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

Study Identifier:
RMC-5127-001
CT.gov Identifier:
NCT07349537
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
N/A
Study Contact Information:
(210) 593-5651 or [email protected]
Recruiting

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Study 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.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Non-Small Cell Lung Cancer
  • Bowel (Colorectal)
  • Pancreas
  • Solid Tumor
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: EXPERIMENTAL: Arm A: RMC-5127 Monotherapy
    • Read More
  • Drug: Dose Escalation and Dose Expansion
  • Drug: Drug: RMC-5127
  • Drug: oral tablets
  • Drug: EXPERIMENTAL: Arm B: RMC-5127 + Daraxonrasib Combination
  • Drug: Drug: daraxonrasib
  • Drug: EXPERIMENTAL: Arm C: RMC-5127 + Cetuximab Combination
  • Drug: Drug: cetuximab
  • Drug: IV infusion
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruiting

    Requirements information
    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
    • 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.

    Clinical Study Information for Healthcare Providers

    By clicking the button below you will find in-depth information about this clinical trial, including study design, primary and secondary endpoints, and more. This information is intended for healthcare professionals seeking to review the scientific and operational aspects of the study.

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START San Antonio
    San Antonio, TX, United States, 78229
    Investigator
    Kyriakos Papadopoulos
    Status
    Recruiting
    Condition(s) Treated at Site
    Non-Small Cell Lung Cancer
    Bowel (Colorectal)
    Pancreas
    Solid Tumor
    Location
    START Midwest
    Grand Rapids, MI, United States, 49546
    Investigator
    Nehal Lakhani
    Status
    Recruiting
    Condition(s) Treated at Site
    Non-Small Cell Lung Cancer
    Bowel (Colorectal)
    Pancreas
    Solid Tumor