Dose Escalation and Dose Expansion Study of RMC-6291 Monotherapy in Subjects With Advanced KRASG12C Mutant Solid Tumors

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Trial ID: NCT05462717

Purpose

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.

Official 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

Eligibility


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

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 inclusion/exclusion criteria may apply.

Intervention(s):

drug: RMC-6291

Recruiting

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Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Feriel Buchholz
650-721-4090

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