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Study of RAS(ON) Inhibitors with Ivonescimab for Advanced Solid Tumors

This study is testing new combinations of medicines for people with advanced or metastatic (spread to other parts of the body) solid tumors that have a specific genetic change called a RAS mutation (in KRAS, HRAS, or NRAS). You would receive one of three RAS(ON) inhibitor drugs (daraxonrasib, elironrasib, or zoldonrasib) as oral tablets, combined with ivonescimab given through an IV. Some participants may also receive additional anti-cancer therapies like Carboplatin/Cisplatin + Pemetrexed. The main goals are to see how safe these combinations are and how well your body tolerates them. Researchers will also look for early signs that the treatments are shrinking tumors. You must be at least 18 years old, have a good performance status (ECOG 0 or 1), and have tried and progressed on previous standard treatments. The study is currently unclear on its recruitment status and plans to enroll 370 participants.

Study design
This is an open-label, multicenter study, meaning both you and your doctors will know which treatment you are receiving. It is a Phase 1/2 study, which typically means it's an early-stage trial looking at safety and initial effectiveness. Approximately 370 participants are planned.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Researchers will monitor for side effects, changes in vital signs, and lab test values for up to approximately 4 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07397338

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Revolution Medicines, Inc.
~370 participants
Updated 2026-08-03 on ClinicalTrials.gov
What's tested:DaraxonrasibElironrasibZoldonrasibIvonescimabCarboplatin/Cisplatin + Pemetrexed (Dose Expansion Only)cetuximab (Cohort C2 Only)

At a glance

Recruiting sites
9 of 9 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of patients with adverse events (AEs)
Measured over Up to approximately 4 years
+3 more outcomes measured

Conditions

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

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Colorectal CarcinomaLung Non-Small Cell CarcinomaSolid NeoplasmRAS Family Oncogene

NCT07397338

Where you'd take part

This study runs at 9 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Eastern Connecticut Hematology and Oncology Associates

    Norwich, Connecticutstudy coordinator listed

    Recruiting

  • Health Partners Cancer Center at Regions Hospital

    Saint Paul, Minnesotastudy coordinator listed

    Recruiting

  • MD Anderson Cancer Center

    Houston, Texasstudy coordinator listed

    Recruiting

  • MD Anderson Cancer Center

    Houston, Texasstudy coordinator listed

    Recruiting

  • NEXT Dallas

    Irving, Texasstudy coordinator listed

    Recruiting

  • NEXT Oncology

    San Antonio, Texasstudy coordinator listed

    Recruiting

  • NEXT Virginia

    Fairfax, Virginiastudy coordinator listed

    Recruiting

  • Tennessee Oncology

    Nashville, Tennesseestudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Revolution Medicines Study Director
[email protected]
1-844-2-REVMED
Email the study team

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Number of patients with adverse events (AEs)Up to approximately 4 years

    Number of patients with AEs as assessed by CTCAE v5.

  • Changes in vital signsUp to approximately 4 years

    Number of patients with changes in vital signs.

  • Changes in clinical laboratory test valuesUp to approximately 4 years

    Number of patients with changes in clinical laboratory test values.

  • Dose Limiting Toxicities28 days

    Number of patients with dose limiting toxicities