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A global phase III trial to evaluate the efficacy and safety of ASP-1929 in the patients with late-stage, recurrent, local regional HNSCC who have previously failed at least two lines of therapy and are not eligible for surgery or radiation.

Trial Profile

A global phase III trial to evaluate the efficacy and safety of ASP-1929 in the patients with late-stage, recurrent, local regional HNSCC who have previously failed at least two lines of therapy and are not eligible for surgery or radiation.

Recruiting
Phase of Trial: Phase III

Latest Information Update: 17 Dec 2018

At a glance

  • Drugs ASP 1929 (Primary)
  • Indications Head and neck cancer; Squamous cell cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms LUZERA-301
  • Sponsors Aspyrian Therapeutics; Rakuten Aspyrian
  • 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.
    • 17 Dec 2018 According to an Aspyrian Therapeutics media release, enrollment is underway in this trial.
    • 17 Dec 2018 Status changed from planning to recruiting, according to an Aspyrian Therapeutics media release.
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