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Phase 3 Randomized, Double-Arm, Open-Label, Controlled Trial of ASP-1929 Photoimmunotherapy Versus Standard of Care for Locoregional Recurrent Head/Neck Squamous Cell Carcinoma in Patients Who Have Failed After at Least Two Lines of Therapy

Trial Profile

Phase 3 Randomized, Double-Arm, Open-Label, Controlled Trial of ASP-1929 Photoimmunotherapy Versus Standard of Care for Locoregional Recurrent Head/Neck Squamous Cell Carcinoma in Patients Who Have Failed After at Least Two Lines of Therapy

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 29 Nov 2019

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At a glance

  • Drugs Cetuximab sarotalocan (Primary) ; Cetuximab; Docetaxel; Methotrexate
  • Indications Head and neck cancer; Squamous cell cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms LUZERA-301
  • Sponsors Aspyrian Therapeutics; Rakuten Medical
  • Most Recent Events

    • 17 Dec 2019 According to a Rakuten Aspyrian media release, the study includes a pre-specified interim analysis for efficacy and if the results are significant, Rakuten Aspyrian may submit them to the U.S. Food and Drug Administration for consideration for early approval.
    • 04 Jun 2019 Trial design presented at the 55th Annual Meeting of the American Society of Clinical Oncology.
    • 15 May 2019 According to a Rakuten Aspyrian media release, study criteria and details of this study will be presented at the ASCO annual meeting (31 May - 4 June 2019).
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