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RecruitingLast updated: 26 April 2024

This phase II study is seeking to determine how safe and tolerable, and what the best dose level is, of targeted therapy (magrolimab) in addition to further targeted therapy (bevacizumab) plus combination chemotherapy (FOLFIRI) in people with advanced, metastatic bowel cancer who have had previous treatmentA 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)

Clinical summary

Summary

This study has two parts.

Part 1 (safety run-in) is evaluating how safe and tolerable, and determine the recommended Phase 2 dose (RP2D), of magrolimab + FOLFIRI. Participants in this cohort will receive magrolimab in de-escalating doses to establish the RP2D, in combination with bevacizumab (5mg/kg every 2 weeks) + FOLFIRI (irinotecan 180mg/m^2 + leucovorin 400mg/m^2 + fluorouracil 400mg/m^2 bolus followed by 2400mg/m^2 continuous on Days 1, 2, 15 and 16 of a 28-day cycle).

Part 2 (randomised cohort) is further evaluating the effectiveness of this treatment, and has an Experimental Arm and an Active Comparator Arm.

In the Experimental Arm, participants will receive the RP2D determined in the safety run-in cohort of magrolimab in combination with bevacizumab (5 mg/kg every 2 weeks) + FOLFIRI (irinotecan 180 mg/m^2 + leucovorin 400 mg/m^2 + fluorouracil 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous on Days 1, 2, 15, and 16 of a 28-Day Cycle). Additional dose expansion cohorts of magrolimab in combination with bevacizumab and FOLFIRI may be opened at the sponsor's discretion.

In the Active Comparator Arm, participants will receive bevacizumab (5 mg/kg every 2 weeks) + FOLFIRI (irinotecan 180 mg/m^2 +leucovorin 400 mg/m^2 + fluorouracil 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous on Days 1, 2, 15, and 16 of a 28-Day Cycle). All treatments will be administered intravenously.

Conditions

This trial is treating patients with cancer of the bowel, colon or rectum

Cancer

Bowel Cancers Lower gastrointestinal tract

Age

People18+

Phase

II

More information

Trial Identifiers

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Trial sponsor

Gilead Sciences, Inc.

Scientific 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

Inclusion

  • 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.

Exclusion

  • 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.

Inclusion

  • Your cancer has spread to other parts of the body.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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