NCT05182866

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

Phase 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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Rakuten Medical, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A Phase 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

Detailed description

All patients will receive a combination of ASP-1929 and Photoimmunotherapy (PIT). During illumination procedure, fluorescence of the IR700 component 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 21 days after ASP-1929 PIT treatment.

Conditions

• Head and Neck Cancer
• Squamous Cell Carcinoma of Head and Neck

Interventions

Type	Name	Description
COMBINATION_PRODUCT	ASP-1929 Photoimmunotherapy	ASP-1929 640 mg/m\^2 IV infusion followed approximately 24 hours later by photoimmunotherapy

Timeline

• Start date: 2022-01-21
• Primary completion: 2024-07-11
• Completion: 2026-06-30
• First posted: 2022-01-10
• Last updated: 2024-08-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study