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RecruitingPhase 1

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests the safety of RMC-9805 alone and with RMC-6236, and how well people can tolerate them. It is for adults with solid tumors that have a gene change called KRAS G12D.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have a solid tumor confirmed by lab testing that has grown into nearby tissue or spread to other parts of the body.
  • The tumor has the KRAS G12D gene change.
  • Have had standard treatment for your cancer type and stage, including targeted treatment when appropriate. The cancer got worse, or you could not tolerate treatment.
  • Are fully active or can do light activities despite some limits on hard physical activity (ECOG score 0 or 1).
  • Your organs work well enough for the study.

Who can't join

  • Have a cancer that started in the brain or spinal cord.
  • Have known or suspected cancer in the lining around the brain or spinal cord, active cancer spread to the brain, or pressure on the spinal cord.
  • Have known or suspected digestive problems that may keep you from swallowing or absorbing medicine taken by mouth.
  • Have had an experimental KRAS G12D blocker, a drug that blocks several or all RAS proteins, or any other treatment that directly targets RAS proteins.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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.

Study sites (17)

CA

CT

FL

MA

MD

NC

NY

OH

TN

TX

VA