drugset / Trial / NCT05330429
Study of Magrolimab Given Together With FOLFIRI/Bevacizumab (BEV) in Participants With Previously Treated Advanced Inoperable Metastatic Colorectal Cancer (mCRC)
RandomizedSequentialOpen-labelTreatment
Summary
The goals of this clinical study are to learn more about the safety, tolerability and effectiveness of magrolimab in combination with bevacizumab and 5-fluorouracil, irinotecan, and leucovorin (FOLFIRI) in previously treated participants with advanced inoperable metastatic colorectal cancer (mCRC). The primary objectives of this study are: (safety run-in cohort) to evaluate safety and tolerability, and the recommended Phase 2 dose (RP2D) and (randomized cohort) to evaluate the efficacy of magrolimab in combination with bevacizumab and 5-fluorouracil, irinotecan, and leucovorin (FOLFIRI) in previously treated participants with advanced inoperable metastatic colorectal cancer (mCRC).
Timeline
- Start
- 2022-07-08
- Primary completion
- 2024-06-26
- Completion
- 2024-06-26
Publications
- Background Fakih MG, Tejani M, Ren X, Landes D, Werneke S, Curtis KK et al. 439TiP A phase II (ph2), randomized study of magrolimab with bevacizumab and FOLFIRI in previously treated patients with advanced inoperable metastatic colorectal cancer (mCRC). Annals of Oncology 2022; 33(7):S735.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Magrolimab | Monoclonal antibody | 30 mg/kg | Intravenous |
| Background | Bevacizumab | Monoclonal antibody | 5 mg/kg | Intravenous |
| Background | Irinotecan | Small molecule | 180 mg/m2 | Intravenous |
| Background | Leucovorin | Small molecule | 400 mg/m2 | Intravenous |
| Background | fluorouracil | Small molecule | 2400 mg/m2 | Intravenous |