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NCT06040541PHASE1Recruiting

Study of RMC-9805 in Participants With KRAS G12D-Mutant Solid Tumors

Revolution Medicines, Inc.

Start Date

9/7/2023

Completion Date

4/30/2027

Summary

This study is to evaluate the safety and tolerability of RMC-9805 as monotherapy and in combination with RMC-6236 in adults with KRAS G12D-mutant solid tumors.

Detailed Description

This is an open-label, multicenter, Phase 1/1b study of RMC-9805, a selective and orally bioavailable KRAS G12D(ON) inhibitor, in subjects with KRASG12D-mutant solid tumors to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary clinical activity. The study consists of two arms: RMC-9805 monotherapy arm and RMC-9805 plus RMC-6236 combination arm. Both arms consist of two parts: Part 1- dose exploration and Part 2- dose expansion.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Pathologically documented, locally advanced or metastatic solid tumor with a KRAS G12D-mutation * Received and progressed or been intolerant to prior standard therapy (including targeted therapy) appropriate for tumor type and stage * ECOG performance status 0 or 1 * Adequate organ function Exclusion Criteria: * Primary central nervous system (CNS) tumors * Known or suspected leptomeningeal or active brain metastases or spinal cord compression * Known or suspected impairment of gastrointestinal function that may prohibit ability to swallow or absorb an oral medication * Participant was previously treated with an investigational KRAS G12D inhibitor, pan- or multi-RAS inhibitor, or had prior therapy with any direct RAS-targeted therapy (eg, degraders and inhibitors) Other inclusion/exclusion criteria may apply.

Interventions

DRUG

RMC-9805

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

University of California, Davis Comprehensive Cancer Center

Sacramento, California 95817

United States

Smilow Cancer Hospital (Yale University)

New Haven, Connecticut 06511

United States

Florida Cancer Specialists

Sarasota, Florida 34232

United States

Lee Moffitt Cancer Center

Tampa, Florida 33612

United States

Johns Hopkins University

Baltimore, Maryland 21287

United States

Massachusetts General Hospital

Boston, Massachusetts 02114

United States

Dana-Farber Cancer Institute

Boston, Massachusetts 02215

United States

NYU Langone

New York, New York 10016

United States

Memorial Sloan Kettering Cancer Center

New York, New York 10065

United States

Duke Cancer Center

Durham, North Carolina 27710

United States

Carolina BioOncology Institute

Huntersville, North Carolina 28078

United States

The Christ Hospital

Cincinnati, Ohio 45219

United States

Sarah Cannon Research Institute

Nashville, Tennessee 37203

United States

Sarah Cannon Research Institute at Mary Crowley

Dallas, Texas 75230

United States

University of Texas, MD Anderson Cancer Center

Houston, Texas 77030

United States

START

San Antonio, Texas 78229

United States

NEXT Oncology Virginia

Fairfax, Virginia 22031

United States