Phase 1, Two-Part, Multicenter, Non-randomized, Open-label, Multiple Dose First-In-Human Study of DS-8201A, in Subjects With Advanced Solid Malignant Tumors

Trial Profile

Phase 1, Two-Part, Multicenter, Non-randomized, Open-label, Multiple Dose First-In-Human Study of DS-8201A, in Subjects With Advanced Solid Malignant Tumors

Recruiting
Phase of Trial: Phase I

Latest Information Update: 27 Mar 2018

At a glance

  • Drugs Trastuzumab-deruxtecan (Primary)
  • Indications Adenocarcinoma; Advanced breast cancer; Gastric cancer; Oesophageal cancer; Solid tumours
  • Focus Adverse reactions; First in man; Therapeutic Use
  • Sponsors Daiichi Sankyo Company
  • Most Recent Events

    • 27 Mar 2018 According to a Daiichi Sankyo company media release, DS-8201 has received SAKIGAKE Designation for the treatment of HER2-positive advanced gastric or gastroesophageal junction cancer by the Japan Ministry of Health, Labour and Welfare (MHLW).
    • 01 Mar 2018 Planned End Date changed from 1 Mar 2018 to 1 Sep 2019.
    • 01 Mar 2018 Planned primary completion date changed from 1 Dec 2017 to 1 Dec 2018.
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