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 who are candidates for transoral surgery. Participants will receive a single dose of the study agent HB-201 prior to transoral surgery. Arm 1 will consist of 2 Cohort groups; Cohort 1 will enroll subjects receiving HB-201 as an intratumoral injection and Cohort 2 will enroll patients receiving HB-201 administered intravenously.~In Arm 2, the study will enroll cervical cancer subjects who have locally advanced squamous cell carcinoma, adenocarcinoma, and/ or adenosquamous cell carcinoma with HPV 16+ genotype. Subjects with advanced/metastatic disease that are previously untreated who are planning to undergo upfront chemoradiation for local control are eligible and will receive an intratumoral injection of HB-201 prior to the start of chemoradiation.
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 either by IT injection or by IV route.