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  • Cancer Type: Multiple
  • Study Type: Treatment
  • NCT#: NCT06040541
  • Phase: Phase I
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  • Overview

    Study Title:

    Phase 1/1B, Multicenter, Open-Label, Study of RMC-9805 in Participants with Advanced KRASG12D-Mutant Solid Tumors


    This study is to evaluate the safety and tolerability of RMC-9805 in adults with KRAS G12D-mutant solid tumors.


    Primary Objectives * To evaluate the safety and tolerability of RMC-9805 monotherapy in adults with KRASG12D-mutant solid tumors. * To estimate the MTD and/or RP2DS for RMC-9805 monotherapy in adults with KRASG12D-mutant solid tumors. Secondary Objectives * To characterize the blood PK of RMC-9805 after single- and repeat-dose administration. * To evaluate preliminary anti-tumor effects of RMC-9805 monotherapy in KRASG12D-mutant solid tumors. * To evaluate the effect of food on the PK of RMC-9805 monotherapy.

  • Treatments


    Therapy (NOS)


    RMC-9805 ()

  • Inclusion Criteria

      Inclusion Criteria:
    • Pathologically documented, locally advanced or metastatic solid tumor malignancy with KRASG12D-mutations identified through deoxyribonucleic acid (DNA) sequencing or polymerase chain reaction (PCR) test
    • Received and progressed or been intolerant to prior standard therapy (including targeted therapy) appropriate for tumor type and stage
    • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
    • Adequate organ function
    • Other criteria may apply
  • Exclusion Criteria

      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 KRASG12D inhibitor or had prior therapy with any direct RAS-targeted therapy (eg, degraders and inhibitors)
    • Other criteria may apply

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