Study of RAS(ON) Inhibitors in Combination With Ivonescimab in Patients With Solid Tumors
About this study
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.
- Condition
- Advanced Solid Tumors, Metastatic Solid Tumors, Non-small Cell Lung Cancer (NSCLC), NSCLC, Colorectal Cancer (CRC), CRC
- Tested
- Daraxonrasib, Elironrasib, Zoldonrasib, Ivonescimab, Carboplatin/Cisplatin + Pemetrexed (Dose Expansion Only), cetuximab...
- Sponsor
- Revolution Medicines, Inc.
Who can join
- Age
- 18 years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
Inclusion 11
- Minimum age: 18 years
- Study condition: Advanced Solid Tumors, Metastatic Solid Tumors, Non-small Cell Lung Cancer (NSCLC), NSCLC, Colorectal Cancer (CRC), CRC
- 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 5
- 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
9 sites, 9 recruiting
NEXT Virginia
Fairfax, Virginia, United States
MD Anderson Cancer Center
Houston, Texas, United States
MD Anderson Cancer Center
Houston, Texas, United States
NEXT Dallas
Irving, Texas, United States
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States
Tennessee Oncology
Nashville, Tennessee, United States
and 3 more sites on ClinicalTrials.gov
Contact
-
Revolution Medicines Study Director
1-844-2-REVMED medinfo@revmed.com
Potential match only. Final eligibility is determined by the study team.