RecruitingPhase 1Phase 2NCT05379985

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

A Multicenter Open-Label Study of RMC-6236 in Patients With Advanced Solid Tumors Harboring Specific Mutations in RAS


Sponsor

Revolution Medicines, Inc.

Enrollment

754 participants

Start Date

May 31, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • 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 Criteria4

  • 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

Interventions

DRUGRMC-6236

Oral Tablets


Locations(16)

UC Irvine/Chao Family Comprehensive Cancer Center

Orange, California, United States

UCLA

Santa Monica, California, United States

Moffitt Cancer Center

Tampa, Florida, United States

Johns Hopkins University

Baltimore, Maryland, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Perlmutter Cancer Center at NYU Langone Health

New York, New York, United States

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Columbia University

New York, New York, United States

Christ Hospital Cancer Center

Cincinnati, Ohio, United States

Sarah Cannon Research Institute

Nashville, Tennessee, United States

University of Texas at Austin

Austin, Texas, United States

Mary Crowley Cancer Research

Dallas, Texas, United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Next Oncology

San Antonio, Texas, United States

Huntsman Cancer Institute

Salt Lake City, Utah, United States

Next Oncology Virginia

Fairfax, Virginia, United States

View Full Details on ClinicalTrials.gov

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NCT05379985


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