Non-small Cell Lung Cancer (NSCLC)Colorectal Cancer (CRC)Pancreatic Ductal Adenocarcinoma (PDAC)Advanced Solid Tumors
Investigational drug(s) / intervention(s)
RMC-6236
RMC-6236: Oral Tablets
Study summary
Evaluate the safety and tolerability of RMC-6236 in adults with specific RAS mutant advanced solid tumors.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
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.
Primary outcome measure(s)
Incidence and severity of treatment-emergent Adverse Events (AEs) and serious AEs, including incidence and severity of findings in laboratory values and vital signs — up to 2.5 years
Number of Participants with Dose-Limiting Toxicity (DLT) — 21 days
Trial sites (21)
Facility
City
Region
Status
UC Irvine/Chao Family Comprehensive Cancer Center
Orange
California
Recruiting
UCLA
Santa Monica
California
Recruiting
Moffitt Cancer Center
Tampa
Florida
Recruiting
Piedmont Healthcare
Atlanta
Georgia
Recruiting
Mary Bird Perkins Cancer Center
Baton Rouge
Louisiana
Recruiting
Johns Hopkins University
Baltimore
Maryland
Recruiting
Dana Farber Cancer Institute
Boston
Massachusetts
Recruiting
Perlmutter Cancer Center at NYU Langone Health
New York
New York
Recruiting
Memorial Sloan-Kettering Cancer Center
New York
New York
Recruiting
Columbia University
New York
New York
Recruiting
Christ Hospital Cancer Center
Cincinnati
Ohio
Recruiting
Taylor Cancer Research Center
Maumee
Ohio
Recruiting
Tennessee Oncology
Chattanooga
Tennessee
Recruiting
Sarah Cannon Research Institute
Nashville
Tennessee
Recruiting
University of Texas at Austin
Austin
Texas
Recruiting
Mary Crowley Cancer Research
Dallas
Texas
Recruiting
The University of Texas MD Anderson Cancer Center
Houston
Texas
Recruiting
Next Oncology
San Antonio
Texas
Recruiting
Huntsman Cancer Institute
Salt Lake City
Utah
Recruiting
Next Oncology Virginia
Fairfax
Virginia
Recruiting
Virginia Mason Medical Center
Seattle
Washington
Recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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