Study of Elironrasib and Daraxonrasib as Monotherapies and Combination Therapy in Participants With Advanced KRAS G12C Mutant Solid Tumors
Trial Parameters
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Brief Summary
This study is to evaluate the safety, tolerability, and PK profiles of Elironrasib and Daraxonrasib as monotherapies and combination therapy in patients with KRAS G12C-mutated solid tumors.
Eligibility Criteria
Inclusion Criteria: * 18 years of age * Histology: pathologically documented, KRAS G12C-mutated, advanced or metastatic solid tumors not amendable to curative therapy 1. Phase 1b Dose Escalation: solid tumors, previously treated 2. Phase 1b Dose Expansion and Phase 2: i. NSCLC, previously treated with immunotherapy, chemotherapy, and KRAS G12C (OFF) inhibitors ii. Solid tumors, previously treated, naïve to KRAS G12C (OFF) inhibitors. * ECOG performance status 0 or 1 * Adequate organ function Exclusion Criteria: * Primary central nervous system (CNS) tumors * Active brain metastases * Known impairment of GI function that would alter the absorption * Major surgical procedures within 28 days or non-study related minor procedures within 7 days of treatment