Study of RAS(ON) Inhibitors in Patients With Gastrointestinal Solid Tumors
Recruiting · NCT06445062 · Interventional (participants receive a specific treatment) · Lead sponsor: Revolution Medicines, Inc.
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1, Phase 2
Study type
Interventional (participants receive a specific treatment)
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
- ther inclusion/exclusion criteria may apply.
Where it is running
60 locations listed across 21 US states.
- Ironwood Cancer and Research Centers - Chandler, Arizona, United States
- Ironwood Cancer and Research Centers - Chandler, Arizona, United States
- Mayo Clinic Hospital - Phoenix, Arizona, United States
- Mayo Clinic Hospital - Phoenix, Arizona, United States
- HonorHealth Research Institute - Scottsdale, Arizona, United States
- HonorHealth Research Institute - Scottsdale, Arizona, United States
- UC San Diego Moores Cancer Center - La Jolla, California, United States
- UC San Diego Moores Cancer Center - La Jolla, California, United States
- Cedars-Sinai Cancer at Cedars-Sinai Medical Center - Los Angeles, California, United States
- UCLA Hematology/Oncology- Santa Monica - Los Angeles, California, United States
- Cedars-Sinai Cancer at Cedars-Sinai Medical Center - Los Angeles, California, United States
- UCLA Hematology/Oncology- Santa Monica - Los Angeles, California, United States
- University of Colorado Hospital-Anschutz Cancer Pavilion - Aurora, Colorado, United States
- University of Colorado Hospital-Anschutz Cancer Pavilion - Aurora, Colorado, United States
- Yale-New Haven Hospital-Yale Cancer Center - New Haven, Connecticut, United States
- Yale-New Haven Hospital-Yale Cancer Center - New Haven, Connecticut, United States
- Mayo Clinic Cancer Center - Jacksonville, Florida, United States
- Mayo Clinic Cancer Center - Jacksonville, Florida, United States
- Moffitt Cancer Center - Tampa, Florida, United States
- Moffitt Cancer Center - Tampa, Florida, United States
- The University of Kansas Clinical Research Center - Westwood, Kansas, United States
- The University of Kansas Clinical Research Center - Westwood, Kansas, United States
- The Sidney Kimmel Comprehensive Cancer Center at John Hopkins - Baltimore, Maryland, United States
- The Sidney Kimmel Comprehensive Cancer Center at John Hopkins - Baltimore, Maryland, United States
- Massachusetts General Hospital - Boston, Massachusetts, United States
- Dana Farber Cancer Institute - Boston, Massachusetts, United States
- Massachusetts General Hospital - Boston, Massachusetts, United States
- Dana Farber Cancer Institute - Boston, Massachusetts, United States
- Mayo Clinic - Rochester, Minnesota, United States
- Mayo Clinic - Rochester, Minnesota, United States
- Nebraska Cancer Specialists - Omaha, Nebraska, United States
- University of Nebraska Medical Center - Omaha, Nebraska, United States
- Nebraska Cancer Specialists - Omaha, Nebraska, United States
- University of Nebraska Medical Center - Omaha, Nebraska, United States
- Atlantic Health System - Morristown, New Jersey, United States
- Atlantic Health System - Morristown, New Jersey, United States
- Northwell Health / RJ Zuckerberg Cancer Center - Lake Success, New York, United States
- Northwell Health / RJ Zuckerberg Cancer Center - Lake Success, New York, United States
- Columbia University Medical Center - New York, New York, United States
- Memorial Sloan Kettering Cancer Center Main Campus - New York, New York, United States
- Columbia University Medical Center - New York, New York, United States
- Memorial Sloan Kettering Cancer Center Main Campus - New York, New York, United States
- Duke University Medical Center - Durham, North Carolina, United States
- Duke University Medical Center - Durham, North Carolina, United States
- University of Cincinnati Medical Center - Cincinnati, Ohio, United States
- University of Cincinnati Medical Center - Cincinnati, Ohio, United States
- Stephenson Cancer Center - Oklahoma City, Oklahoma, United States
- Stephenson Cancer Center - Oklahoma City, Oklahoma, United States
- Hospital of the University of Pennsylvania - Philadelphia, Pennsylvania, United States
- Hospital of the University of Pennsylvania - Philadelphia, Pennsylvania, United States
- SCRI Oncology Partners - Nashville, Tennessee, United States
- SCRI Oncology Partners - Nashville, Tennessee, United States
- Baylor College of Medicine - Houston, Texas, United States
- The University of Texas MD Anderson Cancer Center - Houston, Texas, United States
- Baylor College of Medicine - Houston, Texas, United States
- The University of Texas MD Anderson Cancer Center - Houston, Texas, United States
- NEXT Oncology Dallas - Irving, Texas, United States
- NEXT Oncology Dallas - Irving, Texas, United States
- Huntsman Cancer Institute, University of Utah - Salt Lake City, Utah, United States
- Huntsman Cancer Institute, University of Utah - Salt Lake City, Utah, United States
Showing 60 of 64 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →