Study of RMC-6291 in Combination With RMC-6236 in Participants With Advanced KRAS G12C Mutant Solid Tumors

• Status: Recruiting
• Trial end date: 2026-11-30
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Revolution Medicines, Inc.

Criteria

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