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)

Korábbi kezelés

• 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.
• History of abdominal fistulas, trachea-oesophageal fistulas, any other Grade 4 gastrointestinal perforations, nongastrointestinal fistulas, or intra-abdominal abscesses 6 months prior to screening.
• 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.
• Individuals with prior irinotecan therapy.
• Clinically significant coronary artery disease or myocardial infarction within 6 months prior to inclusion.

Más betegség

• Acute intestinal obstruction or subobstruction, history of inflammatory intestinal disease or extended resection of the small intestine. Presence of a colonic prosthesis.
• Unhealed wound, active gastric or duodenal ulcer, or bone fracture.
• Uncontrolled arterial hypertension.
• History of hemolytic anemia, autoimmune thrombocytopenia, or Evans syndrome in the last 3 months.
• 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.
• Known hypersensitivity to any of the study drugs, the metabolites, or formulation excipient.
• Known inherited or acquired bleeding disorders.
• Second malignancy, except treated basal cell or localized squamous skin carcinomas, or localized prostate cancer
• Persistent Grade 2 or more gastrointestinal bleeding.

Egyéb

• Known dihydropyrimidine dehydrogenase deficiency.
• Note: Other protocol defined Exclusion criteria may apply.
• Known v-raf murine sarcoma viral oncogene homolog B1 (BRAF) V600E or MSI-H mutations or dMMR.
• Uncontrolled pleural effusion.
• Peripheral neuropathy of more than Grade 2 (CTCAE Version 5.0).

• 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 in the setting where curative resection is not indicated. This therapy must have included chemotherapy based on 5-FU or capecitabine with oxaliplatin and either bevacizumab, or for patients with RAS wild-type and left-sided tumors, bevacizumab, cetuximab, or panitumumab.
• 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
• Note: Other protocol defined Inclusion criteria may apply