Study of RAS(ON) Inhibitors in Patients With Gastrointestinal Solid Tumors

Recruiting now · Phase 1/Phase 2

Conditions studied: Colorectal Cancer, CRC, Pancreatic Ductal Adenocarcinoma, PDAC, Gastrointestinal Cancer, Metastatic Pancreatic Ductal Adenocarcinoma

In brief

The purpose of this platform study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of novel RAS(ON) inhibitors combined with Standard(s) of Care (SOC) or with novel agents. The current subprotocols include the following: Subprotocol A: RMC-6236 + 5-fluorouracil-based regimens Subprotocol B: RMC-6236 + cetuximab with or without mFOLFOX6 Subprotocol C: RMC-6236 + gemcitabine + nab-paclitaxel Subprotocol D: RMC-9805 with or without RMC-6236 + 5-fluorouracil-based regimens Subprotocol E: RMC-9805 with or without RMC-6236 + cetuximab with or without mFOLFOX6 Subprotocol F: RMC-9805 with or without RMC-6236 + gemcitabine + nab-paclitaxel

Key facts

Study ID

NCT06445062

Run by

Revolution Medicines, Inc.

People needed

1130

Starts

2024-05-24

Expected to finish

2027-07-15

Last updated by the study team

2026-07-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• All Patients (unless otherwise noted):
• ≥ 18 years of age
• ECOG PS is 0 to 1
• Adequate organ function as outlined by the study
• Pathologically or cytologically documented pancreatic carcinoma or poorly differentiated pancreatic carcinoma with metastatic disease or RAS-mutated, histologically or cytologically confirmed colorectal adenocarcinoma with documented unresectable or metastatic disease (Subprotocol A, B, and C)
• Presence of RAS G12D mutation (Subprotocol D, E, F)

You may not qualify if…

• All Patients:
• Primary central nervous system (CNS) tumors
• Impaired gastrointestinal (GI) function that may significantly alter the absorption of RMC drugs
• Major surgery within 28 days of first dose
• Other inclusion/exclusion criteria may apply.

Where it is running

• Ironwood Cancer and Research Centers — Chandler, Arizona, United States (enrolling)
• Mayo Clinic Hospital — Phoenix, Arizona, United States (enrolling)
• HonorHealth Research Institute — Scottsdale, Arizona, United States (enrolling)
• UC San Diego Moores Cancer Center — La Jolla, California, United States (enrolling)
• Cedars-Sinai Cancer at Cedars-Sinai Medical Center — Los Angeles, California, United States (enrolling)
• UCLA Hematology/Oncology- Santa Monica — Los Angeles, California, United States (enrolling)
• University of Colorado Hospital-Anschutz Cancer Pavilion — Aurora, Colorado, United States (enrolling)
• Yale-New Haven Hospital-Yale Cancer Center — New Haven, Connecticut, United States (enrolling)
• Mayo Clinic Cancer Center — Jacksonville, Florida, United States (enrolling)
• Moffitt Cancer Center — Tampa, Florida, United States (enrolling)
• The University of Kansas Clinical Research Center — Westwood, Kansas, United States (enrolling)
• The Sidney Kimmel Comprehensive Cancer Center at John Hopkins — Baltimore, Maryland, United States (enrolling)
• Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
• Dana Farber Cancer Institute — Boston, Massachusetts, United States (enrolling)
• Mayo Clinic — Rochester, Minnesota, United States (enrolling)
• Nebraska Cancer Specialists — Omaha, Nebraska, United States (enrolling)
• University of Nebraska Medical Center — Omaha, Nebraska, United States (enrolling)
• Atlantic Health System — Morristown, New Jersey, United States (enrolling)
• Northwell Health / RJ Zuckerberg Cancer Center — Lake Success, New York, United States (enrolling)
• Columbia University Medical Center — New York, New York, United States (enrolling)
• Memorial Sloan Kettering Cancer Center Main Campus — New York, New York, United States (enrolling)
• Duke University Medical Center — Durham, North Carolina, United States (enrolling)
• University of Cincinnati Medical Center — Cincinnati, Ohio, United States (enrolling)
• Stephenson Cancer Center — Oklahoma City, Oklahoma, United States (enrolling)
• Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States (enrolling)

Full record on ClinicalTrials.gov

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