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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: 04 Nov 2025

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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

  • 24 Sep 2025 ENHERTU (6.4mg/kg) is approved in more than 70 countries worldwide for the treatment of adult patients with locally advanced or metastatic HER2-positive (IHC 3+ or 2+/ISH+) gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen based on the results from the DESTINY-Gastric01, DESTINY-Gastric02 and/or DESTINY-Gastric06 trials.
  • 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.

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