Status:
RECRUITING
Study of RMC-6291 in Combination with RMC-6236 in Participants with Advanced KRAS G12C Mutant Solid Tumors
Lead Sponsor:
Revolution Medicines, Inc.
Conditions:
Non-Small Cell Lung Cancer (NSCLC)
Colorectal Cancer
Eligibility:
All Genders
18-125 years
Phase:
PHASE1
Brief 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.
Detailed Description
This is an open-label, multicenter, Phase 1b study of RMC-6291 in combination with RMC-6236 in participants with advanced KRAS G12C-mutated solid tumors, to identify the maximum tolerated dose (MTD) a...
Eligibility Criteria
Inclusion
- 18 years of age
- Histology: pathologically documented, KRAS G12C-mutated, advanced or metastatic solid tumors not amendable to curative therapy
- Part 1. Dose Escalation: solid tumors, previously treated
- 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
- 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
Key Trial Info
Start Date :
November 14 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2026
Estimated Enrollment :
210 Patients enrolled
Trial Details
Trial ID
NCT06128551
Start Date
November 14 2023
End Date
November 30 2026
Last Update
March 27 2025
Active Locations (54)
Enter a location and click search to find clinical trials sorted by distance.
1
City of Hope
Duarte, California, United States, 91010
2
UC IRVINE Health
Orange, California, United States, 92868
3
UC Davis Comprehensive Cancer Center
Sacramento, California, United States, 95817
4
Stanford Cancer Institute
Stanford, California, United States, 94305