Overview

Study of Magrolimab Given Together With FOLFIRI/BEV in Participants With Previously Treated Advanced Inoperable Metastatic Colorectal Cancer (mCRC)

Status:
Not yet recruiting
Trial end date:
2026-11-01
Target enrollment:
0
Participant gender:
All
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).
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Gilead Sciences
Treatments:
Bevacizumab
Fluorouracil
Irinotecan
Leucovorin
Magrolimab
Criteria
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 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

Key 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.