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NCT07455032 · ClinicalTrials.gov registry record · Phase 1
Neoadjuvant CADI-05 in Combination With Pembrolizumab for Surgically Resectable Locally Advanced Head and Neck Squamous Cell Carcinomas
A Phase 1 study, sponsored by Fox Chase Cancer Center.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 22
- Enrollment target
NCT07455032 is a Phase 1 study that is actively recruiting participants, run by Fox Chase Cancer Center. The registered enrollment target is 22 participants.
The verdict
NCT07455032, a Phase 1 study, is actively recruiting participants, sponsored by Fox Chase Cancer Center.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 22 participants
- Enrollment target
Study Summary
The goal of this clinical trial is to learn if drug CADI-05, when used together with pembrolizumab (an FDA approved immunotherapy), can help treat locally advanced head and neck squamous cell carcinoma (LA-HNSCC) in adults. It will also learn about the safety of drug CADI-05. The main questions it aims to answer are: * Does using CADI-05 together with pembrolizumab help the immune system fight cancer better and lead to better results for patients? * What side effects or health problems might happen when people receive these two treatments? Participants will: * Get pembrolizumab by IV (through a vein) once on day 1 of week 1 and again day 1 of week 4. This is standard of care treatment. * Get CADI-05 as a small injection into the skin once a week for 5 weeks. This is the experimental (research) treatment. * Visit the clinic every week for treatments, checkups and tests for 5 weeks. * Have surgery between week 6 and week 7. * Return to the clinic once for a follow-up visit about 30 days after surgery.
Interventions
- BIOLOGICAL Pembrolizumab
- BIOLOGICAL intradermal injection of CADI-05
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2026-04-08 |
| Est. Completion | 2028-01-31 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07455032
The ClinicalTrials.gov registry entry for NCT07455032 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 22 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Fox Chase Cancer Center, which has 183 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT07455032 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07455032 about?
NCT07455032 is a clinical study titled "Neoadjuvant CADI-05 in Combination With Pembrolizumab for Surgically Resectable Locally Advanced Head and Neck Squamous Cell Carcinomas". The goal of this clinical trial is to learn if drug CADI-05, when used together with pembrolizumab (an FDA approved immunotherapy), can help treat locally advanced head and neck squamous cell carcinoma (LA-HNSCC) in adults. It will also learn about the safety of drug CADI-05. The main questions it a...
What is the current status of trial NCT07455032?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 22 participants. The study started on 2026-04-08. Estimated completion is 2028-01-31.
What interventions are being tested in trial NCT07455032?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), intradermal injection of CADI-05 (BIOLOGICAL).
Who is sponsoring clinical trial NCT07455032?
This trial is sponsored by Fox Chase Cancer Center, which has 183 total clinical trials registered on ClinicalTrials.gov.
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