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Clinical Trials in the USA / NCT07397338
Recruiting Phase 1/2

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

NCT07397338 · tracked via the Priya Life Science USA tracker
Sponsor
Revolution Medicines, Inc
Phase
Phase 1/2
Started
2026-01-30
Last updated
2026-08-03

Condition(s) studied

Advanced Solid TumorsMetastatic Solid TumorsNon-small Cell Lung Cancer (NSCLC)NSCLCColorectal Cancer (CRC)CRC

Investigational drug(s) / intervention(s)

Daraxonrasib →Elironrasib →Zoldonrasib →Ivonescimab →Carboplatin/Cisplatin + Pemetrexed (Dose Expansion Only)All Ivonescimab trials (109) →All Pemetrexed trials (251) →cetuximab (Cohort C2 Only) →Carboplatin/Cisplatin + Pemetrexed (Cohort B2 Only)All Ivonescimab trials (109) →All Pemetrexed trials (251) →Daraxonrasib (Cohort B1 only) →

Daraxonrasib: oral tablets

Elironrasib: oral tablets

Zoldonrasib: oral tablets

Ivonescimab: IV infusion

Carboplatin/Cisplatin + Pemetrexed (Dose Expansion Only): IV infusion

cetuximab (Cohort C2 Only): IV infusion

Carboplatin/Cisplatin + Pemetrexed (Cohort B2 Only): IV infusion

Daraxonrasib (Cohort B1 only): oral tablets

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • 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 signs — Up to approximately 4 years
    Number of patients with changes in vital signs.
  • Changes in clinical laboratory test values — Up to approximately 4 years
    Number of patients with changes in clinical laboratory test values.
  • Dose Limiting Toxicities — 28 days
    Number of patients with dose limiting toxicities

Trial sites (9)

FacilityCityRegionStatus
USC Norris Comprehensive Cancer Center Los Angeles California Recruiting
Eastern Connecticut Hematology and Oncology Associates Norwich Connecticut Recruiting
Health Partners Cancer Center at Regions Hospital Saint Paul Minnesota Recruiting
Tennessee Oncology Nashville Tennessee Recruiting
MD Anderson Cancer Center Houston Texas Recruiting
MD Anderson Cancer Center Houston Texas Recruiting
NEXT Dallas Irving Texas Recruiting
NEXT Oncology San Antonio Texas Recruiting
NEXT Virginia Fairfax Virginia Recruiting

More Revolution Medicines, Inc. trials in the USA

Study of Daraxonrasib and Daraxonrasib + GnP as First-line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma Recruiting
Study of RMC-9805 in Participants With KRAS G12D-Mutant Solid Tumors Recruiting
Study of RMC-5127 in Patients With Advanced KRAS G12V-Mutant Solid Tumors Recruiting
Study of Daraxonrasib (RMC-6236) in Patients With Resected Pancreatic Ductal Adenocarcinoma (PDAC) Recruiting
Study of Pembrolizumab + Pemetrexed + Platinum Chemotherapy With or Without Zoldonrasib as First Line Treatment in Metastatic Non-squamous RAS G12D-Mutated NSCLC Recruiting

Other trials for the same condition

Study to Evaluate Adverse Events, Change in Disease Activity, and How ABBV-706 Moves Through the Body When Intravenously (IV) Infused Alone or in Combination With IV Infused Budigalimab, Cisplatin, or Carboplatin in Adult Participants With Advanced Solid Tumors Active, not recruiting
A Study of MT-4561 in Patients With Various Advanced Solid Tumors Recruiting
Study of GS-2426 in Participants With Advanced Solid Tumors Recruiting
U3-1402 in Metastatic or Unresectable Non-Small Cell Lung Cancer Active, not recruiting
Study of Oral MRT-2359 in Selected Cancer Patients Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07397338 on ClinicalTrials.gov ↗ ← All trials in the USA