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RecruitingLast updated: 15 August 2023

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. The second part 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 Bowel

Age

People18+

Phase

II

More information

Trial Identifiers

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Commercial 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

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

Exclusion

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

Clinical trials have complex eligibility criteria.

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