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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)

Description

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).

Status

Accepting new patients

Primary Study Objective(s)

The primary objective of this trial for the safety run-in cohort is to determine the:

  • Percentage of participants experiencing dose-limiting toxicities
  • Percentage of participants experiencing adverse events
  • Percentage of participants experiencing laboratory abnormalities

The primary objective of this trial for the randomized cohort is to determine:

  • Progression-free survival

Core eligibility

Note: This is only a partial list of eligibility criteria.

Including patients who meet these 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

Excluding patients who meet these 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 six 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 two 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 and exclusion criteria may apply.

     

Accepting new patients

 

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