Study of RMC-9805 in Participants With KRAS G12D-Mutant Solid Tumors
Recruiting · NCT06040541 · Interventional (participants receive a specific treatment) · Lead sponsor: Revolution Medicines, Inc.
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
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)
- ther inclusion/exclusion criteria may apply.
Where it is running
17 locations listed across 11 US states.
- University of California, Davis Comprehensive Cancer Center - Sacramento, California, United States
- Smilow Cancer Hospital (Yale University) - New Haven, Connecticut, United States
- Florida Cancer Specialists - Sarasota, Florida, United States
- Lee Moffitt Cancer Center - Tampa, Florida, United States
- Johns Hopkins University - Baltimore, Maryland, United States
- Massachusetts General Hospital - Boston, Massachusetts, United States
- Dana-Farber Cancer Institute - Boston, Massachusetts, United States
- NYU Langone - New York, New York, United States
- Memorial Sloan Kettering Cancer Center - New York, New York, United States
- Duke Cancer Center - Durham, North Carolina, United States
- Carolina BioOncology Institute - Huntersville, North Carolina, United States
- The Christ Hospital - Cincinnati, Ohio, United States
- Sarah Cannon Research Institute - Nashville, Tennessee, United States
- Sarah Cannon Research Institute at Mary Crowley - Dallas, Texas, United States
- University of Texas, MD Anderson Cancer Center - Houston, Texas, United States
- START - San Antonio, Texas, United States
- NEXT Oncology Virginia - Fairfax, Virginia, United States