Phase I-II
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:05/25/2023
To evaluate the safety and tolerability of sotorasib administered in investigational regimens in adult subjects with KRAS p.G12C mutant advanced solid tumors.
Contact Us
For more information about this study, including how to volunteer, contact:
Jennifer Pope
- Phone Number: 1-203-737-5801
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You can help our team find trials you might be eligible for by creating a volunteer profile in MyChart. To get started, create a volunteer profile, or contact helpusdiscover@yale.edu, or call +18779788343 for more information.
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.
