Clinical Trial TitleA phase 3, randomized, double-arm, open-label, controlled trial of ASP-1929 photoimmunotherapy (PIT) study in recurrent head and neck squamous cell carcinoma for patients who have failed at least two lines of therapy.
National Clinical Trial Number:NCT03769506
Clinical Trial Protocol Description:
This is a Phase 3, randomized, double-arm, open-label, controlled study of ASP-1929 photoimmunotherapy (ASP-1929 PIT) versus physician’s choice standard of care (SOC) for the treatment of locoregional, recurrent head and neck squamous cell carcinoma (HNSCC) in patients who have failed or progressed on or after two lines of therapy. The objective of this study is to evaluate the efficacy and safety of ASP-1929 PIT as a monotherapy for the treatment of locoregional, recurrent HNSCC in patients who have failed or progressed on or after 2 lines of therapy.
ASP-1929 is an investigational study drug that may eventually be used to treat patients with head and neck cancer when used in combination with an experimental device used to illuminate the targeted tumor. TASP-1929 has not been approved for sale in the United States by the U.S. Food and Drug Administration (FDA) or by any other regulatory agency.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Have histologically confirmed locoregional persistent, recurrent or second primary squamous cell carcinoma of the head and neck, not amenable to curative treatment.
- Have failed or progressed on or after at least 2 lines of therapy, one of which must be prior platinum-based chemotherapy. (Treatments such as surgery followed by chemotherapy and radiation, or surgery and radiation, or radiation, or surgery is considered one line of therapy.)
- Have no history of significant reactions to cetuximab, not actively undergoing treatment of or have a diagnosis of an active cancer other than nonmelanoma skin cancer or HNSCC.
This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.