For Healthcare Professionals

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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About the study

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
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

  1. Have a histologically confirmed locoregional persistent, recurrent or second primary squamous cell carcinoma of the head and neck, not amenable to curative treatment
  2. Have failed or progressed on or after at least 2 lines of therapy for squamous cell carcinoma of the head and neck.
  3. Failed or progressed following prior platinum chemotherapy
  4. Have completed prior curative radiation therapy for treatment of their head and neck region
  5. Have locoregional head and neck tumor site(s) that are all accessible to illumination
  6. Have target tumors that are clearly measurable by contract enhanced CT scan
  7. Have a life expectancy of > 6 months, based on Investigator judgment
  8. Male participants must agree to use contraception during the treatment period and for at least 6 months after the last ASP-1929 infusion
  9. 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
  10. Have an Eastern Cooperative Oncology Group (ECOG) score of 0 or 1 Overall

EXCLUSION CRITERIA

  1. Have a history of significant (>= Grade 3) cetuximab infusion reactions
  2. 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
  3. 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
  4. 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
  5. Have a present history of distant metastatic disease (M1)
  6. Have an active undergoing treatment or have a diagnosis of an active cancer other than nonmelanoma skin cancer or HNSCC
  7. 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
  8. Have impaired hepatic function
  9. Have impaired renal function
  10. 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
  11. Have been previously treated or randomized to any trial using ASP-1929 or RM-1929 PIT as the study treatment
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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.
Phone iconCall 858-207-3113Email iconEmail Study Center

Study’s details


Contition

Head and Neck Cancer

Age

18+

Phase

Phase 3

Participants needed

275

Est. Completion Date

Dec 2024

Treatment type

Interventional


Sponsor

Rakuten Medical, Inc.

ClinicalTrials.gov identifier

NCT03769506

Study number

ASP-1929-301

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