NCT06338657

FID-007 Followed by Standard of Care Surgery in Head and Neck Cancer

A Window of Opportunity Study of Taxanes in Head and Neck Cancer

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: University of Southern California · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Head and Neck Squamous Cell Carcinoma

Interventions

Type	Name	Description
PROCEDURE	Biospecimen Collection	Undergo blood sample collection
PROCEDURE	Computed Tomography	Undergo CT scan
PROCEDURE	Magnetic Resonance Imaging	Undergo MRI
DRUG	PEOX-based Polymer Encapsulated Paclitaxel FID-007	Given IV
PROCEDURE	Tumor Resection	Undergo surgical resection

Timeline

• Start date: 2024-04-01
• Primary completion: 2025-09-03
• Completion: 2025-09-09
• First posted: 2024-03-29
• Last updated: 2025-09-16

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study