Combining Neo-adjuvant ATR-inhibition With Nodal SBRT for Early-stage Resectable HPV+ OPSCCs

Exclusion Criteria

• •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
• •Patients that have a known additional malignancy that is progressing or requires active treatment
• •Patients that had a surgical procedure performed within 7 days prior to first scheduled dose of ATRN-119. This does not include procedures that are used to diagnose or determine extent of study disease (such as biopsies).
• •Patients taking medications that strongly affect how the body processes certain drugs (CYP enzymes) at the same time as the study treatment.
• •Patients with active infections and/or receiving systemic antibiotics or anti-viral medications.
• •Current or past diagnosis of leukemia within the past 5 years.
• •Patients with a history of non-malignant gastrointestinal (GI) bleeding, gastric stress ulcerations, or peptic ulcer disease within the past 3-months.
• •Patient has uncontrolled hypertension at time of enrollment.
• •Patients who recently had serious kidney problems or kidney disease.
• •Patients cannot have taken another experimental drug within 30 days-or within a period equal to five times that drug's half-life-before starting this study
• •Medical illness that, in the opinion of the Investigator, may impact the safety of the patient
• •Patients who use recreational drugs or have mental health conditions that might make it hard to follow study visits, based on the doctor's judgment.
• •Known hypersensitivity to ATRN-119 or its ingredients
• •Patients with serious liver disease or liver problems that could affect how the body processes the study drug
• •Patients who are fairly limited in daily activities (ECOG score of 2 or higher)
• •Patients with serious other health problems that the doctor thinks could prevent them from completing the study
• •Pregnancy or lactation
• •Inability to provide informed consent