ASP-1929 Photoimmunotherapy (PIT) Study in in Patients With Recurrent Head/Neck Cancer

  • STATUS
    Recruiting
  • End date
    Sep 18, 2025
  • participants needed
    22
  • sponsor
    Rakuten Medical, Inc.
Updated on 5 June 2022
cancer
measurable disease
carcinoma
squamous cell carcinoma
neck cancer

Summary

A Phase 1/2, Open-label, Single-arm, Window of opportunity Study of ASP-1929 Photoimmunotherapy with Fluorescence Imaging in Patients with Operable Primary or Recurrent Head and Neck or Cutaneous Squamous Cell Carcinoma

Description

All patients will receive a combination of ASP-1929 and Photoimmunotherapy (PIT). During illumination procedure, fluorescence of the IR700 of ASP-1929 will be imaged at a wavelength in the vicinity of 830 nm with a Shimadzu Fluorescence Imaging System camera. Patients will undergo standard of care surgery approximately 15 days after ASP-1929 PIT treatment.

Details
Condition Head and Neck Cancer, Squamous Cell Carcinoma of Head and Neck
Treatment ASP-1929 Photoimmunotherapy
Clinical Study IdentifierNCT05182866
SponsorRakuten Medical, Inc.
Last Modified on5 June 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Provide written informed consent
Male or female ≥ 18 years of age at the time of informed consent
Documentation of histologically confirmed, resectable (by standard of care surgery), primary or recurrent locoregional HNSCC or cuSCC
At least one tumor lesion accessible for PIT illumination that is ALSO amenable to imaging with the Fluorescence Imaging System camera (must be within 0.5 cm and no more than 3 cm depth to the skin or mucosal surface, with the longest diameter less than 5 cm as judged by pre-treatment imaging or examination)
Measurable disease by RECIST 1.1, as assessed by the Investigator
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at the time of screening
Adequate organ function laboratory values as described below (all screening labs should be performed ≤ 14 days of Day 1)
Female patients of childbearing potential must not be pregnant (confirmed by negative pregnancy test [urine or serum] at screening) or breastfeeding and must be willing to use a method of highly effective birth control, or practice abstinence throughout the study and for 60 days after the last dose of ASP-1929
Male patients must be sterile or agree to use an adequate method of contraception or practice abstinence throughout the study and for 60 days after the last dose of ASP-1929

Exclusion Criteria

Receiving any other investigational agents or who have received local
History of significant (≥ Grade 3) infusion reaction to anti-EGFR antibodies
History of allergic reactions attributed to compounds of similar chemical or biologic composition to ASP-1929, or other agents used in study
Require use of photosensitizing medications (refer to Table 4 for list of common photosensitizing medications)
Tumor invading major blood vessel unless the vessel has been embolized, stented, or surgically ligated to prevent hemorrhage
Requiring future examinations or treatments within 4 weeks after an ASP-1929 PIT treatment cycle exposing the patient to high-intensity light (eg, eye examinations, surgical procedures) that are unrelated to ASP-1929 PIT treatment, the disease under study, or the study overall
Diagnosed and/or treated for additional malignancy within 3 years before study Day 1, except for those with a negligible risk of metastasis or death
Known infection or detection of active Hepatitis B (eg, HBsAg positive), Hepatitis C (eg, RNA [qualitative]), or SARS-CoV-2 (qualitative)
Received a live, attenuated vaccine within 4 weeks before Day 1 or anticipation of receiving a live, attenuated vaccine will be required during the study (based on known medical history). Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (eg, Flu-Mist®) are live attenuated vaccines, and are not allowed
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 study requirements
Major surgery or significant traumatic injury within 4 weeks of study Day 1, or anticipation of the need for major surgery that is unrelated to study intervention during the study. Note: If patient has had major surgery, they must have recovered adequately from the toxicity and/or complications before study Day 1
Currently participating or participated in a study of any investigational agent or used any investigational device within 4 weeks of study Day 1
Unwilling or unable to follow protocol requirements
Any other condition which, in the Investigator's opinion, deems the patient an unsuitable candidate to receive ASP-1929 and/or be exposed to illumination, may affect the interpretation of the results, or render the patient at high risk from treatment complications
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