What this study is
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's being tested
- Daraxonrasib
Intervention · DRUG
- Elironrasib
Intervention · DRUG
- Zoldonrasib
Intervention · DRUG
- Ivonescimab
Intervention · DRUG
- Carboplatin/Cisplatin + Pemetrexed (Dose Expansion Only)
Intervention · DRUG
- cetuximab (Cohort C2 Only)
Intervention · DRUG
- Carboplatin/Cisplatin + Pemetrexed (Cohort B2 Only)
Intervention · DRUG
- Daraxonrasib (Cohort B1 only)
Intervention · DRUG
All of Daraxonrasib, Elironrasib, Zoldonrasib, Daraxonrasib (Cohort B1 only)
oral tablets
All of Ivonescimab, Carboplatin/Cisplatin + Pemetrexed (Dose Expansion Only), cetuximab (Cohort C2 Only), Carboplatin/Cisplatin + Pemetrexed (Cohort B2 Only)
IV infusion
Study details
- Official title
- 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.
- Conditions
- Advanced Solid Tumors · Metastatic Solid Tumors · Non-small Cell Lung Cancer (NSCLC) · NSCLC · Colorectal Cancer (CRC) · CRC
- Enrolling
- 370 people
- Starts
- 2026-01-30
- Est. completion
- 2029-05
- Design
- Open-label, non-randomized, parallel groups, Phase 1, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou 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 can't join 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (19)
19 openHonor Health Research Institute
Scottsdale, Arizona, United States
- Christine Diab · Contact480-323-1350cdiab@honorhealth.com
RecruitingUSC Norris Comprehensive Cancer Center
Los Angeles, California, United States
- Lorraine Martinez Seng, RN · Contact323-865-0967Lorraine.Martinez@med.usc.edu
RecruitingUCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States
- Phu Lam · Contact415-613-2945phu.lam@ucsf.edu
RecruitingEastern Connecticut Hematology and Oncology Associates
Norwich, Connecticut, United States
- Spiro Curis · Contact860-886-8362 ext. ext 251Scuris@echoct.com
RecruitingUniversity of Kentucky HealthCare (UK HealthCare)
Lexington, Kentucky, United States
- Heather Pavlik · Contact859-323-2354heather.schroer@uky.edu
RecruitingHealth Partners Cancer Center at Regions Hospital
Saint Paul, Minnesota, United States
- Lisa Wahowske · Contact651-254-1517Lisa.A.Wahowske@HealthPartners.com
RecruitingSiteman Cancer Center
St Louis, Missouri, United States
- Alexis Cotton · Contact314-273-5919a.cotton@wustl.edu
RecruitingJohn Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, United States
- Joshua Zenreich · Contact551-996-1777oncologyresearchreferral@hmhn.org
RecruitingLaura & Isaac Perlmutter Cancer Center at NYU Langone Health - NYU POC
New York, New York, United States
- Contactcancertrials@nyulangone.org
RecruitingIcahn School of Medicine at Mount Sinai
New York, New York, United States
- Erin Mulhall · Contact212-241-1013erin.mulhall@mssm.edu
RecruitingUniversity Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
- Afshin Dowlati · Contact216-844-3951Afshin.Dowlati@uhhospitals.org
RecruitingThe Jame Outpatient Care West Campus
Columbus, Ohio, United States
- Jon Freshette · Contact614-685-7433john.frechette@osumc.edu
RecruitingOHSU Knight Cancer Institute
Portland, Oregon, United States
- Cassie Tompkins · Contact503-418-3451tompkica@ohsu.edu
RecruitingUPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
- Ana Palmer · Contact878-261-6102palmerah@upmc.edu
RecruitingTennessee Oncology
Nashville, Tennessee, United States
- Henry Black · Contact615-879-6410hblack@tnonc.com
RecruitingMD Anderson Cancer Center
Houston, Texas, United States
- Ly Nguyen · Contact832-794-3672LMNguyen1@mdanderson.org
RecruitingNEXT Dallas
Irving, Texas, United States
- Mofopefoluwa "Fope" Akinwale · Contact972-893-8800fakinwale@nextoncology.com
RecruitingNEXT Oncology
San Antonio, Texas, United States
- Jordan Georg · Contact210-580-9521jgeorg@nextoncology.com
RecruitingNEXT Virginia
Fairfax, Virginia, United States
- Maybelle De La Rosa · Contact703-783-4518mdelarosa@nextoncology.com
Recruiting
Study team
Sponsor
Revolution Medicines, Inc.
Study ID RMC-APEX-103
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.