Phase 1b, Multicenter, Open-label, Dose Escalation and Dose Expansion Study of RMC-6291 in Combination with RMC-6236 in Participants with Advanced KRASG12C-Mutated Solid Tumors
Trial Description
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 Requirements
Inclusion Criteria:
- 18 years of age
- Histology: pathologically documented, KRAS G12C-mutated, advanced or metastatic
solid tumors not amendable to curative therapy
1. Part 1. Dose Escalation: solid tumors, previously treated
2. Part 2. Dose Expansion:
i. 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:
- 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