Study of RAS(ON) Inhibitors in Patients With Gastrointestinal Solid Tumors
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
Inclusion Criteria
- 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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06445062.
Locations matching your search criteria
United States
Arizona
Scottsdale
California
La Jolla
Los Angeles
Colorado
Aurora
Lone Tree
Connecticut
Derby
Fairfield
Greenwich
Guilford
New Haven
North Haven
Stamford
Torrington
Trumbull
Waterbury
Waterford
Florida
Jacksonville
Tampa
Kansas
Kansas City
Maryland
Baltimore
Massachusetts
Boston
Minnesota
Rochester
Nebraska
Omaha
New York
New York
North Carolina
Durham
Oklahoma
Oklahoma City
Pennsylvania
Philadelphia
Rhode Island
Westerly
Texas
Houston
Utah
Salt Lake City
Washington
Seattle
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.
Trial PhasePhase I/II
Trial Typetreatment
Lead OrganizationRevolution Medicines, Inc.
- Primary IDRMC-GI-102
- Secondary IDsNCI-2024-05164
- ClinicalTrials.gov IDNCT06445062