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ASP-1929 Photoimmunotherapy (PIT) Study in Recurrent Head/Neck Cancer for Patients Who Have Failed at Least Two Lines of Therapy

Status
Active
Cancer Type
Head and Neck Cancer
Skin Cancer (Non-Melanoma)
Unknown Primary
Trial Phase
Phase III
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT03769506
Protocol IDs
ASP-1929-301 (primary)
NCI-2019-01324
Study Sponsor
Rakuten Medical, Inc.

Summary

A Phase 3, Randomized, Double-Arm, Open-Label, Controlled Trial of ASP-1929 vs 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

Objectives

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.

Eligibility

  1. Have a histologically confirmed locoregional persistent, recurrent or second primary squamous cell carcinoma of the head and neck, not amenable to curative treatment
  2. Have failed or progressed on or after at least 2 lines of therapy for squamous cell carcinoma of the head and neck, one of which must be prior systemic platinum-based chemotherapy
  3. Have completed prior curative radiation therapy for treatment of their head and neck region
  4. Have locoregional head and neck tumor site(s) that are all accessible to illumination
  5. Have target tumors that are clearly measurable by contract enhanced CT scan
  6. Have a life expectancy of > 6 months, based on Investigator judgment
  7. Male participants must agree to use contraception during the treatment period and for at least 6 months after the last ASP-1929 infusion
  8. Female patients of childbearing potential must not be pregnant or breastfeeding and agrees to follow the contraceptive guidance during the treatment period and for at least 6 months after the last dose of trial intervention and must refrain from breastfeeding for at least 2 months after the last ASP-1929 infusion
  9. Have an Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
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