Head and Neck Squamous Cell CarcinomaPhase 1NCT06338657
FID-007 Followed by Standard of Care Surgery in Head and Neck Cancer
A Phase 1 study testing Biospecimen Collection, Computed Tomography and Magnetic Resonance Imaging in people with Head and Neck Squamous Cell Carcinoma, run by University of Southern California at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Squamous Cell Carcinoma
- What is being tested?
- Biospecimen Collection, Computed Tomography and Magnetic Resonance Imaging
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Apr 2024to 9 Sep 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 19Show fewer
- 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.
- A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
- Has not undergone a hysterectomy or bilateral oophorectomy; or
- Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)
- Ability to understand and the willingness to sign a written informed consent
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Los Angeles General Medical Center
Los Angeles, California, 90033
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033
About this study
Official title: A Window of Opportunity Study of Taxanes 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 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.
Read the detailed description
PRIMARY OBJECTIVE:
- To describe the phenotypical and functional changes of different T cell subsets within the tumor microenvironment after treatment with FID-007.
SECONDARY OBJECTIVES:
- 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:
- 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
- Being tested
- Biospecimen Collection, Computed Tomography, Magnetic Resonance Imaging, PEOX-based Polymer Encapsulated Paclitaxel FID-007, Tumor Resection
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo blood sample collection
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography
Undergo CT scan
Magnetic Resonance ImagingProcedure or surgery
Also called Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan
Undergo MRI
PEOX-based Polymer Encapsulated Paclitaxel FID-007Drug
Also called FID 007, FID-007, FID007, Nanoencapsulated Paclitaxel FID-007
Given IV
Tumor ResectionProcedure or surgery
Undergo surgical resection
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Biospecimen Collection; Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging; Drug: PEOX-based Polymer Encapsulated Paclitaxel FID-007; Procedure: Tumor Resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline up to 30 days
Secondary outcomes (5)
Incidence of adverse events (AEs)
A summary table at subject level focusing on grade 3 or higher treatment related AEs (as per Common Terminology Criteria for Adverse Events version 5.0) will be provided.
Measured: Baseline up to 30 days
Major pathologic response rate
Major pathologic response defined as 1-10% viable tumor on surgical specimen. Will be calculated based on the proportions that we calculated in the patient samples and their two-sided 95% confidence interval will also be estimated using Exact Clopper-Pearson method.
Measured: Up to 30 days
Complete pathologic response rate
Complete pathologic response is defined as 0% viable tumor. Will be calculated based on the proportions that we calculated in the patient samples and their two-sided 95% confidence interval will also be estimated using Exact Clopper-Pearson method.
Measured: Up to 30 days
Rate of locoregional recurrence
Percentage of patients who develop local-regional recurrence (identification of disease growth) in the primary site or regional lymphatics based on imaging and/or clinical exam.
Measured: Within 2 years of surgery (surgery will occur approximately 3-6 weeks after last dose of FID-007)
Rate of distant metastasis
The percentage of patients who develop distant metastasis within 2 years of surgery. Distant disease is cancer that is found in another part of the body that is far away from where the original (primary) tumor first formed.
Measured: Within 2 years of surgery (surgery will occur approximately 3-6 weeks after last dose of FID-007)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2024
- Study start1 Apr 2024
- Primary completion3 Sep 2025
- Study completion9 Sep 2025
Why it stopped: Slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Jacob Thomas, MD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06338657
- Sponsor's protocol ID
- 7H-23-5
- Other IDs
- NCI-2024-01367, 7H-23-5, P30CA014089
- Status last verified
- Sep 2025
- First submitted
- 14 Mar 2024
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Window of Opportunity Study of Taxanes in Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT06338657
- Acronym / sponsor ID
- 7H-23-5
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow accrual
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 3 Sep 2025 (actual)
- Study completion
- 9 Sep 2025 (actual)
- First posted
- 29 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To describe the phenotypical and functional changes of different T cell subsets within the tumor microenvironment after treatment with FID-007.
SECONDARY OBJECTIVES:
- 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:
- 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (FID-007) | Experimental | Procedure: Biospecimen Collection, Procedure: Computed Tomography, Procedure: Magnetic Resonance Imaging, Drug: PEOX-based Polymer Encapsulated Paclitaxel FID-007, Procedure: Tumor ResectionPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Specimen CollectionUndergo blood sample collection | Procedure or surgery | Treatment (FID-007) |
| Computed TomographyAlso: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial TomographyUndergo CT scan | Procedure or surgery | Treatment (FID-007) |
| Magnetic Resonance ImagingAlso: Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging ScanUndergo MRI | Procedure or surgery | Treatment (FID-007) |
| PEOX-based Polymer Encapsulated Paclitaxel FID-007Also: FID 007, FID-007, FID007, Nanoencapsulated Paclitaxel FID-007Given IV | Drug | Treatment (FID-007) |
| Tumor ResectionUndergo surgical resection | Procedure or surgery | Treatment (FID-007) |
Primary outcome
Evaluate the phenotypical and functional changes of different T cell subsets within the tumor microenvironment after treatment with FID-007
Time frame: Baseline up to 30 days
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.
5 secondary outcomes
Incidence of adverse events (AEs)
Time frame: Baseline up to 30 days
Major pathologic response rate
Time frame: Up to 30 days
Complete pathologic response rate
Time frame: Up to 30 days
Rate of locoregional recurrence
Time frame: Within 2 years of surgery (surgery will occur approximately 3-6 weeks after last dose of FID-007)
Rate of distant metastasis
Time frame: Within 2 years of surgery (surgery will occur approximately 3-6 weeks after last dose of FID-007)
Results and safety
The study was stopped early (reason given: Slow accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacob Thomas, MD principal investigator
University of Southern California
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Biospecimen Collection, Computed Tomography and Magnetic Resonance Imaging in people with Head and Neck Squamous Cell Carcinoma, run by University of Southern California at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Slow accrual). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the phenotypical and functional changes of different T cell subsets within the tumor microenvironment after treatment with FID-007 (time frame: Baseline up to 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2025.