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  • Cancer Type: Thoracic
  • Study Type: Treatment
  • NCT#: NCT05462717
  • Phase: Phase I
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  • Overview

    Study Title:

    Phase 1/1b, Multicenter, Open-Label, Dose Escalation and Dose Expansion Study of RMC-6291 Monotherapy in Subjects with Advanced KRASG12C Mutant Solid Tumors


    The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of escalating doses of RMC-6291 (KRAS G12C(ON) inhibitor) monotherapy in adult subjects with advanced solid tumors and to identify the maximum tolerated dose (MTD), and the recommended Phase 2 dose.


    Primary Objectives: * To evaluate the safety and tolerability of RMC-6291 monotherapy in adult subjects with KRASG12C-mutant solid tumors. * To estimate the MTD and/or RP2DS for RMC-6291 monotherapy in adult subjects with KRASG12C-mutant solid tumors. Secondary Objectives: * To characterize the plasma PK of RMC-6291 after single- and repeat-dose administration. * To evaluate preliminary antitumor effects of RMC-6291 monotherapy in KRASG12C-mutant solid tumors.

  • Treatments


    Hormonal Therapy


    RMC-6291 ()

  • Inclusion Criteria

    • Patient must be >18 years of age.
    • Patient must have pathologically documented, locally advanced or metastatic KRASG12C-mutated solid tumor malignancy (not amenable to curative surgery) that has previously been treated with standard-of-care therapies for respective tumor types, is intolerant to, or is considered ineligible for standard-of-care anticancer treatments.
    • ECOG performance status 0 or 1
    • Prior treatment with a KRASG12C (OFF) inhibitor allowed for dose escalation
    • Adequate organ function
    • Other inclusion criteria may apply.
  • Exclusion Criteria

    • Primary central nervous system (CNS) tumors
    • Active brain metastases
    • Known impairment of GI function that would alter the absorption
    • Major surgical procedures within 28 days or non-study-related minor procedures within 7 days of treatment.
    • Prior therapy with KRASG12C (ON) inhibitor
    • Other exclusion criteria may apply.

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