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

Summary

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

Interventions

• RMC-6236 · DRUG

  Oral tablet

• mFOLFOX6 regimen · DRUG

  IV infusion

• bevacizumab · DRUG

  IV infusion

• mFOLFIRINOX regimen · DRUG

  IV infusion

• cetuximab · DRUG

  IV infusion

• gemcitabine · DRUG

  IV infusion

• nab-paclitaxel · DRUG

  IV infusion

• RMC-9805 · DRUG

  Oral Tablet

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

Inclusion Criteria:

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)

Exclusion Criteria:

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.

Sites (32)

• Ironwood Cancer and Research Centers, Chandler, Arizona · RECRUITING
• Mayo Clinic Hospital, Phoenix, Arizona · RECRUITING
• HonorHealth Research Institute, Scottsdale, Arizona · RECRUITING
• UC San Diego Moores Cancer Center, La Jolla, California · RECRUITING
• Cedars-Sinai Cancer at Cedars-Sinai Medical Center, Los Angeles, California · RECRUITING
• UCLA Hematology/Oncology- Santa Monica, Los Angeles, California · RECRUITING
• University of Colorado Hospital-Anschutz Cancer Pavilion, Aurora, Colorado · RECRUITING
• Yale-New Haven Hospital-Yale Cancer Center, New Haven, Connecticut · RECRUITING
• Mayo Clinic Cancer Center, Jacksonville, Florida · RECRUITING
• Moffitt Cancer Center, Tampa, Florida · RECRUITING
• The University of Kansas Clinical Research Center, Westwood, Kansas · RECRUITING
• The Sidney Kimmel Comprehensive Cancer Center at John Hopkins, Baltimore, Maryland · RECRUITING
• Massachusetts General Hospital, Boston, Massachusetts · RECRUITING
• Dana Farber Cancer Institute, Boston, Massachusetts · RECRUITING
• Mayo Clinic, Rochester, Minnesota · RECRUITING
• Nebraska Cancer Specialists, Omaha, Nebraska · RECRUITING
• University of Nebraska Medical Center, Omaha, Nebraska · RECRUITING
• Atlantic Health System, Morristown, New Jersey · RECRUITING
• Northwell Health / RJ Zuckerberg Cancer Center, Lake Success, New York · RECRUITING
• Columbia University Medical Center, New York, New York · RECRUITING
• Memorial Sloan Kettering Cancer Center Main Campus, New York, New York · RECRUITING
• Duke University Medical Center, Durham, North Carolina · RECRUITING
• University of Cincinnati Medical Center, Cincinnati, Ohio · RECRUITING
• Stephenson Cancer Center, Oklahoma City, Oklahoma · RECRUITING
• Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania · RECRUITING
• SCRI Oncology Partners, Nashville, Tennessee · RECRUITING
• Baylor College of Medicine, Houston, Texas · RECRUITING
• The University of Texas MD Anderson Cancer Center, Houston, Texas · RECRUITING
• NEXT Oncology Dallas, Irving, Texas · RECRUITING
• Huntsman Cancer Institute, University of Utah, Salt Lake City, Utah · RECRUITING
• Virginia Cancer Specialists, Fairfax, Virginia · RECRUITING
• Fred Hutchinson Cancer Center, Seattle, Washington · RECRUITING