frame: 12 months ]
- Disease Control Rate [ Time Frame: 12 months ]
- Duration of Response [ Time Frame: 12 Months ]
- Progression-free Survival [ Time Frame: 12 months ]
- Duration of Stable Disease [ Time Frame: 12 Months ]
- Objective Response Rate [ Time Frame: 12 months ]
- Time to Response [ Time Frame: 12 Months ]
- Overall Survival [ Time Frame: 12 Months ]
Eligibility Criteria
Inclusion Criteria:
- Men or women greater than or equal to 18 years old.
- Pathologically documented, locally-advanced or metastatic malignancy with, KRAS p.G12C mutation identified through molecular testing.
Exclusion Criteria:
- Primary brain tumor.
- Spinal cord compression, or untreated, or symptomatic, or active brain metastases, or leptomeningeal disease from non-brain tumors.
- Myocardial infarction within 6 months of study day 1.
- Gastrointestinal (GI) tract disease causing the inability to take oral medication.