NCT03769506

ASP-1929 Photoimmunotherapy (PIT) Study in Recurrent Head/Neck Cancer for Patients Who Have Failed at Least Two Lines of Therapy

A Phase 3, Randomized, Double-Arm, Open-Label, Controlled Trial of ASP-1929 Photoimmunotherapy Versus Physician's Choice Standard of Care for the Treatment of Locoregional, Recurrent Head and Neck Squamous Cell Carcinoma in Patients Who Have Failed or Progressed On or After at Least Two Lines of Therapy, of Which at Least One Line Must Be Systemic Therapy

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 135 (actual)
• Sponsor: Rakuten Medical, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A Phase 3, Randomized, Double-Arm, Open-Label, Controlled Trial of ASP-1929 vs Physician's Choice Standard of Care for the Treatment of Locoregional, Recurrent Head and Neck Squamous Cell Carcinoma in Patients Who Have Failed or Progressed On or After at Least Two Lines of Therapy

Detailed description

The study will have an Experimental Arm and a Control Arm. Experimental Arm: Patients may receive repeated ASP-1929 PIT interventions for up to a maximum of 8 cycles within a period of up to 12 months after randomization until the patient has complete remission, progressive disease that is no longer amendable to study treatment, patient experiences intolerable side effects, patient discontinues study treatment, or chooses to withdraw. Repeat ASP-1929 treatment cycles will be administered no less than 4 weeks from the previous ASP-1929 infusion. Control Arm: Patients may be treated with physician's choice standard of care until the patient has progressive disease, patient experiences intolerable side effects, discontinues study treatment, or chooses to withdraw.

Conditions

• Head and Neck Cancer

Interventions

Type	Name	Description
COMBINATION_PRODUCT	ASP-1929 Photoimmunotherapy	Use of ASP-1929 PIT therapy
DRUG	Physician's Choice SOC	docetaxel, cetuximab, methotrexate, paclitaxel

Timeline

• Start date: 2019-05-09
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2018-12-07
• Last updated: 2025-01-16

Locations

22 sites across 4 countries: United States, India, Japan, Taiwan

Regulatory

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