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Clinical Trial 21850

Cancer Type: Thoracic
Study Type: Treatment
NCT#: NCT05462717

Phase: Phase I
Principal Investigator: Pellini, Bruna

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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.



Hormonal Therapy


RMC-6291 ()

Inclusion Criteria

  • Subject must be >18 years of age.
  • Subject 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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