Study of RAS(ON) Inhibitors in Patients With Gastrointestinal Solid Tumors

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorRevolution Medicines, Inc.

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

1,130 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Sponsors and collaborators