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Photoimmunotherapy (PIT) Study in Recurrent Head / Neck Cancer for Patients Who Have Failed at Least Two Lines of Therapy

Trial Status: Active

This study will evaluate the efficacy and safety of ASP-1929 Photoimmunotherapy as a monotherapy 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.

Inclusion Criteria

  • Patients must have histologically confirmed locoregional persistent, recurrent or second primary squamous cell carcinoma of the head and neck, not amenable to curative treatment. Patients must 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). Patients must not have a 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.


San Francisco
UCSF Medical Center-Mission Bay
Contact: UCSF Clinical Trials
Phone: 877-827-3222


University of Miami Miller School of Medicine-Sylvester Cancer Center
Status: ACTIVE


University of Kentucky / Markey Cancer Center
Status: ACTIVE


Wayne State University / Karmanos Cancer Institute


Thomas Jefferson University Hospital
University of Pennsylvania / Abramson Cancer Center
Status: ACTIVE


M D Anderson Cancer Center
Status: ACTIVE

The study will have an Experimental Arm and a Control Arm. Experimental Arm: Patients may receive repeated ASP-1929 PIT interventions for a period of up to 12 months after randomization until the patient has complete remission, progressive disease that is no longer amendable to study treatment, patient experiences intolerable side effects, or patient discontinues study treatment. Control Arm: Patients may be treated with physician's choice SOC until the patient has progressive disease, patient experiences intolerable side effects, or patient discontinues study treatment.

Trial Phase Phase III

Trial Type Treatment

Lead Organization
Rakuten Medical, Inc.

  • Primary ID ASP-1929-301
  • Secondary IDs NCI-2019-01324
  • ID NCT03769506