Status:
RECRUITING
Study of RMC-9805 in Participants With KRAS G12D-Mutant Solid Tumors
Lead Sponsor:
Revolution Medicines, Inc.
Conditions:
Non-small Cell Lung Cancer (NSCLC)
Colorectal Cancer (CRC)
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This study is to evaluate the safety and tolerability of RMC-9805 as monotherapy and in combination with RMC-6236 in adults with KRAS G12D-mutant solid tumors.
Detailed Description
This is an open-label, multicenter, Phase 1/1b study of RMC-9805, a selective and orally bioavailable KRAS G12D(ON) inhibitor, in subjects with KRASG12D-mutant solid tumors to evaluate the safety, tol...
Eligibility Criteria
Inclusion
- Pathologically documented, locally advanced or metastatic solid tumor with a KRAS G12D-mutation
- Received and progressed or been intolerant to prior standard therapy (including targeted therapy) appropriate for tumor type and stage
- ECOG performance status 0 or 1
- Adequate organ function
Exclusion
- Primary central nervous system (CNS) tumors
- Known or suspected leptomeningeal or active brain metastases or spinal cord compression
- Known or suspected impairment of gastrointestinal function that may prohibit ability to swallow or absorb an oral medication
- Participant was previously treated with an investigational KRAS G12D inhibitor, pan- or multi-RAS inhibitor, or had prior therapy with any direct RAS-targeted therapy (eg, degraders and inhibitors)
- Other inclusion/exclusion criteria may apply.
Key Trial Info
Start Date :
September 7 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2027
Estimated Enrollment :
604 Patients enrolled
Trial Details
Trial ID
NCT06040541
Start Date
September 7 2023
End Date
April 30 2027
Last Update
August 28 2025
Active Locations (17)
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1
University of California, Davis Comprehensive Cancer Center
Sacramento, California, United States, 95817
2
Smilow Cancer Hospital (Yale University)
New Haven, Connecticut, United States, 06511
3
Florida Cancer Specialists
Sarasota, Florida, United States, 34232
4
Lee Moffitt Cancer Center
Tampa, Florida, United States, 33612