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Purpose

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

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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. - Failed or progressed following prior platinum 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 illumination - Have target tumors that are clearly measurable by contract enhanced CT scan - 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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
ASP-1929 Photoimmunotherapy
Use of ASP-1929 Photoimmunotherapy
  • Combination Product: ASP-1929 Photoimmunotherapy
    Use of ASP-1929 PIT therapy
Active Comparator
Physician's Choice SOC
docetaxel, cetuximab, methotrexate, paclitaxel
  • Drug: Physician's Choice SOC
    docetaxel, cetuximab, methotrexate, paclitaxel

Recruiting Locations

University of South Florida
Tampa, Florida 33606
Contact:
Tien Nguyen
813-844-7745

Grady Health
Atlanta, Georgia 30322
Contact:
Frank Akuchie
404-942-8907

William Beaumont Hospital
Royal Oak, Michigan 48073
Contact:
Grace San Agustin
248-551-6679

Thomas Jefferson University - Sidney Kimmel Medical College
Philadelphia, Pennsylvania 19107
Contact:
Camilo Henao
215-982-0009

University of Pennsylvania
Philadelphia, Pennsylvania 19107
Contact:
Ethan Skinner
215-615-1611

MD Anderson Cancer Center
Houston, Texas 77030
Contact:
Bridget Reeves
713-745-1897

More Details

NCT ID
NCT03769506
Status
Recruiting
Sponsor
Rakuten Medical, Inc.

Study Contact

Bogdan Veresh, MD
858-207-3113
clinicaltrialinfo@rakuten-med.com

Detailed Description

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, or patient discontinues study treatment. 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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.