Ignite Creation Date:
2025-12-24 @ 7:02 PM
Ignite Modification Date:
2025-12-26 @ 3:41 PM
Study NCT ID:
NCT06338657
Status:
TERMINATED
Last Update Posted:
2025-09-16
First Post:
2024-03-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
FID-007 Followed by Standard of Care Surgery in Head and Neck Cancer
Sponsor:
University of Southern California
Organization:
Study Overview
Official Title:
A Window of Opportunity Study of Taxanes in Head and Neck Cancer
Status:
TERMINATED
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slow accrual
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
PRIMARY OBJECTIVE:
I. To describe the phenotypical and functional changes of different T cell subsets within the tumor microenvironment after treatment with FID-007.
SECONDARY OBJECTIVES:
I. To describe the adverse events associated with neoadjuvant FID-007 prior to surgery for head and neck cancer.
II. To evaluate preliminary evidence of efficacy by describing the rate of major and complete pathologic response.
III. To describe the rates of locoregional recurrence and rate of distant metastasis at 2 years after surgery.
EXPLORATORY OBJECTIVE:
I. Explore association between pathologic response and phenotypical and functional changes in T cell subsets.
OUTLINE:
Patients receive FID-007 intravenously (IV) over 30 minutes once a week for 3 weeks on days 1, 8, and 15 of a single 28 day cycle in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care surgery. Patients undergo computed tomography (CT) or magnetic resonance imaging (MRI) during screening and blood sample collection throughout the study.
After completion of study treatment, patients are followed up every 3 months for 2 years.
I. To describe the phenotypical and functional changes of different T cell subsets within the tumor microenvironment after treatment with FID-007.
SECONDARY OBJECTIVES:
I. To describe the adverse events associated with neoadjuvant FID-007 prior to surgery for head and neck cancer.
II. To evaluate preliminary evidence of efficacy by describing the rate of major and complete pathologic response.
III. To describe the rates of locoregional recurrence and rate of distant metastasis at 2 years after surgery.
EXPLORATORY OBJECTIVE:
I. Explore association between pathologic response and phenotypical and functional changes in T cell subsets.
OUTLINE:
Patients receive FID-007 intravenously (IV) over 30 minutes once a week for 3 weeks on days 1, 8, and 15 of a single 28 day cycle in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care surgery. Patients undergo computed tomography (CT) or magnetic resonance imaging (MRI) during screening and blood sample collection throughout the study.
After completion of study treatment, patients are followed up every 3 months for 2 years.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2024-01367 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| 7H-23-5 | OTHER | USC / Norris Comprehensive Cancer Center | View | |
| P30CA014089 | NIH | None | https://reporter.nih.gov/quic… | View |