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Phase 1Recruiting

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

Sponsored by Revolution Medicines, Inc.

About this study

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.

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.

Where this study is enrolling

  • University of Texas, MD Anderson Cancer Center

    Houston, Texas

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Who can participate

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.

Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.

Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.

Trial data sourced from ClinicalTrials.gov.