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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)
Gilead Sciences, Inc.
This study has two parts. Part 1 (safety run-in) is evaluating how safe and tolerable, and determine the recommended Phase 2 dose (RP2D), of magrolimab + FOLFIRI. Participants in this cohort will receive magrolimab in de-escalating doses to establish the RP2D, in combination with bevacizumab (5mg/kg every 2 weeks) + FOLFIRI (irinotecan 180mg/m^2 + leucovorin 400mg/m^2 + fluorouracil 400mg/m^2 bolus followed by 2400mg/m^2 continuous on Days 1, 2, 15 and 16 of a 28-day cycle). Part 2 (randomised cohort) is further evaluating the effectiveness of this treatment. The second part has an Experimental Arm and an Active Comparator Arm. In the Experimental Arm, participants will receive the RP2D determined in the safety run-in cohort of magrolimab in combination with bevacizumab (5 mg/kg every 2 weeks) + FOLFIRI (irinotecan 180 mg/m^2 + leucovorin 400 mg/m^2 + fluorouracil 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous on Days 1, 2, 15, and 16 of a 28-Day Cycle). Additional dose expansion cohorts of magrolimab in combination with bevacizumab and FOLFIRI may be opened at the sponsor's discretion. In the Active Comparator Arm, participants will receive bevacizumab (5 mg/kg every 2 weeks) + FOLFIRI (irinotecan 180 mg/m^2 +leucovorin 400 mg/m^2 + fluorouracil 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous on Days 1, 2, 15, and 16 of a 28-Day Cycle). All treatments will be administered intravenously.