NCT07397338 Study of RAS(ON) Inhibitors in Combination With Ivonescimab in Patients With Solid Tumors
| NCT ID | NCT07397338 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Revolution Medicines, Inc. |
| Condition | Advanced Solid Tumors |
| Study Type | INTERVENTIONAL |
| Enrollment | 370 participants |
| Start Date | 2026-01-30 |
| Primary Completion | 2029-05 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
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 370 participants in total. It began in 2026-01-30 with a primary completion date of 2029-05.
⚠ 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 study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of RAS(ON) inhibitors in combination with ivonescimab in adults with advanced or metastatic solid tumors with a RAS mutation.
Eligibility Criteria
Inclusion Criteria: * At least 18 years old and has provided informed consent. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Histologically confirmed, locally advanced or metastatic solid tumor malignancy with documented RAS mutation in KRAS, HRAS, or NRAS. * Received and progressed or been intolerant to prior standard therapy (Part 1 Dose Exploration). * Non-squamous NSCLC without a treatable driver mutation in other oncogenes that has not received prior systemic treatment (Arms A \& B for Part 2 Dose Expansion). * Solid tumor or CRC previously treated with no more than 2 prior lines of therapy for advanced disease and progressed or been intolerant to prior standard therapies (Arm C for Part 2 Dose Expansion). * Measurable disease per RECIST v1.1 * Adequate organ function (bone marrow, liver, kidney, coagulation, endocrine). * Able to take oral medications. Exclusion Criteria: * Head and neck squamous cell carcinoma. * Any conditions that may affect the ability to take or absorb study drug. * Major surgery within 4 weeks prior to receiving study drug(s). * Patient is unable or unwilling to comply with protocol-required study visits or procedures. * Other inclusion/exclusion criteria may apply.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07397338 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Advanced Solid Tumors. 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 NCT07397338 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 NCT07397338 currently recruiting?
Yes, NCT07397338 is actively recruiting participants. Contact the research team at medinfo@revmed.com for enrollment information.
Where is the NCT07397338 trial being conducted?
This trial is being conducted at Norwich, United States, Nashville, United States, Houston, United States, Irving, United States and 2 additional locations.
Who is sponsoring the NCT07397338 clinical trial?
NCT07397338 is sponsored by Revolution Medicines, Inc.. The trial plans to enroll 370 participants.