Revolution Medicines, Inc.
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
Colorectal Cancer
CRC
Pancreatic Ductal Adenocarcinoma
PDAC
Gastrointestinal Cancer
Metastatic Pancreatic Ductal Adenocarcinoma
RMC-6236
mFOLFOX6 regimen
bevacizumab
mFOLFIRINOX regimen
cetuximab
gemcitabine
nab-paclitaxel
RMC-9805
PHASE1
PHASE2
The platform study design allows combinations of RAS(ON) inhibitors with other anticancer agents to be evaluated in patients with RAS-mutated solid tumors with a focus on GI cancers. This is an open-label platform study to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of novel RAS(ON) inhibitors combined with Standard of Care (SOC) or with novel agents, and to define the Recommended Phase 2 Dose and Schedule (RP2DS). Enrollment of patients with RAS mutations will be specified in each subprotocol. Subprotocol A is an open-label, multicenter study of RMC-6236 in combination with 5-fluorouracil-based regimens in patients with treatment-naïve unresectable or metastatic colorectal cancer or treatment-naïve metastatic pancreatic ductal adenocarcinoma. Subprotocol B is an open-label, multicenter study of RMC-6236 in combination with cetuximab with or without mFOLFOX6 in patients with unresectable or metastatic colorectal cancer or patients with previously treated or treatment-naïve metastatic pancreatic ductal adenocarcinoma. Subprotocol C is an open-label, multicenter study of RMC-6236 in combination with gemcitabine and nab-paclitaxel in patients with treatment-naïve metastatic pancreatic ductal adenocarcinoma. Subprotocol D is an open-label, multicenter study of RMC-9805 with or without RMC-6236 in combination with 5-fluorouracil-based regimens in patients with RAS G12D-mutant unresectable or metastatic colorectal cancer or metastatic pancreatic ductal adenocarcinoma. Subprotocol E is an open-label, multicenter study of RMC-9805 with or without RMC-6236 in combination with cetuximab-based therapies with or without mFOLFOX6 in patients with RAS G12D-mutant unresectable or metastatic colorectal cancer or metastatic pancreatic ductal adenocarcinoma. Subprotocol F is an open-label, multicenter study of RMC-9805 with or without RMC-6236 in combination with gemcitabine and nab-paclitaxel in patients with RAS G12D-mutant metastatic pancreatic ductal adenocarcinoma. Each subprotocol consists of two parts: Part 1 - Dose Exploration and Part 2 - Dose Expansion.
| Study Type : | INTERVENTIONAL |
| Estimated Enrollment : | 1130 participants |
| Masking : | NONE |
| Primary Purpose : | TREATMENT |
| Official Title : | A Platform Study of RAS(ON) Inhibitors in Patients With Gastrointestinal Solid Tumors |
| Actual Study Start Date : | 2024-05-24 |
| Estimated Primary Completion Date : | 2027-05-15 |
| Estimated Study Completion Date : | 2027-07-15 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: | 18 Years |
| Sexes Eligible for Study: | ALL |
| Accepts Healthy Volunteers: |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
RECRUITING
Mayo Clinic Hospital
Phoenix, Arizona, United States, 85054
RECRUITING
HonorHealth Research Institute
Scottsdale, Arizona, United States, 85258
RECRUITING
UCLA Hematology/Oncology- Santa Monica
Los Angeles, California, United States, 90404
RECRUITING
University of Colorado Hospital-Anschutz Cancer Pavilion
Aurora, Colorado, United States, 88045
RECRUITING
Mayo Clinic Cancer Center
Jacksonville, Florida, United States, 32224
RECRUITING
Moffitt Cancer Center
Tampa, Florida, United States, 33612
RECRUITING
The Sidney Kimmel Comprehensive Cancer Center at John Hopkins
Baltimore, Maryland, United States, 21287
RECRUITING
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
RECRUITING
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
RECRUITING
Mayo Clinic
Rochester, Minnesota, United States, 55905
RECRUITING
Columbia University Medical Center
New York, New York, United States, 10032
RECRUITING
Memorial Sloan Kettering Cancer Center Main Campus
New York, New York, United States, 10065
RECRUITING
Duke University Medical Center
Durham, North Carolina, United States, 27710
RECRUITING
University of Cincinnati Medical Center
Cincinnati, Ohio, United States, 45267
RECRUITING
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
RECRUITING
SCRI Oncology Partners
Nashville, Tennessee, United States, 37203
RECRUITING
Baylor College of Medicine
Houston, Texas, United States, 77030
RECRUITING
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
RECRUITING
NEXT Oncology Dallas
Irving, Texas, United States, 75039
RECRUITING
Huntsman Cancer Institute, University of Utah
Salt Lake City, Utah, United States, 84112
RECRUITING
Virginia Cancer Specialists
Fairfax, Virginia, United States, 22314
RECRUITING
Fred Hutchinson Cancer Center
Seattle, Washington, United States, 98109