Status:
RECRUITING
Study of RMC-6236 in Patients With Advanced Solid Tumors Harboring Specific Mutations in RAS
Lead Sponsor:
Revolution Medicines, Inc.
Conditions:
Non-small Cell Lung Cancer (NSCLC)
Colorectal Cancer (CRC)
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 sol...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 31 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 26 2027
Estimated Enrollment :
754 Patients enrolled
Trial Details
Trial ID
NCT05379985
Start Date
May 31 2022
End Date
July 26 2027
Last Update
November 12 2025
Active Locations (16)
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1
UC Irvine/Chao Family Comprehensive Cancer Center
Orange, California, United States, 92868
2
UCLA
Santa Monica, California, United States, 90404
3
Moffitt Cancer Center
Tampa, Florida, United States, 33612
4
Johns Hopkins University
Baltimore, Maryland, United States, 21287