Phase 1b, Multicenter, Open-Label, Dose Escalation and Dose Expansion Study of RMC-6291 in Combination with RMC-6236 in Participants with Advanced KRAS G12C-Mutated Solid Tumors
Details
This study is to evaluate the safety, tolerability, and PK profiles of RMC-6291 and RMC-6236 in adults with KRAS G12C-mutated solid tumors.
Eligibility
You can join if...
Please note this may not be a complete list of eligibility criteria. We have included a few examples of study criteria to help you better understand how your eligibility in the study will be determined; your study team will go through the study eligibility criteria with you to verify if you qualify for participation in this study
Inclusion Criteria:
18 years of age
Histology: pathologically, KRAS G12C-mutated, documented advanced or metastatic solid tumors not amendable to curative therapy
Part 1. Dose Escalation: solid tumors, previously treated
Part 2. Dose Expansion:
i.Non-small cell lung cancer (NSCLC), previously treated with immunotherapy, chemotherapy, and KRAS G12C (OFF) inhibitors,
ii. NSCLC, previously treated with immunotherapy and chemotherapy, naïve to KRAS G12C (OFF) inhibitors,
iii. NSCLC, previously treated with immunotherapy, chemotherapy, with untreated, asymptomatic central nervous system (CNS) metastases <2 cm in size
iv. Solid tumors, previously treated, naïve to KRAS G12C (OFF) inhibitors.
ECOG performance status 0 or 1
Adequate organ function
Exclusion Criteria:
i. Primary central nervous system (CNS) tumors
ii. Active brain metastases
iii. Known impairment of gastrointestinal function that would alter the absorption
iv. Major surgical procedures within 28 days or non-study related minor procedures within 7 days of treatment