Evaluating RMC-9805 for KRAS G12D-Mutant Solid Tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• University of California, Davis Comprehensive Cancer Center
  Sacramento, California, United States Recruiting
• Smilow Cancer Hospital (Yale University)
  New Haven, Connecticut, United States Recruiting
• Florida Cancer Specialists
  Sarasota, Florida, United States Recruiting
• Lee Moffitt Cancer Center
  Tampa, Florida, United States Recruiting
• Johns Hopkins University
  Baltimore, Maryland, United States Recruiting
• Massachusetts General Hospital
  Boston, Massachusetts, United States Recruiting

Study contacts

• Study coordinator: Revolution Medicines, Inc.
• Email: medinfo@RevMed.com
• Phone: 1-844-2-REVMED

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• RMC-5127 for advanced cancers with KRAS G12V mutation

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• Evaluating RMC-6236 for advanced solid tumors with specific RAS mutations

  This study is testing a new drug called RMC-6236 to see if it can help adults with advanced solid tumors that have certain RAS mutations.

  Recruiting at 21 sites Phase 1/2 Revolution Medicines, Inc. · Orange, California and 20 other locations · NCT05379985

• Combining RAS(ON) inhibitors with ivonescimab for adults with RAS‑mutant advanced solid tumors

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• BMS-986523 alone and with other cancer medicines for advanced KRAS-altered solid tumors

  This treatment tests whether BMS-986523, alone or combined with chemotherapy or immunotherapy, helps people with advanced KRAS-altered lung, colorectal, or pancreatic cancers.

  Recruiting at 6 sites Phase 1/2 Bristol-Myers Squibb · Baltimore, Maryland and 7 other locations · NCT07223047

• JYP0015 for adults with advanced RAS‑mutant solid tumors

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  Recruiting Phase 2 Guangzhou JOYO Pharma Co., Ltd · Beijing, Beijing Municipality · NCT06895031

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.