Phase 2, Magrolimab plus FOLFIRI/BEV in 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 (CRC)
Clinical Trial Information
Trial Contact: Djuro, Victor; Donaldson, Karin M
IRB No: WCG 20220977
Protocol Abbrev: TRIO GS-US-587-6156
Principal Investigator: Omar R. Kayaleh, MD
Phase: Drug: Phase II
Age Group: Adult
Secondary Protocol No: GS-US-587-6156
Treatment: Drug: Magrolimab Drug: Bevacizumab Drug: Irinotecan Drug: Fluorouracil Drug: Leucovorin
Therapies Involved: Chemotherapy
ClinicalTrials.gov ID: NCT05330429
Safety Run-in Cohort:
-To evaluate the safety, tolerability, and recommended Phase 2 dose (RP2D) of magrolimab in combination with bevacizumab and FOLFIRI in previously treated patients with advanced inoperable mCRC
- To evaluate the efficacy of magrolimab in combination with bevacizumab and FOLFIRI in mCRC as determined by PFS by investigator assessment
Key Inclusion Criteria:
-Previously treated individuals with inoperable metastatic colorectal cancer (mCRC) who are ineligible for checkpoint inhibitor therapy (microsatellite instability (MSI)-H or mismatch repair deficient (dMMR) and are excluded).
-Histologically or cytologically confirmed adenocarcinoma originating in the colon or rectum (excluding appendiceal and anal canal cancers), who have progressed on or after 1 prior systemic therapy with chemotherapy based on 5-fluorouracil (5-FU) with oxaliplatin and bevacizumab.
-Measurable disease (RECIST V1.1 criteria)
-Individuals must have an eastern cooperative oncology group (ECOG) performance status of 0 or 1.
-Life expectancy of at least 12 weeks.
-Laboratory measurements, blood counts: adequate hemoglobin, neutrophil, and platelet counts
-Adequate liver function
-Adequate renal function