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

Status: Active

Description

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.

Eligibility Criteria

Inclusion Criteria

  • Inclusion Criteria including but not limited to: - 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. - Male patients at least 18 years old. - Female patients at least 18 years old. - Patients must have an ECOG score of 0 - 1. - 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. Exclusion Criteria including but not limited to: - 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.

Locations & Contacts

Florida

Miami
University of Miami Miller School of Medicine-Sylvester Cancer Center
Status: Active
Name Not Available

Michigan

Detroit
Wayne State University / Karmanos Cancer Institute
Status: Temporarily closed to accrual
Name Not Available

Pennsylvania

Philadelphia
Thomas Jefferson University Hospital
Status: Active
Name Not Available
University of Pennsylvania / Abramson Cancer Center
Status: Active
Name Not Available

Texas

Houston
M D Anderson Cancer Center
Status: Approved
Name Not Available

Trial Objectives and Outline

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 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). Control Arm: Patients may be treated with physician's choice SOC until the following outcome is noted: • Progressive Disease (PD) (SOC arm only)

Trial Phase & Type

Trial Phase

Phase III

Trial Type

Treatment

Lead Organization

Lead Organization
Rakuten Medical, Inc.

Trial IDs

Primary ID ASP-1929-301
Secondary IDs NCI-2019-01324
Clinicaltrials.gov ID NCT03769506