Study Of RMC-6291 In Combination With RMC-6236 In Participants With Advanced KRAS G12C Mutant Solid Tumors

Study Overview

Study of RMC-6291 in Combination with RMC-6236 in Participants with Advanced KRAS G12C Mutant Solid Tumors

This study is to evaluate the safety, tolerability, and PK profiles of RMC-6291 and RMC-6236 in adults with KRAS G12C-mutated solid tumors.

This is an open-label, multicenter, Phase 1b study of RMC-6291 in combination with RMC-6236 in participants with advanced KRAS G12C-mutated solid tumors, to identify the maximum tolerated dose (MTD) and/or recommended Phase 2 dose and schedule (RP2DS) and provide a preliminary assessment of the antitumor activity of RMC-6291 in participants with KRASG12C tumors. The study consists of two parts: Part 1 - Dose-Escalation and Part 2 Dose-Expansion.

Non-Small Cell Lung Cancer (NSCLC)
Colorectal Cancer
Pancreatic Ductal Adenocarcinoma

DRUG: Assigned interventions

RMC-6291-101

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2023-11-07	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-03-24
First Submitted that Met QC Criteria 2023-11-07	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-03-27
First Posted (ACTUAL) 2023-11-13	Results First Posted N/A	Last Verified 2025-03

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: RMC-6291 and RMC-6236 Dose escalation and Dose expansion	DRUG: Assigned interventions Drug: RMC-6291 and RMC-6236 Oral tablets

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: RMC-6291 and RMC-6236

Dose escalation and Dose expansion

DRUG: Assigned interventions

Drug: RMC-6291 and RMC-6236 Oral tablets

Primary Outcome Measures	Measure Description	Time Frame
Adverse events	Incidence and severity of treatment-emergent Adverse Events (AEs) and serious AEs and clinically significant changes in laboratory values, ECGs and vitals signs	up to 3 years
Dose Limiting Toxicities	Number of participants with dose limiting toxicities	21 days

Secondary Outcome Measures	Measure Description	Time Frame
Maximum Observed Blood Concentration of RMC-6291 and RMC-6236	Cmax	up to 21 weeks
Time to Reach Maximum Blood Concentration of RMC-6291 and RMC-6236	Tmax	up to 21 weeks
Area Under Blood Concentration Time Curve of RMC-6291 and RMC-6236	AUC	up to 21 weeks
Elimination Half-Life of RMC-6291 and RMC-6236	t1/2	up to 21 weeks
Ratio of accumulation of RMC-6291 and RMC-6236 from a single dose to steady state with repeated dosing	accumulation ratio	up to 21 weeks
Overall Response Rate (ORR)	Overall response rate RECIST v1.1	up to 3 years
Duration of Response (DOR)	Duration of response per RECIST v1.1	up to 3 years
Disease Control Rate	Disease Control rate per RECIST v1.1	up to 3 years
Time to Response (TTR)	Time to response per RECIST v1.1	up to 3 years
Progression-Free Survival (PFS)	Progression-free survival per RECIST v1.1	up to 3 years

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Revolution Medicines, Inc.

Phone Number: 1-844-2-REVMED

Email: medinfo@revmed.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

18 years of age
Histology: pathologically documented, KRAS G12C-mutated, advanced or metastatic solid tumors not amendable to curative therapy

ECOG performance status 0 or 1
Adequate organ function

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

STUDY_DIRECTOR: Revolution Medicines, Inc., Revolution Medicines, Inc.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

Patients

Caregivers

Clinical Trial Record