Official Title

A Phase 3, Randomized, Double-Arm, Open-Label, Controlled Trial of ASP-1929 Photoimmunotherapy Versus Physician's Choice Standard of Care for the Treatment of Locoregional, Recurrent Head and Neck Squamous Cell Carcinoma in Patients Who Have Failed or Progressed On or After at Least Two Lines of Therapy, of Which at Least One Line Must Be Systemic Therapy

Summary

The ASP-1929-301 study is a phase 3, randomized, open-label, controlled trial of ASP-1929 Photoimmunotherapy (PIT) versus physician’s choice standard of care for the treatment of locoregional, recurrent head and neck squamous cell carcinoma (HNSCC) in patients who have failed or progressed on or after at least two lines of therapy, of which at least one line must be systemic therapy (of note, prior immunotherapy is allowed). ASP-1929 PIT is a combination drug and device anticancer treatment that utilizes a cetuximab monoclonal antibody conjugated to a non-toxic dye that can be excited upon nonthermal 690 nm red light illumination to induce rapid cell death. The study will have an Experimental Arm and a Control Arm. ASP-1929 PIT is the novel and possibly less toxic therapy being investigated. Patients will be randomized in a 2:1 fashion to receive either ASP-1929 PIT or physician’s choice standard of care (methotrexate, docetaxel, paclitaxel). The study drug will be injected intravenously one day prior to having the participant come to the OR where a very thin optic tubing will be placed in the cancer tumor itself. When the optic tubing is illuminated it reacts with the study drug and causes the cells with the drug to die. This procedure can be performed up to 8 separate times to achieve results if needed.

Eligibility Criteria

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