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 (mCRC)

  • STATUS
    Recruiting
  • End date
    Nov 16, 2026
  • participants needed
    215
  • sponsor
    Gilead Sciences
Updated on 16 September 2022

Summary

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).

Details
Condition Metastatic Colorectal Cancer
Treatment fluorouracil, bevacizumab, Irinotecan, Leucovorin, Magrolimab
Clinical Study IdentifierNCT05330429
SponsorGilead Sciences
Last Modified on16 September 2022

Eligibility

Yes No Not Sure

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

Exclusion Criteria

Prior anticancer therapy including chemotherapy, hormonal therapy, or investigational agents within 3 weeks or within at least 4 half-lives prior to magrolimab 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 mutations or dMMR
Persistent Grade 2 or more gastrointestinal bleeding
Individuals with prior irinotecan therapy
Individuals without prior bevacizumab therapy for colorectal cancer
Clinically significant coronary artery disease or myocardial infarction within 6 months prior to inclusion
Peripheral neuropathy of more than Grade 1 (CTCAE Version 5.0)
Known dihydropyrimidine dehydrogenase deficiency
Acute intestinal obstruction or subobstruction, history of inflammatory intestinal disease or extended resection of the small intestine. Presence of a colic prosthesis
Unhealed wound, active gastric or duodenal ulcer, or bone fracture
History of abdominal fistulas, trachea-oesophageal fistulas, any other Grade 4 gastrointestinal perforations, nongastrointestinal fistulas, or intra-abdominal abscesses 6 months prior to screening
Uncontrolled arterial hypertension
Thromboembolic event in the 6 months before inclusion (eg, transitory ischemic stroke, stroke, subarachnoid hemorrhage) except peripheral deep vein thrombosis treated with anticoagulants
Active central nervous system (CNS) disease. Individuals with asymptomatic and stable, treated CNS lesions (radiation and/or surgery and/or other CNS-directed therapy who have not received corticosteroids for at least 4 weeks) are allowed
Red blood cell (RBC) transfusion dependence, defined as requiring more than 2 units of packed RBC transfusions during the 4-week period prior to screening
History of hemolytic anemia, autoimmune thrombocytopenia, or Evans syndrome in the last 3 months
Known hypersensitivity to any of the study drugs, the metabolites, or formulation excipient
Known inherited or acquired bleeding disorders
Significant disease or medical conditions, as assessed by the investigator and sponsor, that would substantially increase the risk-benefit ratio of participating in the study
Second malignancy, except treated basal cell or localized squamous skin carcinomas, or localized prostate cancer
Known active or chronic hepatitis B or C infection or HIV infection in medical history
Uncontrolled pleural effusion
Note: Other protocol defined Inclusion/Exclusion criteria may apply
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