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

RecruitingPhase 1/2

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

Who can join

Ages 18 and older · All sexes

Full 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.

About the study

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.

What is being tested

Sponsor: Revolution Medicines, Inc. · Participants: 370 · Started: Jan 30, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07397338

Locations in the U.S.

CaliforniaUSC Norris Comprehensive Cancer Center, Los Angeles
ConnecticutEastern Connecticut Hematology and Oncology Associates, Norwich
MinnesotaHealth Partners Cancer Center at Regions Hospital, Saint Paul
TennesseeTennessee Oncology, Nashville
TexasMD Anderson Cancer Center, Houston
MD Anderson Cancer Center, Houston
NEXT Dallas, Irving
NEXT Oncology, San Antonio
VirginiaNEXT Virginia, Fairfax

Conditions

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.