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

Recruiting now · Phase 1/Phase 2

Conditions studied: Advanced Solid Tumors, Metastatic Solid Tumors, Non-small Cell Lung Cancer (NSCLC), NSCLC, Colorectal Cancer (CRC), CRC

In brief

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.

Key facts

Study ID

NCT07397338

Run by

Revolution Medicines, Inc.

People needed

370

Starts

2026-01-30

Expected to finish

2029-05-01

Last updated by the study team

2026-08-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• USC Norris Comprehensive Cancer Center — Los Angeles, California, United States (enrolling)
• Eastern Connecticut Hematology and Oncology Associates — Norwich, Connecticut, United States (enrolling)
• Health Partners Cancer Center at Regions Hospital — Saint Paul, Minnesota, United States (enrolling)
• Tennessee Oncology — Nashville, Tennessee, United States (enrolling)
• MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
• MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
• NEXT Dallas — Irving, Texas, United States (enrolling)
• NEXT Oncology — San Antonio, Texas, United States (enrolling)
• NEXT Virginia — Fairfax, Virginia, United States (enrolling)

Full record on ClinicalTrials.gov

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