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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: Recruiting Phase 1 study, sponsored by Fox Chase Cancer Center.

NCT07455032 is a Phase 1 study that is actively recruiting participants, run by Fox Chase Cancer Center. The registered enrollment target is 22 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (63% lower). According to ClinicalTrials.gov, the official US trial registry.

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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

FieldValue
Enrollment Target 22 participants
Start Date 2026-04-08
Est. Completion 2028-01-31
Phase Phase 1
Fox Chase Cancer Center

183 total trials

What NCT07455032 shows while recruiting

NCT07455032 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (63% lower).

The record links to 0 conditions, and to 2 interventions - of which Pembrolizumab is the first listed.

NCT07455032 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT07455032's enrollment target sits among peer trials

22 1601st of 2000 higher than 386 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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 NCT07455032, the US trial registry maintained by the National Library of Medicine. NCT07455032 (small enrollment · none site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.