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Evaluating RMC-9805 for KRAS G12D-Mutant Solid Tumors

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

PHASE1 · Revolution Medicines, Inc. · NCT06040541

This study is testing a new drug called RMC-9805 to see if it can safely help adults with solid tumors that have a specific KRAS G12D mutation.

Quick facts

PhasePHASE1
Study typeInterventional
Enrollment604 (estimated)
Ages18 Years and up
SexAll
SponsorRevolution Medicines, Inc. (industry)
Locations17 sites (Sacramento, California and 16 other locations)
Trial IDNCT06040541 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and tolerability of RMC-9805, a selective KRAS G12D inhibitor, in adults with solid tumors harboring the KRAS G12D mutation. It is an open-label, multicenter Phase 1/1b trial that includes two arms: one for RMC-9805 as a monotherapy and another for RMC-9805 in combination with RMC-6236. The study will assess pharmacokinetics and preliminary clinical activity through dose exploration and expansion phases.

Who should consider this trial

Good fit: Ideal candidates include adults with locally advanced or metastatic solid tumors that have a KRAS G12D mutation and have progressed on or been intolerant to prior therapies.

Not a fit: Patients with primary CNS tumors, active brain metastases, or those previously treated with KRAS G12D inhibitors may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new targeted therapy option for patients with KRAS G12D-mutant solid tumors.

How similar studies have performed: Other studies targeting KRAS mutations have shown promise, indicating potential for success with this novel approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Sacramento, California and 16 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Non-small Cell Lung Cancer, Colorectal Cancer, Pancreatic Ductal Adenocarcinoma, Advanced Solid Tumors, KRAS G12D, NSCLC, CRC, PDAC

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.