RecruitingPhase 1NCT06040541

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

Phase 1/1b, Multicenter, Open-Label, Study of RMC 9805 in Participants With Advanced KRASG 12D-Mutant Solid Tumors


Sponsor

Revolution Medicines, Inc.

Enrollment

604 participants

Start Date

Sep 7, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • 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 Criteria4

  • 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)

Interventions

DRUGRMC-9805

Oral Tablets

DRUGRMC-6236

Oral Tablets


Locations(17)

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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06040541


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