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A Phase 2, multicenter, open-label study of DS-8201a in subjects with HER2-expressing advanced gastric or gastroesophageal junction adenocarcinoma

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Trial Profile

A Phase 2, multicenter, open-label study of DS-8201a in subjects with HER2-expressing advanced gastric or gastroesophageal junction adenocarcinoma

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 16 Aug 2024

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At a glance

  • Drugs Trastuzumab-deruxtecan (Primary) ; Irinotecan; Paclitaxel
  • Indications Adenocarcinoma; Gastric cancer; Oesophageal cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms DESTINY-Gastric01
  • Sponsors Daiichi Sankyo Company

    • Most Recent Events

    • 13 Aug 2024 Results published in a Daiichi Sankyo and AstraZeneca media release.
    • 13 Aug 2024 According to a Daiichi Sankyo and AstraZeneca media release, ENHERTU has received conditional approval in China as a monotherapy for the treatment of adult patients with locally advanced or metastatic HER2 positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received two or more prior treatment regimens. Full approval for this indication will depend on whether a randomized controlled confirmatory clinical trial can demonstrate clinical benefit in this population.
    • 01 Jul 2024 Results assessing baseline HER2-associated biomarkers in circulating tumor DNA and tissue samples, and to investigate mechanisms of resistance to T-DXd were published in the Nature Medicine.

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