Actively Recruiting
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
Led by Revolution Medicines, Inc. · Updated on 2026-05-12
370
Participants Needed
5
Research Sites
N/A
Total Duration
On this page
Sponsors
R
Revolution Medicines, Inc.
Lead Sponsor
S
Summit Therapeutics
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of RAS(ON) inhibitors combined with ivonescimab in adults with advanced or metastatic solid tumors that have a RAS mutation. This open-label, multicenter Phase 1/2 study aims to assess these treatments with or without other anti-cancer agents to better understand their effects in this patient population. The study includes three groups: Arm A tests daraxonrasib with ivonescimab; Arm B tests elironrasib with ivonescimab; and Arm C tests zoldonrasib with ivonescimab. Each arm has two parts: Part 1 focuses on finding safe and tolerable doses, while Part 2 explores safety, tolerability, and anti-tumor activity of the combinations with or without additional anti-cancer therapies such as carboplatin, cisplatin, pemetrexed, or cetuximab. Treatments include oral tablets and intravenous infusions given according to these groupings. Participants will be monitored for adverse events, vital signs, laboratory test changes, and dose-limiting toxicities for up to about four years. Researchers will also measure drug concentrations, tumor response rates, duration and control of disease, progression-free survival, and immune responses to ivonescimab. The study requires regular visits for assessments, and participation can last several years to thoroughly evaluate safety and treatment effects.
CONDITIONS
Brief Title
Study of RAS(ON) Inhibitors in Combination With Ivonescimab in Patients With Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 that has not received prior systemic treatment (Arms A & B for Part 2 Dose Expansion).
- Solid tumor or colorectal cancer 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 including bone marrow, liver, kidney, coagulation, and endocrine function.
- Able to take oral medications.
You will not qualify if you...
- 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.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 21-day cycles during dose exploration and dose expansion phases
Participants receive RAS(ON) inhibitors in combination with ivonescimab, with or without other anti-cancer agents, to evaluate safety, tolerability, and preliminary clinical activity.
Visits occur at the start of each 21-day treatment cycle, up to at least 6 cycles
Duration - Up to approximately 4 years
Participants are monitored for adverse events, clinical laboratory changes, and treatment response up to approximately 4 years after treatment.
Periodic follow-up visits during the monitoring period
Trial Site Locations
Total: 5 locations
1
Eastern Connecticut Hematology and Oncology Associates
Norwich, Connecticut, United States, 06360
Actively Recruiting
2
Tennessee Oncology
Nashville, Tennessee, United States, 37023
Actively Recruiting
3
NEXT Dallas
Irving, Texas, United States, 75039
Actively Recruiting
4
NEXT Oncology
San Antonio, Texas, United States, 78229
Actively Recruiting
5
NEXT Virginia
Fairfax, Virginia, United States, 22031
Actively Recruiting
Research Team
R
Revolution Medicines Study Director
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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