Study of RAS(ON) Inhibitors in Patients With Gastrointestinal Solid Tumors
A Platform Study of RAS(ON) Inhibitors in Patients With Gastrointestinal Solid Tumors
Revolution Medicines, Inc.
1,130 participants
May 24, 2024
INTERVENTIONAL
Conditions
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
Eligibility
Inclusion Criteria6
- 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 Criteria4
- 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
Interventions
Oral tablet
IV infusion
IV infusion
IV infusion
IV infusion
IV infusion
IV infusion
Oral Tablet
Locations(32)
View Full Details on ClinicalTrials.gov
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NCT06445062