NCT05330429

Study of Magrolimab Given Together With FOLFIRI/Bevacizumab (BEV) in Participants With Previously Treated Advanced Inoperable Metastatic Colorectal Cancer (mCRC)

A Phase 2, Randomized, Open-Label Study Evaluating the Safety and Efficacy of Magrolimab in Combination With Bevacizumab and FOLFIRI Versus Bevacizumab and FOLFIRI in Previously Treated Advanced Inoperable Metastatic Colorectal Cancer (mCRC)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 77 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Metastatic Colorectal Cancer

Interventions

Type	Name	Description
DRUG	Magrolimab	Administered intravenous infusion
DRUG	Bevacizumab	Administered intravenous infusion
DRUG	Irinotecan	Administered intravenous infusion
DRUG	Fluorouracil	Administered intravenous infusion
DRUG	Leucovorin	Administered intravenous infusion

Timeline

• Start date: 2022-07-08
• Primary completion: 2024-06-26
• Completion: 2024-06-26
• First posted: 2022-04-15
• Last updated: 2025-07-01
• Results posted: 2025-07-01

Locations

51 sites across 10 countries: United States, Australia, Belgium, Canada, France, Germany, Hong Kong, Italy, Puerto Rico, Spain

Regulatory

• FDA-regulated drug study