Lung Cancer Clinical Trial

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

Summary

Evaluate the safety and tolerability of RMC-6236 in adults with KRAS p.G12 mutant advanced solid tumors, KRAS p.G12C excluded.

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Full Description

This is a Phase 1/1b, 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).

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Eligibility Criteria

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.
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.

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

474

Study ID:

NCT05379985

Recruitment Status:

Recruiting

Sponsor:

Revolution Medicines, Inc.

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There are 15 Locations for this study

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UC Irvine/Chao Family Comprehensive Cancer Center
Orange California, 92868, United States
UCLA
Santa Monica California, 90404, 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
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

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

474

Study ID:

NCT05379985

Recruitment Status:

Recruiting

Sponsor:


Revolution Medicines, Inc.

How clear is this clinincal trial information?

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