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

Study Status: Recruiting

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 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).

Sex: ALL
Minimum Age: 18 Years

Researchers look for people who fit a certain description, called eligibility criteria. Below are the inclusion and exclusion criteria for study participants:

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. 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

Exlusion 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.

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Non-small Cell Lung Cancer (NSCLC), Colorectal Cancer (CRC), Pancreatic Ductal Adenocarcinoma (PDAC), Advanced Solid Tumors

Intervention/Treatment

DRUG : RMC-6236

Sponsor

Revolution Medicines, Inc.

Principal Investigator(s)

Revolution Medicines, Inc., STUDY_DIRECTOR, Revolution Medicines, Inc.

Phase

PHASE1
PHASE2