A Platform Study of RAS(ON) Inhibitors in Patients With Gastrointestinal Solid Tumors
Revolution Medicines, Inc.
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
Description
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…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 gas…
Interventions
- DrugRMC-6236
Oral tablet
- DrugmFOLFOX6 regimen
IV infusion
- Drugbevacizumab
IV infusion
- DrugmFOLFIRINOX regimen
IV infusion
- Drugcetuximab
IV infusion
- Druggemcitabine
IV infusion
- Drugnab-paclitaxel
IV infusion
- Drug
Locations (32)
- Ironwood Cancer and Research CentersChandler, Arizona
- Mayo Clinic HospitalPhoenix, Arizona
- HonorHealth Research InstituteScottsdale, Arizona
- UC San Diego Moores Cancer CenterLa Jolla, California
- Cedars-Sinai Cancer at Cedars-Sinai Medical CenterLos Angeles, California
- UCLA Hematology/Oncology- Santa MonicaLos Angeles, California