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
Single group
ATRN-119
DrugATRN-119 at 800 mg QD (every day) for 10 days
Stereotactic Body Radiation Therapy (SBRT)
Radiation10 Gy administered to nodal disease (neck) only on day 3 of ATRN-119 dosing
Phase Ib: Feasibility of a neo-adjuvant approach combining ATRN with SBRT before TORS
This will be judged by whether patients are able to have their planned surgery within 6 weeks after the study treatment, and whether there are no problems during surgery that the study doctor believes were caused by the study treatment.
Phase II: Major pathologic response (MPR) rate of radiated nodal disease
Researchers will measure how many patients have a strong treatment response in the affected lymph nodes that were treated with radiation, based on what is seen when the tissue is examined.
Phase II: To assess safety of ATR inhibitor ATRN-119 with nodal SBRT prior to surgery
This will be judged based on whether there are any surgery problems that the study doctor thinks were caused by the earlier treatment, as well as any side effects from the treatment.
Phase II: Radiographic response rates
This looks at how many patients' tumors shrink or improve based on imaging tests like scans. This is assessed by comparing pre- and post- study treatment MRI (or CT) Neck scans using typical descriptive changes noted by a head and neck specialized radiologist.
Phase II: Type of adjuvant treatment required
Percentage of patients requiring additional radiation therapy +/- chemotherapy after their main treatment as compared to historic controls (e.g. 75% requiring RT, 25% requiring chemotherapy). Additional therapy is determined by the participant's care team as part of their standard of care treatment, so not all patients will receive additional radiation or chemotherapy.
Phase II: Pathologic response of primary tumor and nodal disease
This looks at how strongly the main tumor and the affected lymph nodes respond to treatment. Pathologic response rates will be determined by comparing pre- and post- surgery tumor tissue samples for patients who have enough pre-op tissue to analyze from pathology.
Phase II: Relapse-free survival (RFS) at two years
Participants will be checked over a 2-year period to see if their disease comes back. A "relapse" means the disease returns either in the same place, nearby areas, or elsewhere in the body. Any return of the disease must be confirmed with medical testing (like examining tissue under a microscope).
Phase II: Measures of activation of anti-tumor immunity in primary tumor and blood
Researchers will study samples taken from each patient's main tumor and blood both before and after treatment given prior to the main therapy. This helps them see how the treatment affects the cancer and the body.
Click on the lead sponsor to view all of their trials.
Abramson Cancer Center at Penn Medicine
Lead sponsor
Aprea Therapeutics
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
