protocolSection identificationModule nctId: NCT06338657, orgStudyIdInfo id: 7H-23-5, secondaryIdInfos id: NCI-2024-01367, type: REGISTRY, domain: CTRP (Clinical Trial Reporting Program), secondaryIdInfos id: 7H-23-5, type: OTHER, domain: USC / Norris Comprehensive Cancer Center, secondaryIdInfos id: P30CA014089, type: NIH, link: https://reporter.nih.gov/quickSearch/P30CA014089, briefTitle: FID-007 Followed by Standard of Care Surgery in Head and Neck Cancer, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-04, primaryCompletionDateStruct date: 2026-04-04, completionDateStruct date: 2027-04-04, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: University of Southern California, class: OTHER, collaborators name: National Cancer Institute (NCI), descriptionModule briefSummary: 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., conditionsModule conditions: Head and Neck Squamous Cell Carcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: Biospecimen Collection, interventions name: Computed Tomography, interventions name: Magnetic Resonance Imaging, interventions name: PEOX-based Polymer Encapsulated Paclitaxel FID-007, interventions name: Tumor Resection, outcomesModule primaryOutcomes measure: Evaluate the phenotypical and functional changes of different T cell subsets within the tumor microenvironment after treatment with FID-007, secondaryOutcomes measure: Incidence of adverse events (AEs), secondaryOutcomes measure: Major pathologic response rate, secondaryOutcomes measure: Complete pathologic response rate, secondaryOutcomes measure: Rate of locoregional recurrence, secondaryOutcomes measure: Rate of distant metastasis, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Los Angeles General Medical Center, city: Los Angeles, state: California, zip: 90033, country: United States, contacts name: Sandy Tran, MS, role: CONTACT, phone: 323-865-0451, email: Sandy.tran@med.usc.edu, contacts name: Jacob S. Thomas, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.05223, lon: -118.24368, locations facility: USC / Norris Comprehensive Cancer Center, city: Los Angeles, state: California, zip: 90033, country: United States, contacts name: Sandy Tran, MS, role: CONTACT, phone: 323-865-0451, email: Sandy.tran@med.usc.edu, contacts name: Jacob S. Thomas, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.05223, lon: -118.24368, hasResults: False