Phase 1 Study Of SAR445877 In Combination With FOLFOX6 And Bevacizumab As First-Line Treatment For Microsatellite Stable Metastatic Colorectal Cancer
M.D. Anderson Cancer Center
Summary
To learn if SAR445877 in combination with FOLFOX6 and bevacizumab can be safely given to patients with advanced MSS CRC.
Description
Primary Objective •To determine the safety, tolerability, maximum tolerated dose (MTD), and recommended Phase 2 dose (RP2D) of SAR445877 + FOLFOX6 and bevacizumab in patients with MSS metastatic CRC. Secondary Objective •To evaluate the antitumor efficacy of SAR445877 + FOLFOX6 and bevacizumab in participants with MSS metastatic CRC.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Eligibility Criteria 1. Ability to understand and willingness to sign informed consent form prior to initiation of the study and any study procedures. 2. Capable of and willing to comply with scheduled visits, treatment plans, laboratory tests, and other study-related tests and procedures. 3. Age ≥18 years. 4. Participants with histologically documented CRC with metastatic disease who have not received prior treatment in the metastatic setting. Participants who have received adjuvant FOLFOX must be 6 months from treatment at the time of enrollment. 5. CRC documented as MSS by immunohistochemi…
Interventions
- DrugSAR445877
Given by IV
- DrugFOLFOX6
Given by IV
- DrugBevacizumab
Given by IV
Location
- MD Anderson Cancer CenterHouston, Texas