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ACTIVE NOT RECRUITING Phase 1

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

NCT04305795 · View on ClinicalTrials.gov ↗

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

4 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04305795

The ClinicalTrials.gov registry entry for NCT04305795 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 23 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Rakuten Medical, which has 4 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 4 conditions, with Recurrent 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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04305795 reports 7 study locations spanning 7 distinct geographic areas — top geographies include Florida, Kentucky, Minnesota. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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: Recurrent Head and Neck Squamous Cell Carcinoma, Metastatic Head-and-neck Squamous-cell Carcinoma, Metastatic Cutaneous Squamous Cell Carcinoma, Locally Advanced Cutaneous Squamous Cell Carcinoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04305795?

This trial is sponsored by Rakuten Medical, which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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