About this trial
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 criteria
Qualifiers
≥ 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)
Disqualifiers
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
Trial design
Treatments tested in this trial
- RMC-6236
- mFOLFOX6 regimen
- bevacizumab
- mFOLFIRINOX regimen
- cetuximab
- gemcitabine
- nab-paclitaxel
- RMC-9805
Treatment groups
6
Treatment groupsSee each treatment group below.