Study of RMC-9805 in Participants With KRAS G12D-Mutant Solid Tumors

Recruiting now · Phase 1

Conditions studied: Non-small Cell Lung Cancer (NSCLC), Colorectal Cancer (CRC), Pancreatic Ductal Adenocarcinoma (PDAC), Advanced Solid Tumors

In brief

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.

Key facts

Study ID

NCT06040541

Run by

Revolution Medicines, Inc.

People needed

604

Starts

2023-09-07

Expected to finish

2027-04-30

Last updated by the study team

2026-06-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• University of California, Davis Comprehensive Cancer Center — Sacramento, California, United States (enrolling)
• Smilow Cancer Hospital (Yale University) — New Haven, Connecticut, United States (enrolling)
• Florida Cancer Specialists — Sarasota, Florida, United States (enrolling)
• Lee Moffitt Cancer Center — Tampa, Florida, United States (enrolling)
• Johns Hopkins University — Baltimore, Maryland, United States (enrolling)
• Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States (enrolling)
• NYU Langone — New York, New York, United States (enrolling)
• Memorial Sloan Kettering Cancer Center — New York, New York, United States (enrolling)
• Duke Cancer Center — Durham, North Carolina, United States (enrolling)
• Carolina BioOncology Institute — Huntersville, North Carolina, United States (enrolling)
• The Christ Hospital — Cincinnati, Ohio, United States (enrolling)
• Sarah Cannon Research Institute — Nashville, Tennessee, United States (enrolling)
• Sarah Cannon Research Institute at Mary Crowley — Dallas, Texas, United States (enrolling)
• University of Texas, MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
• START — San Antonio, Texas, United States (enrolling)
• NEXT Oncology Virginia — Fairfax, Virginia, United States (enrolling)

Full record on ClinicalTrials.gov

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