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

Conditions

• CRC
• Colorectal Cancer
• Gastrointestinal Cancer
• Metastatic Pancreatic Ductal Adenocarcinoma
• PDAC
• Pancreatic Ductal Adenocarcinoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• RMC-6236 — DRUG
  Oral tablet
• mFOLFOX6 regimen — DRUG
  IV infusion
• bevacizumab — DRUG
  IV infusion
• mFOLFIRINOX regimen — DRUG
  IV infusion
• cetuximab — DRUG
  IV infusion
• gemcitabine — DRUG
  IV infusion
• nab-paclitaxel — DRUG
  IV infusion
• RMC-9805 — DRUG
  Oral Tablet

Study Details

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

Key Dates

Start date

May 24, 2024

Status verified

Dec 2025

Primary completion

May 15, 2027

Completion

Jul 15, 2027

Study Design

Enrollment

1,130 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Subprotocol A: RAS-mutated unresectable or metastatic CRC or metastatic PDAC
  RMC-6236 (QD) and Bevacizumab with 5-fluorouracil-based regimens
• Experimental: Subprotocol B: RAS-mutated unresectable or metastatic CRC or metastatic PDAC
  RMC-6236 (QD) and Cetuximab with or without mFOLFOX6
• Experimental: Subprotocol C: metastatic PDAC
  RMC-6236 (QD) and Gemcitabine with Nab-paclitaxel
• Experimental: Subprotocol D: RAS G12D-mutated unresectable or metastatic CRC or metastatic PDAC
  RMC-9805 (QD or BID) with or without RMC-6236 (QD), and Bevacizumab with 5-fluorouracil- based regimens
• Experimental: Subprotocol E: RAS G12D-mutated unresectable or metastatic CRC or metastatic PDAC
  RMC-9805 (QD or BID) with or without RMC-6236 (QD), and Cetuximab with or without mFOLFOX6
• Experimental: Subprotocol F: RAS G12D-mutated metastatic PDAC
  RMC-9805 (QD or BID) with or without RMC-6236 (QD), and Gemcitabine with Nab-paclitaxel

Primary Outcome Measure

Adverse events [ Time Frame: Up to 3 years ]

Central Contacts

• Revolution Medicines
  1-844-2-REVMED
  [email protected]

Locations (32)

Find similar trials in Chandler, AZ

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