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.
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
- 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.