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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: Active Phase 1 study of Metastatic Head-and-neck Squamous-cell Carcinoma and Recurrent Head and Neck Squamous Cell Carcinoma, sponsored by Rakuten Medical.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Treatment Emergent Adverse Events (TEAE) and Serious TEAE
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2020-12-21 |
| Est. Completion | 2027-06 |
| Phase | Phase 1 |
What the registry record for NCT04305795 still lists
NCT04305795 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 126-participant average among 24 other Metastatic Head-and-neck Squamous-cell Carcinoma trials with a reported enrollment target (82% lower).
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 lists 7 locations in 7 states (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.
Learn More About Clinical Trials
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Where NCT04305795's enrollment target sits among peer trials
23 23rd of 24 higher than 1 of 24 other Metastatic Head-and-neck Squamous-cell Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Head-and-neck Squamous-cell Carcinoma 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.
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