Clinical Trial 22685

• Overview

  Study Title:

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

  Summary:

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

  Objective:

  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

  Therapies:

  Therapy (NOS)

  Medications:

  RMC-6236 (); RMC-9805 ()

• 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.

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