An Uncontrolled, Open-label, Multicenter Safety Confirmation Study of 5 or More Cycles of Photoimmunotherapy

JRCT ID: jRCT2041230050

Registered date:25/06/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Head and Neck Cancer
• Date of first enrollment: 25/06/2023
• Target sample size: 35
• Study type: Interventional
• Intervention(s): Medication and Surgery

Outcome(s)

• Primary Outcome: Frequency of onset of Grade 3 or higher AEs for which causal relationship cannot be ruled out

Secondary Outcome

- Frequency of onset of AEs, Grade 3 or higher AEs, AEs leading to treatment discontinuation, SAEs, and AEs leading to death, etc.
- Frequency of onset of adverse device effects (ADEs), Grade 3 or higher ADE, ADE leading to treatment discontinuation, serious adverse device effects (SADEs), and ADE leading to death, etc.
- Using modified RECIST 1.1, changes over time in the diameter of target lesions illuminated with the laser light, percent ch
anges, maximum percent changes in the sum of diameters of target lesions from baseline, and disease control rate, etc.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Patients with unresectable, locally advanced, or locally recurrent head and neck cancer
2. Patients who failed to respond to standard therapies such as chemoradiotherapy or for whom no appropriate therapy is available
3. Patients who had completed the fourth cycle of photoimmunotherapy with Akalux after its market launch and require the fifth cycle
4. Patients with at least one lesion of head and neck cancer that can be illuminated
5. Patients aged 18 years or older at the time of enrollment
6. Patients

Exclude criteria

1. Patients with Grade 3 or higher AEs that fail to recover to Grade 2 or lower after the fourth cycle of Akalux photoimmunotherapy (PIT) If the principal investigator (sub-investigator) of the post-marketing clinical study judges that the toxicity is acceptable, the appropriateness of enrollment may be judged after discussion with the medical monitor at the sponsor of the post-marketing clinical study.
2. Patients with ECOG PS >=3
3. Patients who received other treatments for the underlying disease after the fourth cycle of Akalux PIT
4. Patients with unequivocal disease progression after the fourth cycle of Akalux PIT
5. Patients whose lesions after the fourth cycle of Akalux PIT are CR and who need PIT for lesions other than those at the laser illuminated site
6. Patients with a history of hypersensitivity to any of the ingredients of ASP-1929
7. Patients with tumor involvement of the carotid artery
8. Female patients with positive pregnancy tests
Female patients require pregnancy testing if they have had their first menstrual period, had not undergone a hysterectomy, bilateral salpingectomy, bilateral oophorectomy, and have not had their periods for at least 12 months without an alternative medical cause.
9. Nursing mothers and females who may (or intend to) become pregnant during the study period
10. Males unwilling to use contraception
11. Any condition which in the investigator opinion deems the patient an unsuitable candidate to receive study treatment

Related Information

• Primary Sponsor: Nagamatsu Kazuo