What is the Purpose of this Study?
Primary Objective: To compare the progression-free survival (PFS) as assessed by blinded Independent Radiological Review Committee (IRRC) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, of ivonescimab in combination with modified 5-FU, oxaliplatin, and leucovorin (mFOLFOX6) to bevacizumab in combination with mFOLFOX6. Secondary Objectives: - To compare the overall survival (OS) of ivonescimab in combination with mFOLFOX6 to bevacizumab in combination with mFOLFOX6. - To compare objective response rate (ORR) including duration of response (DOR) as assessed by blinded IRRC based on RECIST v1.1, of ivonescimab in combination with mFOLFOX6 to bevacizumab plus mFOLFOX6. - To compare the safety and tolerability of ivonescimab in combination with mFOLFOX6 to bevacizumab in combination with mFOLFOX6. - To evaluate the pharmacokinetic (PK) profile of ivonescimab in combination with mFOLFOX6. - To evaluate the immunogenicity of ivonescimab in combination with mFOLFOX6.
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
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