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

    Trial Phone: 321.841.7477 ; 321.841.9821

  • 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 ID: NCT05330429

  • 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