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NCT05379985PHASE1, PHASE2Recruiting

Study of RMC-6236 in Patients With Advanced Solid Tumors Harboring Specific Mutations in RAS

Revolution Medicines, Inc.

Start Date

5/31/2022

Completion Date

7/26/2027

Summary

Evaluate the safety and tolerability of RMC-6236 in adults with specific RAS mutant advanced solid tumors.

Detailed Description

This is a Phase 1/2, multicenter open-label study to evaluate the safety, tolerability, pharmacokinetics (PK), and clinical activity of escalating doses of RMC-6236 in adult patients with advanced solid tumors harboring specific RAS mutations, and to determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose \[RP2D\] within investigated patient population groups. RMC-6236 is a potent, orally bioavailable RAS-MULTI(ON) inhibitor, selective for the active RAS(ON) form of both wild type and mutant variants of the canonical RAS isoforms (HRAS, NRAS, and KRAS).

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Histologically confirmed advanced solid tumor with specific KRAS G12 mutations (dose escalation) or RAS mutations (dose optimization/expansion) identified through deoxyribonucleic acid (DNA) sequencing. PDAC with wild-type RAS (expansion). * Treatment naive or have received prior standard therapy appropriate for tumor type and stage * Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Adequate organ function Exclusion Criteria: * Primary central nervous system (CNS) tumors * Active, untreated brain metastases * Known or suspected impairment of gastrointestinal function that may prohibit ability to swallow or absorb an oral medication * History of any other unstable or clinically significant concurrent medical condition that would, in the opinion of the investigator, jeopardize the safety of a participant, impact their expected survival through the end of the study participation, and/or impact their ability to comply with the protocol prior/concomitant therapy Other inclusion/exclusion criteria may apply.

Interventions

DRUG

RMC-6236

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Conditions

Non-small Cell Lung Cancer (NSCLC)Colorectal Cancer (CRC)Pancreatic Ductal Adenocarcinoma (PDAC)Advanced Solid Tumors

Locations

UC Irvine/Chao Family Comprehensive Cancer Center

Orange, California 92868

United States

UCLA

Santa Monica, California 90404

United States

Moffitt Cancer Center

Tampa, Florida 33612

United States

Piedmont Healthcare

Atlanta, Georgia 30318

United States

Mary Bird Perkins Cancer Center

Baton Rouge, Louisiana 70809

United States

Johns Hopkins University

Baltimore, Maryland 21287

United States

Dana Farber Cancer Institute

Boston, Massachusetts 02215

United States

Perlmutter Cancer Center at NYU Langone Health

New York, New York 10016

United States

Memorial Sloan-Kettering Cancer Center

New York, New York 10021

United States

Columbia University

New York, New York 10032

United States

Christ Hospital Cancer Center

Cincinnati, Ohio 45219

United States

Taylor Cancer Research Center

Maumee, Ohio 43537

United States

Tennessee Oncology

Chattanooga, Tennessee 37404

United States

Sarah Cannon Research Institute

Nashville, Tennessee 37203

United States

University of Texas at Austin

Austin, Texas 78712

United States

Mary Crowley Cancer Research

Dallas, Texas 75230

United States

The University of Texas MD Anderson Cancer Center

Houston, Texas 77030

United States

Next Oncology

San Antonio, Texas 78229

United States

Huntsman Cancer Institute

Salt Lake City, Utah 84112

United States

Next Oncology Virginia

Fairfax, Virginia 22031

United States

Virginia Mason Medical Center

Seattle, Washington 98101

United States