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

• Status: Not yet recruiting
• Trial end date: 2025-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Revolution Medicines, Inc.

Criteria

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.