Study of RAS(ON) Inhibitors in Combination With Ivonescimab in Patients With Solid Tumors
Recruiting · NCT07397338 · Interventional (participants receive a specific treatment) · Lead sponsor: Revolution Medicines, Inc.
View the official record on ClinicalTrials.gov →Interventions studied
Carboplatin/Cisplatin + Pemetrexed (Cohort B2 Only)Carboplatin/Cisplatin + Pemetrexed (Dose Expansion Only)DaraxonrasibDaraxonrasib (Cohort B1 only)ElironrasibIvonescimabZoldonrasibcetuximab (Cohort C2 Only)
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1, Phase 2
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
9 locations listed across 6 US states.
- USC Norris Comprehensive Cancer Center - Los Angeles, California, United States
- Eastern Connecticut Hematology and Oncology Associates - Norwich, Connecticut, United States
- Health Partners Cancer Center at Regions Hospital - Saint Paul, Minnesota, United States
- Tennessee Oncology - Nashville, Tennessee, United States
- MD Anderson Cancer Center - Houston, Texas, United States
- MD Anderson Cancer Center - Houston, Texas, United States
- NEXT Dallas - Irving, Texas, United States
- NEXT Oncology - San Antonio, Texas, United States
- NEXT Virginia - Fairfax, Virginia, United States