Phase
Condition
Colorectal Cancer
Metastatic Cancer
Treatment
Magrolimab
Fluorouracil
Leucovorin
Clinical Study ID
Ages > 18 All Genders
Study Summary
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
Connect with a study center
Westmead Hospital
Blacktown, New South Wales 2148
AustraliaSite Not Available
Kinghorn Cancer Centre
Darlinghurst, New South Wales 2010
AustraliaSite Not Available
Southside Cancer Care Centre
Kogarah, New South Wales 2217
AustraliaSite Not Available
Southside Cancer Care Centre
Miranda, New South Wales 2228
AustraliaSite Not Available
Genesis Care North Shore
St Leonards, New South Wales 2065
AustraliaSite Not Available
Princess Alexandra Hospital
Woolloongabba, Queensland 4102
AustraliaSite Not Available
Flinders Medical Centre
Bedford Park, South Australia 5042
AustraliaSite Not Available
Austin Health
Heidelberg, Victoria 3084
AustraliaSite Not Available
The Alfred Hospital
Melbourne, Victoria 3004
AustraliaSite Not Available
Hôpital de Jolimont
Haine-Saint-Paul, 7100
BelgiumSite Not Available
Centre Hospitalizer De L'Ardenne
Libramont-Chevigny, 6800
BelgiumSite Not Available
The Ottawa Hospital Cancer Centre
Ottawa, K1H 8L6
CanadaSite Not Available
Princess Margaret Cancer Centre
Toronto, M5G 1X6
CanadaSite Not Available
Centre Hospitalier Regional Universitaire Hopital Besancon
Besançon, 25030
FranceSite Not Available
Centre Léon Bérard - Centre de Lutte contre le Cancer
Lyon, 69008
FranceSite Not Available
Hopital franco brittanique
Paris, 75012
FranceSite Not Available
CHU de Tours
Tours, 37000
FranceSite Not Available
Carl Gustav Carus Management GMBH
Dresden, 01307
GermanySite Not Available
Klinikum rechts der Isar der TU Munchen Zentrum fur klinische Studien der Klinik und Poliklinik fur Innere Medizin III
Munchen, 81675
GermanySite Not Available
Hong Kong Integrated Oncology Centre
Hong Kong, 0
Hong KongSite Not Available
Hong Kong United Oncology Center
Hong Kong,
Hong KongSite Not Available
Queen Mary Hospital
Hong Kong,
Hong KongSite Not Available
Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - Medical Oncology Department
Meldola, 47014
ItalySite Not Available
Istituto Oncologico Veneto (IOV)- IRCCS
Padova, 35128
ItalySite Not Available
Azienda Ospedaliera Universitaria Pisana- UO Oncologia Medica
Pisa, 56126
ItalySite Not Available
Istituto di Ricovero e Cura a Carattere Scientifico - Istituto Clinico Humanitas
San Giovanni Rotondo, 71013
ItalySite Not Available
San Bortolo General Hospital- Oncology Department
Vicenza, 36100
ItalySite Not Available
Pan American Center for Oncology Trials, LLC
San Juan, 00902
Puerto RicoSite Not Available
Hospital Universitari Vall d'Hebron
Barcelona, 8035
SpainSite Not Available
Institut Català d'Oncologia- Hospital Duran I Reynals
L'Hospitalet de Llobregat, 8908
SpainSite Not Available
Hospital General Universitario Gregorio Marañón
Madrid, 28007
SpainSite Not Available
Hospital HM Sanchinarro
Madrid, 28050
SpainSite Not Available
Hospital Universitario 12 de Octubre
Madrid, 28041
SpainSite Not Available
City of Hope ( City of Hope National Medical Center, City of Hope Medical Center )
Duarte, California 91010
United StatesSite Not Available
USC Norris Comprehensive Cancer Center
Los Angeles, California 90033
United StatesSite Not Available
Stanford Cancer Center
Palo Alto, California 94305
United StatesSite Not Available
Torrance Memorial Physician Network
Redondo Beach, California 90277
United StatesSite Not Available
University of California Los Angeles (UCLA)
Santa Monica, California 90095
United StatesSite Not Available
Orlando Health Cancer Institute
Orlando, Florida 32806
United StatesSite Not Available
Fort Wayne Medical Oncology and Hematology, Inc.
Fort Wayne, Indiana 46845
United StatesSite Not Available
Seattle Cancer Care Alliance (SCCA)
Indianapolis, Indiana 46202
United StatesSite Not Available
University of Kansas
Westwood, Kansas 66205
United StatesSite Not Available
University of Michigan
Ann Arbor, Michigan 48106
United StatesSite Not Available
Roswell Park Cancer Institute
Buffalo, New York 14263
United StatesSite Not Available
Hematology Oncology Associates of Central New York, PC
East Syracuse, New York 13057
United StatesSite Not Available
AdventHealth
Rochester, New York 14642
United StatesSite Not Available
Fox Chase Cancer Center
Philadelphia, Pennsylvania 19111
United StatesSite Not Available
Pennsylvania Hospital
Philadelphia, Pennsylvania 19104
United StatesSite Not Available
Avera Cancer Institute
Sioux Falls, South Dakota 57105
United StatesSite Not Available
Sarah Cannon Research Institute
Nashville, Tennessee 327203
United StatesSite Not Available
Texas Oncology
Dallas, Texas 75246
United StatesSite Not Available
Baylor College of Medicine Medical Center
Houston, Texas 77030
United StatesSite Not Available
Virginia Cancer Specialists, PC
Arlington, Virginia 22205
United StatesSite Not Available
Seattle Cancer Care Alliance (SCCA)
Seattle, Washington 98103
United StatesSite Not Available
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