A Phase I/II Study of HB-201 Administration Without and With Nivolumab in Human Papillomavirus 16 Positive (HPV 16+) Confirmed Cancers

Brief description of study

This is a research study for a new therapy called HB-20x that is being tested on people with certain types of cancer caused by HPV 16. It has two parts: Phase I Dose Escalation and Phase II Dose Expansion. Dose escalation means increasing the amount of medicine given to participants in the study to find the right dose that is both safe and beneficial. They start with a low dose and gradually increase it. Dose expansion means further exploring the chosen dose(s) of the medicine that showed promise in the earlier phase. They study more participants using the same dose(s) to gather more information about its effectiveness and safety. HB-201 and HB-202 are two types of special treatments made using modified viruses. They are designed to fight against a specific type of tumor caused by HPV 16. These treatments help the body's immune system to recognize and attack the tumor cells. In Phase I Dose Escalation, they will try two different treatments: HB-201 alone and HB-202 & HB-201 used together in a specific way. During Phase II Dose Expansion, they will further explore the HB-202 & HB-201 treatment alone, in combination with pembrolizumab (another drug), and with pembrolizumab and chemotherapy. The study will use imaging tests to evaluate participants with recurrent or metastatic HPV 16+ cancer and at least one measurable tumor. The HPV 16+ status will be confirmed by the doctor. The participants' response to the treatment will be assessed using specific criteria. The participants will be closely monitored for any side effects or adverse events throughout the study. They will be followed up for a certain period even after the treatment ends.




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