Lung Cancer Clinical Trial

Evaluation of RMC-6236 in Subjects With Advanced Solid Tumors Harboring Specific Mutations in KRAS

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, open-label, multicenter study to evaluate the safety, tolerability, pharmacokinetics (PK), and clinical activity of escalating doses of RMC-6236 in adult subjects with KRAS p.G12 mutant advanced solid tumors, p.G12C excluded, and to determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose [RP2D] within investigated subject population groups. RMC-6236 is a potent, orally bioavailable RASMUTLI(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 KRAS p.G12A, KRAS p.G12D, KRAS p.G12R, KRAS p.G12S, or KRAS p.G12V mutations 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 to 1
Adequate organ function

Exclusion Criteria:

Tumor harboring the KRAS p.G12C mutation
Primary central nervous system (CNS) tumors
Known or suspected leptomeningeal or brain metastases or spinal cord compression
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

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

141

Study ID:

NCT05379985

Recruitment Status:

Recruiting

Sponsor:

Revolution Medicines, Inc.

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There are 10 Locations for this study

See Locations Near You

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
Christ Hospital Cancer Center
Cincinnati Ohio, 45219, United States
Sarah Cannon Research Institute
Nashville Tennessee, 37203, 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:

141

Study ID:

NCT05379985

Recruitment Status:

Recruiting

Sponsor:


Revolution Medicines, Inc.

How clear is this clinincal trial information?

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