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NCT06338657 · ClinicalTrials.gov registry record · Phase 1
FID-007 Followed by Standard of Care Surgery in Head and Neck Cancer
A Phase 1 study, sponsored by University of Southern California.
- Terminated
- Registry status
- Phase 1
- Development phase
- 1
- Enrollment target
NCT06338657: Clinical Trial Phase 1 study, sponsored by University of Southern California.
NCT06338657 is a Phase 1 study that was terminated before completion, run by University of Southern California. The registered enrollment target is 1 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06338657, a Phase 1 study, was terminated before completion, sponsored by University of Southern California.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 1 participants
- Enrollment target
Study Summary
This phase I trial studies on how the PEOX-based polymer encapsulated paclitaxel FID-007 (FID-007) affects the immune cells around the tumor patients with head and neck squamous cell carcinoma. The active drug in FID-007 is paclitaxel, an established chemotherapy drug that has been shown to kill cancer cells. FID-007 is a packaged form of paclitaxel using a polyethylozaxoline (PEOX) polymer which may allow the drug to reach deeper into tumors and less into normal cells by being smaller. This study is being done to help identify future treatment options and better understand how to improve outcomes of patients with head and neck cancers after surgery.
Primary Outcome
Assessment of gene expression changes before and after the treatment with FID-007 by using paired biopsy samples by single cell-ribonucleic acid sequencing techniques. More specifically, the interested genes can be grouped as these four categories: (1) key immune checkpoint genes, including PD1, CTLA4, TIM3, LAG3, TIGIT, BTLA, VISTA, CD160, IDO, SIGLEC-15; (2) Gene signatures associated with T cell exhaustion: TOX, Blimp-1, Eomes, CD38, GZMB, GZMZ; (3) Gene signatures associated with T cell acti
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- PROCEDURE Magnetic Resonance Imaging
- DRUG PEOX-based Polymer Encapsulated Paclitaxel FID-007
- PROCEDURE Tumor Resection
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2024-04-01 |
| Est. Completion | 2025-09-09 |
| Phase | Phase 1 |
Why NCT06338657 stopped before completion
NCT06338657 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT06338657 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06338657 about?
NCT06338657 is a clinical study titled "FID-007 Followed by Standard of Care Surgery in Head and Neck Cancer". This phase I trial studies on how the PEOX-based polymer encapsulated paclitaxel FID-007 (FID-007) affects the immune cells around the tumor patients with head and neck squamous cell carcinoma. The active drug in FID-007 is paclitaxel, an established chemotherapy drug that has been shown to kill can...
What is the current status of trial NCT06338657?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 1 participants. The study started on 2024-04-01. Estimated completion is 2025-09-09.
What interventions are being tested in trial NCT06338657?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Magnetic Resonance Imaging (PROCEDURE), PEOX-based Polymer Encapsulated Paclitaxel FID-007 (DRUG), Tumor Resection (PROCEDURE).
Who is sponsoring clinical trial NCT06338657?
This trial is sponsored by University of Southern California, which has 617 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06338657's enrollment target sits among peer trials
1 2001st of 2000 the lowest 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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