This research study is testing whether a new study drug (called ATRN-119) is safe and effective when combined with a single, highly targeted dose of radiation therapy (called stereotactic body radiation therapy or SBRT) to treat early-stage throat cancer that is caused by HPV.
The goal of this study is to treat cancer effectively while reducing side effects and helping patients maintain a better quality of life over the long term. Researchers hope that this approach will be just as successful-or possibly more successful-than current treatments, which already have high cure rates.
Participants will:
* Take 800mg of ATRN-119 every day for 10 days * Receive 1 treatment (called a "fraction") of SBRT to the neck on day 3 of ATRN-119 dosing. * Keep a short diary to track ATRN-119 dosing. The diary will be provided by study team * Receive standard of care treatment after treatment with ATRN-119 + SBRT including TransOral Robotic Surgery (TORS) to remove the primary tumor with Neck Dissection and adjuvant therapy (if indicated) * Receive additional safety checkups and tests by researchers during routine visits with their cancer doctor for 2 years after study treatment
Age ≥ 18
Patients that have been diagnosed with HPV-positive throat cancer (OPSCC) at an early stage (stage I or II), confirmed by a biopsy.
Patients' blood calcium level is within a safe range
Patients' blood, kidney, and liver health are strong enough, shown through specific medical test results
Patients with late-stage tumors (Stage III or IV)
If the cancer has already spread to distant parts of the body (M1) when first diagnosed
Prior advanced head and neck cancer requiring radiation or major surgery
Patients whose original tumor site cannot be identified
Abramson Cancer Center at Penn Medicine
Lead sponsor
Aprea Therapeutics
Collaborator