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)
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Clinical Trial Information
Trial Contact: Djuro, Victor; Donaldson, Karin M
Trial Phone: 321.841.7477 ; 321.841.9821
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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
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Objective
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
Randomized Cohort:
- To evaluate the efficacy of magrolimab in combination with bevacizumab and FOLFIRI in mCRC as determined by PFS by investigator assessment -
Key Eligibility
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
