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A Phase 3 Multicenter, Randomized, Open-label Study of ASP-1929 Photoimmunotherapy in Combination with Pembrolizumab Versus Standard of Care in the First-line Treatment of Patients with Locoregional Recurrence of Squamous Cell Carcinoma of the Head and Neck (HNSCC) with No Distant Metastases

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Trial Profile

A Phase 3 Multicenter, Randomized, Open-label Study of ASP-1929 Photoimmunotherapy in Combination with Pembrolizumab Versus Standard of Care in the First-line Treatment of Patients with Locoregional Recurrence of Squamous Cell Carcinoma of the Head and Neck (HNSCC) with No Distant Metastases

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 09 Jan 2026

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At a glance

  • Drugs Cetuximab sarotalocan (Primary) ; Pembrolizumab (Primary) ; Carboplatin; Cisplatin; Docetaxel; Fluorouracil; Paclitaxel
  • Indications Head and neck cancer; Squamous cell cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms ECLIPSE
  • Sponsors Rakuten Medical

Most Recent Events

  • 06 Jan 2026 According to a Rakuten Medical media release, company proceeds to drive global Phase 3 trial for ASP-1929, targeting BLA submission to the U.S. FDA in 2028.
  • 28 Jul 2025 According to a Rakuten Medical media release, this global Phase 3 trial builds upon encouraging data from an interim evaluation (data cut-off: August 31, 2023) of 19 patients enrolled in the HNSCC cohort of a Phase 1b/2 study.
  • 28 Jul 2025 According to a Rakuten Medical media release, at present, more than 15 clinical sites across the United States, Taiwan, and Japan are actively recruiting patients, with additional sites expected to be activated in these regions. To further accelerate recruitment, the company also plans to extend the study to Eastern Europe, with new sites in Ukraine and Poland anticipated to open in the near future.

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