Clinical Trial 24071

• Overview

  Study Title:

  Phase 1/1b, Multicenter, Open-Label, Study of RMC-5127 in Patients with Advanced KRAS G12V-Mutant Solid Tumors

  Summary:

  The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of RMC-5127 as a monotherapy and in combination with either daraxonrasib or cetuximab in adults with KRAS G12V-mutant solid tumors.

  Objective:

  Primary Objectives: * To evaluate the safety and tolerability of RMC-5127 monotherapy in patients with KRAS G12V-mutant solid tumors. * To define the MTD and/or RP2DS for RMC-5127 monotherapy in adults with KRAS G12V-mutant solid tumors. Secondary Objectives: *To characterize the whole blood PK of RMC-5127 after single- and repeat-dose administration. *To evaluate preliminary antitumor effects of RMC-5127 monotherapy in KRAS G12V-mutant solid tumors. *To evaluate the effect of food on the PK of RMC-5127 monotherapy.

• Treatments

  Therapies:

  RAS inhibitor; RAS(OFF) inhibitors; RASG12V Inhibitor

  Medications:

  Cetuximab (); Daraxonrasib (); Erbitux (Cetuximab); RMC-5127 (); RMC-6236 (Daraxonrasib)

• Inclusion Criteria

  Key Inclusion Criteria:
  • At least 18 years old and has provided informed consent.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Pathologically documented, locally advanced or metastatic KRAS G12V-mutated solid tumor malignancy.
  • Received and progressed or been intolerant to prior standard therapy (including targeted therapy) appropriate for tumor type and stage.
  • Measurable per RECIST v1.1
  • Adequate organ function (bone marrow, liver, kidney, coagulation).
  • Able to take oral medications.

• Exclusion Criteria

  Key Exclusion Criteria:
  • Primary central nervous system (CNS) tumors
  • Prior therapy with KRAS G12V inhibitor or direct RAS-targeted therapy (eg. degraders and/or inhibitors).
  • Any conditions that may affect the ability to take or absorb study drug.
  • Major surgery within 28 days prior to receiving study drug(s).
  • Patient is unable or unwilling to comply with protocol-required study visits or procedures.

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