NCT07397338RecruitingPhase 1/2
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
Source: ClinicalTrials.gov · Last updated 3 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 370 (estimated)
- First submitted
- 2 Feb 2026
- Start date
- 30 Jan 2026
- Primary completion date
- 31 May 2029
- Lead sponsor
- Revolution Medicines, Inc.
- Diseases
- Lung cancer, Colorectal cancer
- NCT number
- NCT07397338
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 370
- From 30 Jan 2026 to the primary completion date, 31 May 2029
- 8 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Major surgery within 4 weeks prior to receiving study drug(s).
Other illness
- Any conditions that may affect the ability to take or absorb study drug.
Other
- Head and neck squamous cell carcinoma.
- Patient is unable or unwilling to comply with protocol-required study visits or procedures.
- Other inclusion/exclusion criteria may apply.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (8)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| NEXT Virginia Coordinator of this site? Confirm its status | Fairfax | United States | Recruiting |
| MD Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| NEXT Dallas Coordinator of this site? Confirm its status | Irving | United States | Recruiting |
| USC / Norris Comprehensive Cancer Center Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| Tennessee Oncology Coordinator of this site? Confirm its status | Nashville | United States | Recruiting |
| Eastern Connecticut Hematology and Oncology Associates Coordinator of this site? Confirm its status | Norwich | United States | Recruiting |
| Health Partners Cancer Center at Regions Hospital Coordinator of this site? Confirm its status | Saint Paul | United States | Recruiting |
| NEXT Oncology Coordinator of this site? Confirm its status | San Antonio | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.