This Window of Opportunity clinical trial will examine the immunologic effects of the study agent HB-201 in the head and neck or cervical cancer, when administered by IV route.
The window of opportunity, Study H-200-002, will examine the effects of study agent (HB-201) on subjects during the "window" between diagnosis of their cancer and their definitive cancer surgery or chemoradiation. The study will be a 2-arm study design. In Arm 1, the study will enroll subjects with resectable stage I-III human papillomavirus 16 positive (HPV 16+) genotype squamous cell cancer of the oropharynx or unknown primary cancer site who are candidates for transoral surgery. Participants will receive a single intravenous dose of the study agent HB-201 prior to transoral surgery administered intravenously. In Arm 2, the study will enroll cervical cancer subjects who have histologically confirmed newly diagnosed advanced squamous cell carcinoma, adenocarcinoma, and/ or adenosquamous cell carcinoma with HPV 16+ genotype clincal stages IB to IVB with plan for initial treatment of definitive chemoradiation. Participants will receive a single intravenous dose of HB-201 prior to the start of chemoradiation.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Froedtert Hospital and the Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Immune response profiles in subjects with HPV 16+ Head and Neck and cervical cancer.
Measurement of antigen-specific CD8+ T cells in blood and tissue (E7E6 antigen specific assay).
Time frame: Approximately 6-8 weeks
Assessment of gene expression and tumor mutational burden (TMB, MSI) in tumor specimens.
Pre and post administration of HB-201
Time frame: Approximately 6-8 weeks
Investigate metabolic and proteomics changes in serum and plasma.
Pre and post administration of HB-201
Time frame: Approximately 6-8 weeks
Investigate the t-cell receptor repertoire diversity and clonality.
Pre and post administration of HB-201.
Time frame: Approximately 6-8 weeks
Clinical evidence of response to HB-201
Change in tumor size per RECIST v1.1
Time frame: Approximately 6-8 weeks
Toxicity profile of HB-201
Number and type of adverse events per CTCAE v5.0
Time frame: Approximately 30 days post HB-201 administration
Other Exploratory Biomarker research may be conducted on any tumor tissue and/or blood samples collected during the study.
Time frame: Approximately 6-8 weeks
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