A Phase 0 Trial of HB-201 for Subjects with Transoral Resectable Human Papillomavirus 16 Positive (HPV 16+) Oropharynx Cancer or with Locally Advanced Cervical Cancer Treated with Chemotherapy and Radiation

Protocol No
Early Phase I

A Phase 0, window of opportunity clinical trial permits examination of effects of study agent on subjects during the “window” between diagnosis of their cancer and their definitive cancer surgery. This trial design permits examination of the biologic effects of a study agent. In
this trial we will examine immunologic effects of HB-201. In the head and neck arm, the study agent will be administered on the day of HB 201 administration either by IT injection or by IV route. In the cervical arm, IT injection will be administered one time 7 to 14 days prior to
definitive chemoradiation.

To investigate how HB-201 affects the immune response
profiles in subjects with HPV 16+ head and neck cancer (HNC) and cervical cancer. To compare the immunologic response of HB-201 when it is administered as an IV or IT injection.
Participating Institutions
Froedtert Hospital