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

Last updated: July 22, 2024
Sponsor: Gilead Sciences
Overall Status: Terminated

Phase

2

Condition

Colorectal Cancer

Metastatic Cancer

Treatment

Magrolimab

Fluorouracil

Leucovorin

Clinical Study ID

NCT05330429
GS-US-587-6156
2022-500177-13-00
2022-500177-13
  • Ages > 18
  • All Genders

Study Summary

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).

Eligibility Criteria

Inclusion

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 orrectum (excluding appendiceal and anal canal cancers) who have progressed on orafter 1 prior systemic therapy in the setting where curative resection is notindicated. This therapy must have included chemotherapy based on 5-FU orcapecitabine with oxaliplatin and either bevacizumab, or for patients with RASwild-type and left-sided tumors, bevacizumab, cetuximab, or panitumumab.

  • Measurable disease (RECIST V1.1 criteria).

  • Individuals must have an eastern cooperative oncology group (ECOG) performancestatus of 0 or 1.

  • Life expectancy of at least 12 weeks.

  • Laboratory measurements, blood counts: adequate hemoglobin, neutrophil, and plateletcounts

  • Adequate liver function.

  • Adequate renal function.

Exclusion

Key Exclusion Criteria:

  • Prior anticancer therapy including chemotherapy, hormonal therapy, orinvestigational agents within 3 weeks or within at least 4 half-lives prior tomagrolimab dosing (up to a maximum of 4 weeks), whichever is shorter.

  • Known v-raf murine sarcoma viral oncogene homolog B1 (BRAF) V600E or MSI-H mutationsor dMMR.

  • Persistent Grade 2 or more gastrointestinal bleeding.

  • Individuals with prior irinotecan therapy.

  • Clinically significant coronary artery disease or myocardial infarction within 6months prior to inclusion.

  • Peripheral neuropathy of more than Grade 2 (CTCAE Version 5.0).

  • Known dihydropyrimidine dehydrogenase deficiency.

  • Acute intestinal obstruction or subobstruction, history of inflammatory intestinaldisease or extended resection of the small intestine. Presence of a colonicprosthesis.

  • Unhealed wound, active gastric or duodenal ulcer, or bone fracture.

  • History of abdominal fistulas, trachea-oesophageal fistulas, any other Grade 4gastrointestinal perforations, nongastrointestinal fistulas, or intra-abdominalabscesses 6 months prior to screening.

  • Uncontrolled arterial hypertension.

  • Thromboembolic event in the 6 months before inclusion (eg, transitory ischemicstroke, stroke, subarachnoid hemorrhage) except peripheral deep vein thrombosistreated with anticoagulants.

  • Active central nervous system (CNS) disease. Individuals with asymptomatic andstable, treated CNS lesions (radiation and/or surgery and/or other CNS-directedtherapy who have not received corticosteroids for at least 4 weeks) are allowed.

  • Red blood cell (RBC) transfusion dependence, defined as requiring more than 2 unitsof packed RBC transfusions during the 4-week period prior to screening.

  • History of hemolytic anemia, autoimmune thrombocytopenia, or Evans syndrome in thelast 3 months.

  • Known hypersensitivity to any of the study drugs, the metabolites, or formulationexcipient.

  • Known inherited or acquired bleeding disorders.

  • Significant disease or medical conditions, as assessed by the investigator andsponsor, that would substantially increase the risk-benefit ratio of participatingin the study.

  • Second malignancy, except treated basal cell or localized squamous skin carcinomas,or localized prostate cancer.

  • Uncontrolled pleural effusion.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Design

Total Participants: 77
Treatment Group(s): 5
Primary Treatment: Magrolimab
Phase: 2
Study Start date:
July 08, 2022
Estimated Completion Date:
June 26, 2024

Connect with a study center

  • Westmead Hospital

    Blacktown, New South Wales 2148
    Australia

    Site Not Available

  • Kinghorn Cancer Centre

    Darlinghurst, New South Wales 2010
    Australia

    Site Not Available

  • Southside Cancer Care Centre

    Kogarah, New South Wales 2217
    Australia

    Site Not Available

  • Southside Cancer Care Centre

    Miranda, New South Wales 2228
    Australia

    Site Not Available

  • Genesis Care North Shore

    St Leonards, New South Wales 2065
    Australia

    Site Not Available

  • Princess Alexandra Hospital

    Woolloongabba, Queensland 4102
    Australia

    Site Not Available

  • Flinders Medical Centre

    Bedford Park, South Australia 5042
    Australia

    Site Not Available

  • Austin Health

    Heidelberg, Victoria 3084
    Australia

    Site Not Available

  • The Alfred Hospital

    Melbourne, Victoria 3004
    Australia

    Site Not Available

  • Hôpital de Jolimont

    Haine-Saint-Paul, 7100
    Belgium

    Site Not Available

  • Centre Hospitalizer De L'Ardenne

    Libramont-Chevigny, 6800
    Belgium

    Site Not Available

  • The Ottawa Hospital Cancer Centre

    Ottawa, K1H 8L6
    Canada

    Site Not Available

  • Princess Margaret Cancer Centre

    Toronto, M5G 1X6
    Canada

    Site Not Available

  • Centre Hospitalier Regional Universitaire Hopital Besancon

    Besançon, 25030
    France

    Site Not Available

  • Centre Léon Bérard - Centre de Lutte contre le Cancer

    Lyon, 69008
    France

    Site Not Available

  • Hopital franco brittanique

    Paris, 75012
    France

    Site Not Available

  • CHU de Tours

    Tours, 37000
    France

    Site Not Available

  • Carl Gustav Carus Management GMBH

    Dresden, 01307
    Germany

    Site Not Available

  • Klinikum rechts der Isar der TU Munchen Zentrum fur klinische Studien der Klinik und Poliklinik fur Innere Medizin III

    Munchen, 81675
    Germany

    Site Not Available

  • Hong Kong Integrated Oncology Centre

    Hong Kong, 0
    Hong Kong

    Site Not Available

  • Hong Kong United Oncology Center

    Hong Kong,
    Hong Kong

    Site Not Available

  • Queen Mary Hospital

    Hong Kong,
    Hong Kong

    Site Not Available

  • Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - Medical Oncology Department

    Meldola, 47014
    Italy

    Site Not Available

  • Istituto Oncologico Veneto (IOV)- IRCCS

    Padova, 35128
    Italy

    Site Not Available

  • Azienda Ospedaliera Universitaria Pisana- UO Oncologia Medica

    Pisa, 56126
    Italy

    Site Not Available

  • Istituto di Ricovero e Cura a Carattere Scientifico - Istituto Clinico Humanitas

    San Giovanni Rotondo, 71013
    Italy

    Site Not Available

  • San Bortolo General Hospital- Oncology Department

    Vicenza, 36100
    Italy

    Site Not Available

  • Pan American Center for Oncology Trials, LLC

    San Juan, 00902
    Puerto Rico

    Site Not Available

  • Hospital Universitari Vall d'Hebron

    Barcelona, 8035
    Spain

    Site Not Available

  • Institut Català d'Oncologia- Hospital Duran I Reynals

    L'Hospitalet de Llobregat, 8908
    Spain

    Site Not Available

  • Hospital General Universitario Gregorio Marañón

    Madrid, 28007
    Spain

    Site Not Available

  • Hospital HM Sanchinarro

    Madrid, 28050
    Spain

    Site Not Available

  • Hospital Universitario 12 de Octubre

    Madrid, 28041
    Spain

    Site Not Available

  • City of Hope ( City of Hope National Medical Center, City of Hope Medical Center )

    Duarte, California 91010
    United States

    Site Not Available

  • USC Norris Comprehensive Cancer Center

    Los Angeles, California 90033
    United States

    Site Not Available

  • Stanford Cancer Center

    Palo Alto, California 94305
    United States

    Site Not Available

  • Torrance Memorial Physician Network

    Redondo Beach, California 90277
    United States

    Site Not Available

  • University of California Los Angeles (UCLA)

    Santa Monica, California 90095
    United States

    Site Not Available

  • Orlando Health Cancer Institute

    Orlando, Florida 32806
    United States

    Site Not Available

  • Fort Wayne Medical Oncology and Hematology, Inc.

    Fort Wayne, Indiana 46845
    United States

    Site Not Available

  • Seattle Cancer Care Alliance (SCCA)

    Indianapolis, Indiana 46202
    United States

    Site Not Available

  • University of Kansas

    Westwood, Kansas 66205
    United States

    Site Not Available

  • University of Michigan

    Ann Arbor, Michigan 48106
    United States

    Site Not Available

  • Roswell Park Cancer Institute

    Buffalo, New York 14263
    United States

    Site Not Available

  • Hematology Oncology Associates of Central New York, PC

    East Syracuse, New York 13057
    United States

    Site Not Available

  • AdventHealth

    Rochester, New York 14642
    United States

    Site Not Available

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania 19111
    United States

    Site Not Available

  • Pennsylvania Hospital

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Avera Cancer Institute

    Sioux Falls, South Dakota 57105
    United States

    Site Not Available

  • Sarah Cannon Research Institute

    Nashville, Tennessee 327203
    United States

    Site Not Available

  • Texas Oncology

    Dallas, Texas 75246
    United States

    Site Not Available

  • Baylor College of Medicine Medical Center

    Houston, Texas 77030
    United States

    Site Not Available

  • Virginia Cancer Specialists, PC

    Arlington, Virginia 22205
    United States

    Site Not Available

  • Seattle Cancer Care Alliance (SCCA)

    Seattle, Washington 98103
    United States

    Site Not Available

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