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A registrational Phase 3 study of sirexatamab plus bevacizumab and chemotherapy in second-line microsatellite stable Colorectal cancer (MSS CRC) patients

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Trial Profile

A registrational Phase 3 study of sirexatamab plus bevacizumab and chemotherapy in second-line microsatellite stable Colorectal cancer (MSS CRC) patients

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 21 Aug 2026

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At a glance

  • Drugs Bevacizumab (Primary) ; Fluorouracil (Primary) ; Folinic acid (Primary) ; Irinotecan (Primary) ; Oxaliplatin (Primary) ; Sirexatamab (Primary)
  • Indications Colorectal cancer
  • Focus Registrational; Therapeutic Use

Most Recent Events

  • 12 Aug 2026 According to a Cypherpunk Technologies media release, its subsidiary Leap therapeutics presented proposed Phase III trial design, and the FDA provided feedback supporting key elements of that design, including the use of a DKK1 biomarker-selected patient population and a dual-endpoint structure intended to support both accelerated and full approval.
  • 12 Aug 2026 According to a Leap Therapeutics media release, data support the utility of baseline plasma DKK1 as a liquid biomarker for improving response rates and survival with sirexatamab, making a compelling case for a biomarker-selected Phase 3 registrational trial.
  • 12 Nov 2025 According to Leap Therapeutics media release, the company expects to provide an update on the next steps in sirexatamab development and on the registrational pathway in the first quarter of 2026.

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