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

Phase 1

Active, not recruiting

• Conditions: Advanced KRASG12C Mutant Solid TumorsKRASG12C NSCLC; Advanced KRASG12C Mutant Solid Tumors; KRASG12C NSCLC with or without prior exposure to KRASG12C(OFF) inhibitor

• Registration Number: TCTR20230412004
• Lead Sponsor: Revolution Medicines, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-12
• Last Update Posted: 19 August 2024
• Study Completion: 2024-11-30

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 222

Inclusion Criteria

1. Subject must be equal or more than 18 years of age.
2. 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.
3. ECOG performance status 0 or 1
4. Prior treatment with a KRASG12C (OFF) inhibitor allowed
5. Adequate organ function

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adverse events [ Time Frame: up to 3 years ] 3 years Number of participants with adverse events,Dose Limiting Toxicities [ Time Frame: The first 21 days (i.e. Cycle 1) ] 21 days Number of participants with dose limiting toxicities

Secondary Outcome Measures

Name	Time	Method
Maximum Observed Blood Concentration of RMC-6291 [ Time Frame: 7 Cycles] 7 Cycles Cmax,Time to Reach Maximum Blood Concentration of RMC-6291 [ Time Frame: 7 Cycles] 7 Cycles Tmax,Area Under Blood Concentration Time Curve of RMC-6291 [ Time Frame: 7 Cycles ] 7 Cycles AUC,Elimination Half-Life of RMC-6291 [ Time Frame: 7 Cycles] 7 Cycles t1/2,Ratio of accumulation of RMC-6291 from a single dose to steady state with repeated dosing [ Time Frame: 7 Cycles ] 7 Cycles accumulation ratio,Overall Response Rate (ORR) [ Time Frame: 3 years ] 3 years Overall response rate per RECIST v1.1,Duration of Response (DOR) [ Time Frame: 3 years ] 3 Years Duration of response per RECIST v1.1,Disease Control Rate (DCR) [ Time Frame: 3 years ] 3 years Disease control rate per RECIST v1.1,Time to Response (TTR) [ Time Frame: 3 years ] 3 years Time to response per RECIST v1.1,Progression-Free Survival (PFS) [ Time Frame: 3 years ] 3 years Progression-free survival per RECIST v1.1