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Study of RMC-9805 in Participants With KRAS G12D-Mutant Solid Tumors
NCT06040541 · Revolution Medicines, Inc.
In plain English
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Official title
Phase 1/1b, Multicenter, Open-Label, Study of RMC 9805 in Participants With Advanced KRASG 12D-Mutant Solid Tumors
About this study
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, tolerability, pharmacokinetics (PK), and preliminary clinical activity. The study consists of two arms: RMC-9805 monotherapy arm and RMC-9805 plus RMC-6236 combination arm. Both arms consist of two parts: Part 1- dose exploration and Part 2- dose expansion.
Eligibility criteria
Inclusion Criteria:
* 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 Criteria:
* 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.
Study design
Enrollment target: 604 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2023-09-07
Estimated completion: 2027-04-30
Last updated: 2025-08-28
Interventions
Drug: RMC-9805Drug: RMC-6236
Primary outcomes
- • Adverse events (Up to 3 years)
- • Dose Limiting Toxicities (21 days)
Sponsor
Revolution Medicines, Inc. · industry
Contacts & investigators
ContactRevolution Medicines, Inc. · contact · medinfo@RevMed.com · 1-844-2-REVMED
InvestigatorRevolution Medicines, Inc. · study_director, Revolution Medicines, Inc.
All locations (17)
University of California, Davis Comprehensive Cancer CenterRecruiting
Sacramento, California, United States
Smilow Cancer Hospital (Yale University)Recruiting
New Haven, Connecticut, United States
Florida Cancer SpecialistsRecruiting
Sarasota, Florida, United States
Lee Moffitt Cancer CenterRecruiting
Tampa, Florida, United States
Johns Hopkins UniversityRecruiting
Baltimore, Maryland, United States
Massachusetts General HospitalRecruiting
Boston, Massachusetts, United States
Dana-Farber Cancer InstituteRecruiting
Boston, Massachusetts, United States
NYU LangoneRecruiting
New York, New York, United States
Memorial Sloan Kettering Cancer CenterRecruiting
New York, New York, United States
Duke Cancer CenterRecruiting
Durham, North Carolina, United States
Carolina BioOncology InstituteRecruiting
Huntersville, North Carolina, United States
The Christ HospitalRecruiting
Cincinnati, Ohio, United States
Sarah Cannon Research InstituteRecruiting
Nashville, Tennessee, United States
Sarah Cannon Research Institute at Mary CrowleyRecruiting
Dallas, Texas, United States
University of Texas, MD Anderson Cancer CenterRecruiting
Houston, Texas, United States
STARTRecruiting
San Antonio, Texas, United States
NEXT Oncology VirginiaRecruiting
Fairfax, Virginia, United States