ASP-1929 Photoimmunotherapy (PIT) Study in Recurrent Head/Neck Cancer for Patients Who Have Failed At Least Two Lines of Therapy
Head and Neck Cancer
Skin Cancer (Non-Melanoma)
Unknown Primary
18 Years and older, Male and Female
ASP-1929-301 (primary)
NCI-2019-01324
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 up to a maximum of 8 cycles
within 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, patient discontinues study treatment, or chooses to
withdraw. Repeat ASP-1929 treatment cycles will be administered no less than 4 weeks from
the previous ASP-1929 infusion.
Control Arm:
Patients may be treated with physician's choice standard of care until the patient has
progressive disease, patient experiences intolerable side effects, discontinues study
treatment, or chooses to withdraw.
Eligibility
- Have a 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 for squamous cell carcinoma of the head and neck, one of which must be prior systemic platinum-based chemotherapy
- Have completed prior curative radiation therapy for treatment of their head and neck region
- Have locoregional head and neck tumor site(s) that are all accessible to light illumination
- Have target tumors that are clearly measurable by contrast enhanced CT scan, or MRI scan with gadolinium if CT scan is not adequate or the patient has an allergy to CT contrast media.
- Have a life expectancy of > 6 months, based on Investigator judgment
- Male participants must agree to use contraception during the treatment period and for at least 6 months after the last ASP-1929 infusion
- Female patients of childbearing potential must not be pregnant or breastfeeding and agree 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
- Have an Eastern Cooperative Oncology Group (ECOG) score of 0 or 1 Overall
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