RecruitingPhase 1Phase 2NCT07397338

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

A Phase 1/2 Open-Label, Multicenter Study of RAS(ON) Inhibitors in Combination With Ivonescimab With or Without Other Anti-Cancer Agents in Patients With Solid Tumors

Sponsor

Revolution Medicines, Inc.

Enrollment

370 participants

Start Date

Jan 30, 2026

Study Type

INTERVENTIONAL

Conditions

Non-small Cell Lung Cancer (NSCLC)Advanced Solid Tumors NSCLC CRC Metastatic Solid Tumors Colorectal Cancer (CRC)

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

Min Age: 18 Years

Inclusion Criteria9

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 Criteria4

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.