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

NCT03769506 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 135

Last updated 2025-01-16

No results posted yet for this study

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

Conditions

Interventions

COMBINATION_PRODUCT

ASP-1929 Photoimmunotherapy

Use of ASP-1929 PIT therapy

DRUG

Physician's Choice SOC

docetaxel, cetuximab, methotrexate, paclitaxel

Sponsors & Collaborators

  • Rakuten Medical, Inc.

    lead INDUSTRY

Principal Investigators

  • Ethan Chen, MD · Rakuten Medical

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-09
Primary Completion
2025-12-31
Completion
2025-12-31
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States
  • India
  • Japan
  • Taiwan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03769506 on ClinicalTrials.gov