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NCT03769506 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Head and Neck Cancer, sponsored by Rakuten Medical.

Active
Registry status
Phase 3
Development phase
135
Enrollment target
20
Study locations

NCT03769506: Active Phase 3 study of Head and Neck Cancer, sponsored by Rakuten Medical.

NCT03769506 is a Phase 3 study of Head and Neck Cancer that is active but no longer recruiting, run by Rakuten Medical. The registered enrollment target is 135 participants, below the 260-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (48% lower). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03769506, a Phase 3 study of Head and Neck Cancer, is active but no longer recruiting, sponsored by Rakuten Medical.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
135 participants
Enrollment target
20
Study locations

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

Primary Outcome

PFS, defined as the time from randomization to the first occurrence of disease progression (PD), as determined by the Central Radiographic Review according to RECIST 1.1 with modifications, or death from any cause, whichever occurs first.

Conditions Studied

Interventions

  • COMBINATION_PRODUCT ASP-1929 Photoimmunotherapy
  • DRUG Physician's Choice SOC

Study Locations (20)

Florida

  • Cancer Clinic - Miami
  • Cancer Clinic - Tampa

Pennsylvania

  • Cancer Clinic 1 - Philadelphia
  • Cancer Clinic 2 - Philadelphia

Gujarat

  • Cancer Clinic - Vadodara
  • Cancer Clinic - Vadodara

Other

  • Cancer Clinic - Mumbai
  • Cancer Clinic - Taichung

Georgia

  • Cancer Clinic - Atlanta

Kentucky

  • Cancer Clinic - Lexington

Texas

  • Cancer Clinic - Houston

Kamataka

  • Cancer Clinic - Bangalore

Trial Details

FieldValue
Enrollment Target 135 participants
Start Date 2019-05-09
Est. Completion 2025-12
Phase Phase 3
Rakuten Medical

5 total trials

What the registry record for NCT03769506 still lists

NCT03769506 is an interventional study that assigns participants to a tested intervention. The registered 135 participants enrollment target is mid-sized for trials with a published cap, below the 260-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (48% lower).

The record links to 1 condition, with Head and Neck Cancer appearing as the primary indexed condition, and to 2 interventions - of which ASP-1929 Photoimmunotherapy is the first listed.

NCT03769506 names 20 study sites across 16 states, led by Florida, Pennsylvania, Gujarat.

Frequently Asked Questions

What is clinical trial NCT03769506 about?

NCT03769506 is a clinical study titled "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 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

What is the current status of trial NCT03769506?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 135 participants. The study started on 2019-05-09. Estimated completion is 2025-12.

What conditions does trial NCT03769506 study?

This clinical trial studies the following conditions: Head and Neck Cancer.

What interventions are being tested in trial NCT03769506?

The interventions under investigation include: ASP-1929 Photoimmunotherapy (COMBINATION_PRODUCT), Physician's Choice SOC (DRUG).

Who is sponsoring clinical trial NCT03769506?

This trial is sponsored by Rakuten Medical, which has 5 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03769506 being conducted?

This trial has 20 study locations across Florida, Georgia, Kentucky, Pennsylvania, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Head and Neck Cancer

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT03769506's enrollment target sits among peer trials

135 68th of 250 higher than 183 of 250 other Head and Neck Cancer trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Head and Neck Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03769506, the US trial registry maintained by the National Library of Medicine. NCT03769506 (mid enrollment · wide site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.