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

Part of paid clinical trials in Duarte, California.

Sponsor
Gilead Sciences
Study ID
NCT05330429
Phase
PHASE2
Status
Terminated

Conditions

  • Metastatic Colorectal Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Magrolimab — DRUG
    Administered intravenous infusion
  • Bevacizumab — DRUG
    Administered intravenous infusion
  • Irinotecan — DRUG
    Administered intravenous infusion
  • Fluorouracil — DRUG
    Administered intravenous infusion
  • Leucovorin — DRUG
    Administered intravenous infusion

Study Details

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).

Key Dates

Start date
Jul 8, 2022
Status verified
Jun 2025
Primary completion
Jun 26, 2024
Completion
Jun 26, 2024

Study Design

Enrollment
77 participants (actual)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Safety Run-in Cohort: Magrolimab + Bevacizumab + FOLFIRI
    Participants will receive magrolimab + bevacizumab + FOLFIRI as mentioned below: * Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, every week (QW) beginning at Day 8 and for the next 6 doses (Cycle 1 Days 8, 15, and 22, and Cycle 2 Days 1, 8, 15, and 22); 30 mg/kg, every 2 weeks (Q2W) beginning 1 week after the last weekly 30 mg/kg dose (starting Cycle 3 Day 1 onwards) for every 28-day cycle. * Bevacizumab: 5 mg/kg, Q2W (Days 1 and 15) of every 28-day cycle. * FOLFIRI (Irinotecan 180 mg/m\^2 + leucovorin 400 mg/m\^2 + fluorouracil 400 mg/m\^2 IV bolus on first day, followed by 2400 mg/m\^2 over the next 46 hours, Q2W (Days 1 and 15) of every 28-day cycle.
  • Experimental: Randomized Cohort: Magrolimab + Bevacizumab + FOLFIRI
    Participants will receive magrolimab + bevacizumab + FOLFIRI as mentioned below: * Magrolimab 1 mg/kg on Cycle 1 Day 1; 30 mg/kg, QW beginning at Day 8 and for the next 6 doses (Cycle 1 Days 8, 15, and 22, and Cycle 2 Days 1, 8, 15, and 22); 30 mg/kg, Q2W beginning 1 week after the last weekly 30 mg/kg dose (starting Cycle 3 Day 1 onwards) for every 28-day cycle. * Bevacizumab: 5 mg/kg, Q2W (Days 1 and 15) of every 28-day cycle. * FOLFIRI (Irinotecan 180 mg/m\^2 + leucovorin 400 mg/m\^2 + fluorouracil 400 mg/m\^2 IV bolus on first day, followed by 2400 mg/m\^2 over the next 46 hours, Q2W (Days 1 and 15) of every 28-day cycle.
  • Active Comparator: Randomized Cohort: Bevacizumab + FOLFIRI
    Participants will receive bevacizumab + FOLFIRI as mentioned below: * Bevacizumab: 5 mg/kg, Q2W (Days 1 and 15) of every 28-day cycle. * FOLFIRI (Irinotecan 180 mg/m\^2 + leucovorin 400 mg/m\^2 + fluorouracil 400 mg/m\^2 IV bolus on first day, followed by 2400 mg/m\^2 over the next 46 hours, Q2W (Days 1 and 15) of every 28-day cycle.

Primary Outcome Measure

Safety Run-in Cohort: Number of Participants Experiencing Dose-limiting Toxicities (DLTs) According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 [ Time Frame: First dose date up to 28 days ]

Locations (20)

FacilityCityStateZIPSite coordinators
City of Hope ( City of Hope National Medical Center, City of Hope Medical Center )DuarteCalifornia91010-
USC Norris Comprehensive Cancer CenterLos AngelesCalifornia90033-
Stanford Cancer CenterPalo AltoCalifornia94305-
Torrance Memorial Physician NetworkRedondo BeachCalifornia90277-
University of California Los Angeles (UCLA)Santa MonicaCalifornia90095-
Orlando Health Cancer InstituteOrlandoFlorida32806-
Fort Wayne Medical Oncology and Hematology, Inc.Fort WayneIndiana46845-
University of KansasWestwoodKansas66205-
University of MichiganAnn ArborMichigan48106-
Roswell Park Cancer InstituteBuffaloNew York14263-
Hematology Oncology Associates of Central New York, PCEast SyracuseNew York13057-
AdventHealthRochesterNew York14642-
Fox Chase Cancer CenterPhiladelphiaPennsylvania19111-
Pennsylvania HospitalPhiladelphiaPennsylvania19104-
Avera Cancer InstituteSioux FallsSouth Dakota57105-
Sarah Cannon Research InstituteNashvilleTennessee327203-
Texas OncologyDallasTexas75246-
Baylor College of Medicine Medical CenterHoustonTexas77030-
Virginia Cancer Specialists, PCArlingtonVirginia22205-
Seattle Cancer Care Alliance (SCCA)SeattleWashington98103-

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By research site
City of Hope ( City of Hope National Medical Center, City of Hope Medical Center )· Duarte, CAUSC Norris Comprehensive Cancer Center· Los Angeles, CAStanford Cancer Center· Palo Alto, CATorrance Memorial Physician Network· Redondo Beach, CAUniversity of California Los Angeles (UCLA)· Santa Monica, CAOrlando Health Cancer Institute· Orlando, FL

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