Study on ASP-1929 Photoimmunotherapy for Patients with Recurrent Head and Neck Cancer

Sponsor: Rakuten Medical, Inc.

Sponsor score: 0

ClinicalTrials ID:NCT05182866

Provider View

This clinical trial is testing a new treatment called ASP-1929 Photoimmunotherapy (PIT) for patients with head and neck cancer that has come back or is operable. The study aims to see if this treatment can be safely used before surgery.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the safety and effectiveness of ASP-1929 Photoimmunotherapy (PIT) in patients with head and neck cancer that can be surgically removed. The treatment involves using a special light to activate the drug ASP-1929, which is designed to target cancer cells. Patients will receive this treatment and then undergo surgery about 21 days later.

Description

In this study, all participants will receive a combination of the drug ASP-1929 and a treatment called Photoimmunotherapy (PIT). During the treatment, a special camera will be used to capture images of the drug's fluorescence, which helps in targeting the cancer cells. After receiving the ASP-1929 PIT treatment, patients will have surgery to remove the cancer approximately 21 days later.

Eligibility Criteria

Inclusion Criteria

  • Must provide written consent to participate.
  • Must be 18 years or older.
  • Must have a confirmed diagnosis of head and neck cancer that can be surgically removed.
  • Tumor must be located in specific areas such as the oropharynx, oral cavity, sinonasal tract, hypopharynx, or larynx.
  • Must have at least one tumor that can be treated with ASP-1929 PIT and is visible with the imaging system.
  • Must be in good general health with an ECOG performance status of 0 or 1.
  • Must have adequate organ function based on lab tests.
  • Women of childbearing potential must not be pregnant and must agree to use effective birth control during the study and for 60 days after the last dose.
  • Men must agree to use contraception or be sterile during the study and for 60 days after the last dose.
  • Must provide a fresh tumor biopsy or a recent sample if a fresh one cannot be obtained.

Exclusion Criteria

  • Currently receiving other investigational treatments or have had cancer treatments within 4 weeks before starting ASP-1929 PIT.
  • History of severe allergic reactions to similar treatments.
  • Need to use medications that make the skin sensitive to light.
  • Tumors that are not suitable for ASP-1929 PIT, such as those in the brain or with certain blood vessel involvement.
  • History of cancer that has spread to distant parts of the body.
  • Any conditions that prevent safe use of CT or PET/CT imaging.
  • Weigh more than 350 pounds or cannot fit in the imaging machine.
  • Need for procedures involving high-intensity light exposure within 4 weeks after treatment.
  • Diagnosed with another cancer within the last 3 years, except for certain low-risk cancers.
  • Positive for HIV, active Hepatitis B or C, or COVID-19.
  • Received a live vaccine within 4 weeks before starting the study.
  • Have uncontrolled illnesses or conditions that would interfere with the study.
  • Had major surgery or injury within 4 weeks before starting the study.
  • Participating in another clinical trial within 4 weeks before starting the study.
  • Unable or unwilling to follow study requirements.
  • Any other condition that makes participation unsafe or affects study results.

Locations

FACILITYZIPCITYSTATE
Center for Cancer Research20892BethesdaMaryland

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