Study of Magrolimab Given Together With FOLFIRI/BEV in Patients With Previously Treated Advanced Inoperable Metastatic Colorectal Cancer (mCRC)
Trial ID or NCT#
Status
NOT RECRUITING
Purpose
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).
Official Title
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)
Eligibility 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 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.
- Key
- * 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.* Clinically significant coronary artery disease or myocardial infarction within 6 months 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 intestinal disease or extended resection of the small intestine. Presence of a colonic 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.* Uncontrolled pleural effusion.
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Investigator(s)
Contact us to find out if this trial is right for you.
Contact
gitrialeligibility@stanford.edu
gitrialeligibility@stanford.edu
View on ClinicalTrials.gov
