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

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ClinicalTrials.gov Identifier: NCT03769506
Recruitment Status : Recruiting
First Posted : December 7, 2018
Last Update Posted : April 1, 2021
Sponsor:
Information provided by (Responsible Party):
Rakuten Medical, Inc.

Study Description
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Brief 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

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Combination Product: ASP-1929 Photoimmunotherapy Drug: Physician's Choice SOC Phase 3

Detailed Description:

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 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.

Control Arm:

Patients may be treated with physician's choice SOC until the patient has progressive disease, patient experiences intolerable side effects, or patient discontinues study treatment.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 275 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Double-Arm, Open-Label, Controlled Trial of ASP-1929 Photoimmunotherapy Versus 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, of Which at Least One Line Must Be Systemic Therapy
Actual Study Start Date : May 9, 2019
Estimated Primary Completion Date : September 30, 2024
Estimated Study Completion Date : December 30, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: ASP-1929 Photoimmunotherapy
Use of ASP1929 PIT therapy
 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, or paclitaxel


Outcome Measures
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Primary Outcome Measures :
  1. Progression-Free Survival [ Time Frame: 24 months ]
    Time to progression of disease

  2. Overall survival [ Time Frame: 24 months ]
    Duration of survival between the two treatment arms


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 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 agrees 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 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03769506


Contacts
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Contact: Sumera Raoof, MD, MPH +1 858-925-5619 clinicaltrialinfo@rakuten-med.com

Locations
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Sponsors and Collaborators
Rakuten Medical, Inc.
Investigators
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Study Director: Sarah Arron, MD Rakuten Medical, Inc.
More Information
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Publications of Results:

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Responsible Party: Rakuten Medical, Inc.
ClinicalTrials.gov Identifier: NCT03769506    
Other Study ID Numbers: ASP-1929-301
First Posted: December 7, 2018    Key Record Dates
Last Update Posted: April 1, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Rakuten Medical, Inc.:
Rakuten Medical
ASP-1929
PIT
Photoimmunotherapy
 HNC
HNSCC
Head and neck
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms by Site
Neoplasms