Phase 3 Randomized, Double-Arm, Open-Label, Controlled Trial of ASP-1929 Photoimmunotherapy Versus Standard of Care for Locoregional Recurrent Head/Neck Squamous Cell Carcinoma in Patients Who Have Failed After at Least Two Lines of Therapy
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.
The study will have an Experimental Arm and a Control Arm.
Patients may receive repeated ASP-1929 PIT interventions for a period of up to 12 months after randomization until one of the following outcomes is noted:
• The target and non-target tumor(s) achieve a complete remission
• The progressive disease is no longer amenable to further study interventions
• The patient experiences intolerable side effects or chooses to withdraw. Repeat intervention cycles should be administered ≥ 4 weeks from the prior ASP-1929 infusion. For recurrent or new target and non-target tumor(s), intervention cycles should be administered within 28 days of clinical, pathological, or radiological confirmation of recurrent or new target and non-target tumor(s).
Patients may be treated with physician's choice SOC until the following outcome is noted:
• Progressive Disease (PD) (SOC arm only)
• Patients with histologically confirmed locoregional persistent, recurrent or second primary squamous cell carcinoma of the head and neck, not amenable to curative treatment.
• Patient must 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 chemotherapy for treatment of their primary or recurrent head and neck cancer.
• Patients must have completed prior curative radiation therapy for treatment of their head and neck cancer.
• All locoregional head and neck tumor site(s) are accessible for light illumination treatment.
• Target tumors are clearly measurable by contrast enhanced CT scan.
• Life expectancy > 6 months.
• Patients must understand the investigational nature of the trial, be willing to sign a written informed consent, and be willing to comply with all study procedures and follow-up.
• Patients with a history of significant (≥ Grade 3) cetuximab infusion reactions.
• Patients who have been treated with prior systemic chemotherapy or targeted small molecule therapy or radiation therapy within 2 weeks of trial Day 1 or who have not recovered from adverse events due to previously administered agent.
• Patients who have been treated with an anticancer monoclonal antibody therapy within 4 weeks of trial Day 1 or who have not recovered from adverse events due to previously administered agent.
• Patients who have been treated with an investigational agent or intervention within 4 weeks of trial Day 1 or who have not recovered from adverse events, due to previously administered agent or intervention.
• Present history of distant metastatic disease (M1).
• Patients who are actively undergoing treatment of or have a diagnosis of an active cancer other than nonmelanoma skin cancer or HNSCC.
• Tumor invading a major blood vessel unless the vessel has been embolized, stented or surgically ligated to prevent potential bleeding from a blood vessel.
• Patients must have a Hemoglobin ≥ 9.0 g/dL, WBC ≥ 2000/μL, and Platelets ≥ 100 x 10³/μL.
• Patients with impaired hepatic function.
• Patients with impaired renal function.
Oral, Head and Neck
R Bryan Bell, M.D.
Rakuten Medical, Inc. (formerly Aspyrian Therapeutics, Inc. and Rakuten Aspyrian, Inc.)
- Providence Cancer Institute Franz Clinic