Study on ASP-1929 Photoimmunotherapy for Recurrent Head and Neck Cancer in Patients Who Have Tried at Least Two Treatments

Sponsor: Rakuten Medical, Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03769506

Provider View

This clinical trial is testing a new treatment called ASP-1929 Photoimmunotherapy (PIT) for patients with head and neck cancer that has returned or persisted after at least two previous treatments. The study compares ASP-1929 PIT with the standard care chosen by the patient's doctor.

Patient Parameters

Program Overview

The purpose of this study is to find out if ASP-1929 Photoimmunotherapy (PIT) is effective in treating head and neck cancer that has come back or continued after at least two previous treatments. The trial will compare this new treatment with the standard care chosen by the patient's doctor. Patients will be randomly assigned to either receive ASP-1929 PIT or the standard care. The study will monitor how well the treatments work and any side effects experienced by the patients.

Description

The study is divided into two groups: the Experimental Arm and the Control Arm.

In the Experimental Arm, patients will receive ASP-1929 Photoimmunotherapy (PIT) treatments. They can have up to 8 treatment cycles over 12 months, unless the cancer goes into complete remission, the disease progresses and can no longer be treated with the study therapy, the patient experiences severe side effects, or the patient decides to stop the treatment. Each treatment cycle will be at least 4 weeks apart.

In the Control Arm, patients will receive the standard care chosen by their doctor. This treatment will continue until the cancer progresses, the patient experiences severe side effects, or the patient decides to stop the treatment.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of head and neck squamous cell carcinoma that has returned or persisted and cannot be cured with standard treatments.
  • Have tried at least two previous treatments for this cancer, including one platinum-based chemotherapy.
  • Have completed previous radiation therapy aimed at curing the cancer in the head and neck area.
  • Have tumors in the head and neck that can be reached with light for treatment.
  • Have tumors that can be clearly measured using a CT or MRI scan.
  • Have a life expectancy of more than 6 months, as judged by the doctor.
  • Male participants must agree to use contraception during treatment and for at least 6 months after the last ASP-1929 treatment.
  • Female participants who can become pregnant must not be pregnant or breastfeeding and must agree to use contraception during treatment and for at least 6 months after the last treatment. They must also not breastfeed for at least 2 months after the last ASP-1929 treatment.
  • Have a performance status score of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.

Exclusion Criteria

  • Have had severe allergic reactions to cetuximab infusions.
  • Have received chemotherapy, targeted therapy, or radiation therapy within 2 weeks before starting the trial, or have not recovered from side effects of previous treatments.
  • Have received monoclonal antibody therapy within 4 weeks before starting the trial, or have not recovered from side effects of previous treatments.
  • Have participated in another clinical trial or received an investigational treatment within 4 weeks before starting the trial, or have not recovered from side effects of previous treatments.
  • Have cancer that has spread to distant parts of the body.
  • Have another active cancer, except for nonmelanoma skin cancer or head and neck squamous cell carcinoma.
  • Have a tumor that is invading a major blood vessel, unless the vessel has been treated to prevent bleeding.
  • Have liver or kidney problems.
  • Have uncontrolled health issues, such as ongoing infections, heart failure, unstable chest pain, irregular heartbeats, or mental health conditions that would make it difficult to follow the trial requirements.
  • Have previously been treated with ASP-1929 or RM-1929 PIT in any trial.

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