Full Title
Phase II Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy of HB-200 in Patients with Positive TTMV-HPV DNA after Definitive Treatment for HPV16 Positive HNSCCPurpose
Researchers want to see how well the drugs HB-202 and HB-201 work to keep head and neck cancer from coming back. The people in this study have squamous cell head and neck cancer that was already treated. They had a test that found HPV 16-related tumor DNA in their blood. However, there is no sign of cancer on their standard imaging tests or by a doctor’s examination. This could mean a higher risk of cancer recurrence. HPV 16 is a strain of human papilloma virus which can cause cancer.
HB-202/HB-201 works by training the immune system to recognize and fight against cancer. The drugs target proteins called E6 and E7. These proteins are found in HPV 16-positive head and neck cancer cells and play a role in cancer growth.
If you join this study, you will be randomly assigned to get either HB-202/HB-201 or a placebo (inactive drug). There is a higher chance you may get HB-202/HB-201 than the placebo. The medications are given intravenously (by vein). You will have doctor’s visits and imaging tests no matter which treatment you receive.
Who Can Join
To join this study, there are a few conditions. You must:
- Have completed treatment for squamous cell carcinoma of the head and neck.
- Show no signs of cancer on imaging tests or physical exams.
- Have tested positive for HPV 16-related tumor DNA in the blood using the NavDx test.
- Be well enough to walk and take care of yourself. You must be able to do activities such as office work or light housework.
- Be age 18 or older.
Contact
For more information and to see if you can join this study, please call Dr. Winston Wong’s office at 646-608-4245.
Protocol
23-293
Phase
Phase II (phase 2)
Disease Status
Relapsed or Refractory
Investigator
Co-Investigators
ClinicalTrials.gov ID
NCT06373380