AMG 510 (pINN) Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101) (Amgen 20190135 Subprotocol E)
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
To evaluate the safety and tolerability of sotorasib administered in investigational regimens in adult subjects with KRAS p.G12C mutant advanced solid tumors.
Key Inclusion Criteria
For a patient to be eligible for participation in this study, all of the following criteria must apply.
- 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.
Key Exclusion Criteria
A patient will not be eligible for participation in this study if any of the following criteria apply.
- 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.
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