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Active, not recruiting Phase 3

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

NCT03769506 · tracked via the Priya Life Science USA tracker
Phase
Phase 3
Started
2019-05-09
Last updated
2025-01-16

Condition(s) studied

Head and Neck Cancer

Investigational drug(s) / intervention(s)

ASP-1929 PhotoimmunotherapyPhysician's Choice SOC

ASP-1929 Photoimmunotherapy: Use of ASP-1929 PIT therapy

Physician's Choice SOC: docetaxel, cetuximab, methotrexate, paclitaxel

Study 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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Overall Inclusion Criteria: * 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 Exclusion Criteria: * Have a history of significant (\>= Grade 3) cetuximab infusion reactions * Have been treated with prior systematic chemotherapy or targeted small molecule therapy or radiation therapy within 2 weeks of trial Day 1 or not recovered from adverse events due to a previously administered agent * Have been treated with an anticancer monoclonal antibody therapy within 4 weeks of trial Day 1 or have not recovered from adverse events due to previously administered agent * Have been treated with an investigational agent or intervention within 4 weeks of trial Day 1 or have not recovered from adverse events, due to previously administered agent or intervention * Have a present history of distant metastatic disease (M1) * Have an active undergoing treatment or have a diagnosis of an active cancer other than nonmelanoma skin cancer or HNSCC * Have a tumor in enhanced CT or MRI scan invading a major blood vessel, unless the vessel has been embolized, stented or surgically ligated to prevent potential bleeding from a blood vessel * Have impaired hepatic function * Have impaired renal function * Have uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with trial requirements * Have been previously treated or randomized to any trial using ASP-1929 or RM-1929 PIT as the study treatment

Primary outcome measure(s)

  • Progression-Free Survival (PFS) — 24 months
    PFS, defined as the time from randomization to the first occurrence of disease progression (PD), as determined by the Central Radiographic Review according to RECIST 1.1 with modifications, or death from any cause, whichever occurs first.
  • Overall Survival (OS) — 24 months
    OS, defined by the time interval between the patient randomization and death due to any cause.

Trial sites (22)

FacilityCityRegionStatus
Cancer Clinic Miami Florida
Cancer Clinic Tampa Florida
Cancer Clinic Atlanta Georgia
Cancer Clinic Lexington Kentucky
Cancer Clinic 1 Philadelphia Pennsylvania
Cancer Clinic 2 Philadelphia Pennsylvania
Cancer Clinic Houston Texas
Cancer Clinic Vadodara Gujarat
Cancer Clinic Vadodara Gujarat
Cancer Clinic Bangalore Kamataka
Cancer Clinic Kochi Kerala
Cancer Clinic Chennai Tamil Nadu
Cancer Clinic Hyderabad Telangana
Cancer Clinic Kolkata West Bengal
Cancer Clinic Mumbai India
Cancer Clinic Nagoya Aichi-ken
Cancer Clinic Sapporo Hokkaido
Cancer Clinic Okayama Okayama-ken
Cancer Clinic Chuo-ku Tokyo
Cancer Clinic Taichung Taiwan
Cancer Clinic Taipei Taiwan
Cancer Clinic Taoyuan Taiwan
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03769506 on ClinicalTrials.gov ↗ ← All trials in the USA