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A Phase 2, Multicenter, Randomized, Study of Trastuzumab Deruxtecan in Participants With HER2-overexpressing Locally Advanced, Unresectable or Metastatic Colorectal Cancer (DESTINY-CRC02)

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Trial Profile

A Phase 2, Multicenter, Randomized, Study of Trastuzumab Deruxtecan in Participants With HER2-overexpressing Locally Advanced, Unresectable or Metastatic Colorectal Cancer (DESTINY-CRC02)

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 20 Jan 2026

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At a glance

  • Drugs Trastuzumab-deruxtecan (Primary)
  • Indications Adenocarcinoma; Colorectal cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms DESTINY-CRC02
  • Sponsors Daiichi Sankyo Inc

Most Recent Events

  • 24 Sep 2025 ENHERTU (5.4 mg/kg) is approved in more than 10 countries worldwide for the treatment of adult patients with unresectable or metastatic HER2 positive (IHC 3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options based on efficacy results from the DESTINY-PanTumor02, DESTINY-Lung01 and DESTINY-CRC02 trials.
  • 11 Sep 2025 According to Daiichi Sankyo Media release, the European Medicines Agency (EMA) has validated the Type II Variation marketing authorization application for ENHERTU (trastuzumab deruxtecan) for the treatment of adult patients with HER2 positive (immunohistochemistry [IHC] 3+) unresectable or metastatic solid tumors who have received prior treatment and have no satisfactory alternative treatment options.
  • 30 Apr 2025 Results assessing exploratory biomarker analysis (N=122 pts) were presented at the 116th Annual Meeting of the American Association for Cancer Research.

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