What is the Purpose of this Study?
This study focuses on people with metastatic colorectal cancer. The purpose of the study is to evaluate the safety and effectiveness of an experimental drug called ivonescimab/SMT112 in combination with chemotherapy drugs (FOLFOX- oxaliplatin, leucovorin, and 5-fluorouracil) in the first-line treatment of metastatic colorectal cancer compared to bevacizumab in combination with chemotherapy drugs (FOLFOX). Bevacizumab is approved by the U.S. Food and Drug Administration) in combination with FOLFOX as the standard of care for metastatic colorectal cancer. Ivonescimab/SMT112 is an antibody designed to block proteins that help cancer cells grow and spread, potentially slowing cancer progression. Participants will be randomly assigned to 1 of 2 groups. One group will receive ivonescimab/SMT112 along with chemotherapy drugs. The other group will receive bevacizumab along with chemotherapy drugs. Study procedures also include lab work, exams, questionnaires, electrocardiogram, imaging, genetic testing, and biopsy.
Eligibility
- 1. ECOG performance status score of 0 or 1
- 2. Expected life expectancy ≥ 6 months
- 3. Patients with histologically or cytologically confirmed metastatic CRC
- 4. No prior systemic therapy for metastatic CRC
Where can I participate?
- CS Cancer at Beverly Hills : Abrahm Levi
- CS Cancer at Cedars-Sinai Medical Center : Abrahm Levi
- Hunt Cancer Institute, an Affiliate of Cedars-Sinai Cancer
More about this Clinical Trial
What is the full name of this clinical trial?
SMT112-3005: A Randomized, Active-Controlled, Double-blind, Multicenter, Phase 3 Clinical Study of Ivonescimab in Combination with FOLFOX versus Bevacizumab in Combination with FOLFOX for the First-line Treatment of Metastatic Colorectal Cancer