About this trial

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 criteria

Qualifiers

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

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • RMC-9805
  • RMC-6236

Treatment groups

604 Participants
are divided into 2 treatment groups

Locations

17
California
University of California, Davis Comprehensive Cancer Center95817, Sacramento United States
Connecticut
Smilow Cancer Hospital (Yale University)06511, New Haven United States
Florida
Florida Cancer Specialists34232, Sarasota United States
Lee Moffitt Cancer Center33612, Tampa United States

Sponsors and collaborators

Revolution Medicines, Inc.

Lead sponsor