A Multicenter Open-Label 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
NCT #
NCT05379985
Condition(s)
Colorectal, Non-Small Cell Lung, Solid Tumors Pancreatic
Molecular Target(s)
KRAS G12
Drug Classification(s)
Small Molecule
Agents(s)
RMC-6236
Phase(s)
I
Mechanism of Action
RMC-6236 inhibits the RAS(ON) state of multiple RAS variants both mutant and wild-type proteins.
Purpose
- How much of the study can be given with an acceptable level of side effects
- The effects of the study (good and bad)
- How much of the study is absorbed into the blood and how fast it is removed
- If research tests can be used in the future to predict who will benefit from the study drug
- 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
- 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
Subject with tumors harboring KRASG12C mutations are not eligible Subjects who have had prior therapy with any direct RAS inhibitor.
Location
MCD
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