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A Phase 1b/2 Multicenter, Open-label, Dose-escalation and Dose-expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Antitumor Activity of Trastuzumab Deruxtecan (T-DXd) Monotherapy and Combinations in Adult Participants With HER2-expressing Gastric Cancer (DESTINY-Gastric-03)

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Trial Profile

A Phase 1b/2 Multicenter, Open-label, Dose-escalation and Dose-expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Antitumor Activity of Trastuzumab Deruxtecan (T-DXd) Monotherapy and Combinations in Adult Participants With HER2-expressing Gastric Cancer (DESTINY-Gastric-03)

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 19 Mar 2025

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At a glance

  • Drugs Durvalumab (Primary) ; Trastuzumab-deruxtecan (Primary) ; Capecitabine; Cisplatin; Fluorouracil; Oxaliplatin; Pembrolizumab; Trastuzumab
  • Indications Adenocarcinoma; Gastric cancer; Oesophageal cancer
  • Focus Adverse reactions; Therapeutic Use
  • Acronyms DESTINY-Gastric03; DG-03
  • Sponsors AstraZeneca; AstraZeneca AB

    • Most Recent Events

    • 02 Dec 2024 According to a Daiichi Sankyo Company media release, data from DESTINY-Gastric03 part 4, will be presented in a Poster Session on 7 Dec 2024, at ESMO 2024 Congress.
    • 03 Sep 2024 According to an AstraZeneca media release, at ESMO, an oral presentation of the DESTINY-Gastric03 Phase Ib/II trial will feature safety and efficacy data for the combination of ENHERTU, chemotherapy and pembrolizumab as a 1st-line treatment in HER2-positive gastric and gastroesophageal junction (GEJ) cancers.
    • 29 May 2024 Planned number of patients changed from 413 to 417.

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