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

NCT06338657 | Terminated Phase 1 DMC FDA Drug

• 3 other identifiers: 7H-23-5NCI-2024-01367P30CA014089
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 2

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.

Conditions

Head and Neck Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• Evaluate the phenotypical and functional changes of different T cell subsets within the tumor microenvironment after treatment with FID-007

  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 activation: CD3, CD28, NFAT, ZAP-70, CCR5, CCR7, and CXCR3, TCF-1; and (4) Gene signatures associated with T cell memory: CD45RO, CD62L, CCR7, IL-7R, BCL6, CD44, CXCR3.

  Baseline up to 30 days

Secondary Outcomes (5)

• Incidence of adverse events (AEs)

  Baseline up to 30 days

• Major pathologic response rate

  Up to 30 days

• Complete pathologic response rate

  Up to 30 days

• Rate of locoregional recurrence

  Within 2 years of surgery (surgery will occur approximately 3-6 weeks after last dose of FID-007)

• Rate of distant metastasis

  Within 2 years of surgery (surgery will occur approximately 3-6 weeks after last dose of FID-007)

Study Arms (1)

Treatment (FID-007)

EXPERIMENTAL

Patients receive FID-007 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 CT or MRI during screening and blood sample collection throughout the study.

Procedure: Biospecimen Collection; Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging; Drug: PEOX-based Polymer Encapsulated Paclitaxel FID-007; Procedure: Tumor Resection

Interventions

Biospecimen Collection PROCEDURE

Undergo blood sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Treatment (FID-007)

Computed Tomography PROCEDURE

Undergo CT scan

Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, tomography

Treatment (FID-007)

Magnetic Resonance Imaging PROCEDURE

Undergo MRI

Also known as: Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, MRIs, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging, sMRI, Structural MRI

Treatment (FID-007)

PEOX-based Polymer Encapsulated Paclitaxel FID-007 DRUG

Given IV

Also known as: FID 007, FID-007, FID007, Nanoencapsulated Paclitaxel FID-007, Paclitaxel in Polyethyloxazoline Polymer

Treatment (FID-007)

Tumor Resection PROCEDURE

Undergo surgical resection

Treatment (FID-007)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have histopathologically / cytologically confirmed diagnosis of head and neck squamous cell carcinoma
• Sites of primary tumor allowed include the oral cavity and oropharynx only. Patients with recurrent disease that is amenable to surgery are eligible
• Patients may have any stage cancer amenable to surgical resection
• Patients must be able to provide an archival tissue specimen. Excisional biopsy or core needle biopsy specimens are allowed. Fine needle aspiration samples are not acceptable
• Patients with oropharynx cancer must have p16 negative disease
• Age ≥ 18 years
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• Leukocytes ≥ 3,000/mcL
• Absolute neutrophil count ≥ 1,500/mcL
• Platelets ≥ 100,000/mcl
• Hemoglobin ≥ 9 g/dl
• Total bilirubin ≤ 1.5 X institutional upper limit of normal
• Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \[SGOT\])/ Alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]) ≤ 2.5 X institutional upper limit of normal
• Creatinine ≤ 1.5 X institutional upper limit of normal
• Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.

You may not qualify if:

• Patients with primary sites of the nasopharynx, salivary gland, or skin
• Patients that have been previously treated with taxane chemotherapies
• Patients that have previously received radiation to the site of planned surgery
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to FID-007 or other agents used in study
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Patients must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants
• Any diagnosis of immunodeficiency or patients receiving immunosuppressive therapy within 14 days of enrollment. Prednisone dose of ≤ 10mg is allowed

Sponsors & Collaborators

• University of Southern California: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Los Angeles General Medical Center

Los Angeles, California, 90033, United States

Location

USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

Specimen Handling; Magnetic Resonance Spectroscopy; Paclitaxel; Transurethral Resection of Bladder

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Spectrum Analysis; Chemistry Techniques, Analytical; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Urologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Jacob Thomas, MD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2024
• First Posted: March 29, 2024
• Study Start: April 1, 2024
• Primary Completion: September 3, 2025
• Study Completion: September 9, 2025
• Last Updated: September 16, 2025

Record last verified: 2025-09

Locations

US (2)