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NCT04305795 · ClinicalTrials.gov registry record · Phase 1

An Open-label Study Using ASP-1929 Photoimmunotherapy in Combination With Anti-PD1 Therapy in EGFR Expressing Advanced Solid Tumors

A Phase 1 study of Metastatic Head-and-neck Squamous-cell Carcinoma and Recurrent Head and Neck Squamous Cell Carcinoma, sponsored by Rakuten Medical.

Active
Registry status
Phase 1
Development phase
23
Enrollment target
7
Study locations

NCT04305795 is a Phase 1 study of Metastatic Head-and-neck Squamous-cell Carcinoma and Recurrent Head and Neck Squamous Cell Carcinoma that is active but no longer recruiting, run by Rakuten Medical. The registered enrollment target is 23 participants, below the 126-participant average among 24 other Metastatic Head-and-neck Squamous-cell Carcinoma trials with a reported enrollment target (82% lower). The trial reports 7 study locations across 7 states.

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The verdict

NCT04305795, a Phase 1 study of Metastatic Head-and-neck Squamous-cell Carcinoma and Recurrent Head and Neck Squamous Cell Carcinoma, is active but no longer recruiting, sponsored by Rakuten Medical.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
23 participants
Enrollment target
7
Study locations

Study Summary

Open-label study using ASP-1929 photoimmunotherapy in combination with anti-PD1 therapy in patients with recurrent or metastatic head and neck and squamous cell cancer or advanced or metastatic cutaneous squamous cell carcinoma.

Interventions

  • BIOLOGICAL 200 mg Pembrolizumab
  • BIOLOGICAL 350 mg Cemiplimab
  • COMBINATION_PRODUCT ASP-1929 PIT

Study Locations (7)

Florida

  • University of Miami Hospital and Clinics - Miami

Kentucky

  • University of Kentucky - Lexington

Minnesota

  • Mayo Clinic - Rochester

Oregon

  • Providence Medical Center - Portland

Pennsylvania

  • Thomas Jefferson University - Philadelphia

Tennessee

  • Vanderbilt-Ingram Cancer Center - Nashville

Texas

  • University of Texas, MD Anderson Cancer Center - Houston

Trial Details

FieldValue
Enrollment Target 23 participants
Start Date 2020-12-21
Est. Completion 2027-06
Phase Phase 1

Sponsor

Rakuten Medical

5 total trials

What the Registry Record Tells You About NCT04305795

The ClinicalTrials.gov registry entry for NCT04305795 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 23 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 126-participant average among 24 other Metastatic Head-and-neck Squamous-cell Carcinoma trials with a reported enrollment target (82% lower). The listed sponsor is Rakuten Medical, which has 5 total studies on file at ClinicalTrials.gov.

The record links to 4 conditions, with Metastatic Head-and-neck Squamous-cell Carcinoma appearing as the primary indexed condition, and to 3 interventions - of which 200 mg Pembrolizumab is the first listed.

NCT04305795 reports 7 study locations spanning 7 distinct geographic areas - top geographies include Florida, Kentucky, Minnesota.

Frequently Asked Questions

What is clinical trial NCT04305795 about?

NCT04305795 is a clinical study titled "An Open-label Study Using ASP-1929 Photoimmunotherapy in Combination With Anti-PD1 Therapy in EGFR Expressing Advanced Solid Tumors". Open-label study using ASP-1929 photoimmunotherapy in combination with anti-PD1 therapy in patients with recurrent or metastatic head and neck and squamous cell cancer or advanced or metastatic cutaneous squamous cell carcinoma.

What is the current status of trial NCT04305795?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 23 participants. The study started on 2020-12-21. Estimated completion is 2027-06.

What conditions does trial NCT04305795 study?

This clinical trial studies the following conditions: Metastatic Head-and-neck Squamous-cell Carcinoma, Recurrent Head and Neck Squamous Cell Carcinoma, Metastatic Cutaneous Squamous Cell Carcinoma, Locally Advanced Cutaneous Squamous Cell Carcinoma.

What interventions are being tested in trial NCT04305795?

The interventions under investigation include: 200 mg Pembrolizumab (BIOLOGICAL), 350 mg Cemiplimab (BIOLOGICAL), ASP-1929 PIT (COMBINATION_PRODUCT).

Who is sponsoring clinical trial NCT04305795?

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

Where is trial NCT04305795 being conducted?

This trial has 7 study locations across Florida, Kentucky, Minnesota, Oregon, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.