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

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.