NCT06445062 Study of RAS(ON) Inhibitors in Patients With Gastrointestinal Solid Tumors
| NCT ID | NCT06445062 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Revolution Medicines, Inc. |
| Condition | Colorectal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,130 participants |
| Start Date | 2024-05-24 |
| Primary Completion | 2027-05-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 1,130 participants in total. It began in 2024-05-24 with a primary completion date of 2027-05-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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 gastrointestinal (GI) function that may significantly alter the absorption of RMC drugs * Major surgery within 28 days of first dose Other inclusion/exclusion criteria may apply.
Contact & Investigator
Study Director
STUDY DIRECTOR
Revolution Medicines
Frequently Asked Questions
Who can join the NCT06445062 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Colorectal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06445062 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06445062 currently recruiting?
Yes, NCT06445062 is actively recruiting participants. Contact the research team at medinfo@revmed.com for enrollment information.
Where is the NCT06445062 trial being conducted?
This trial is being conducted at Chandler, United States, Phoenix, United States, Scottsdale, United States, La Jolla, United States and 11 additional locations.
Who is sponsoring the NCT06445062 clinical trial?
NCT06445062 is sponsored by Revolution Medicines, Inc.. The principal investigator is Study Director at Revolution Medicines. The trial plans to enroll 1,130 participants.
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