Study Evaluating [18F]NOTA-ABY030 for Safety and Tolerability of Indeterminate Primary and/or Metastatic Disease in Head and Neck Squamous Cell Carcinoma

Inclusion criteria

• Age ≥ 18 years.
• Subjects diagnosed with any T stage, any subsite within the head and neck. Subjects with recurrent disease or a new primary will be allowed.
• Must have evidence of indeterminate metastatic and/or primary SCC based on clinical imaging or Primary SCC with suspicious Lymph Nodes standard image modalities prior to surgical removal
• Have acceptable lab values, including the following clinical results (if values are considered clinically significant per investigator, participants must be asymptomatic):

• Hemoglobin ≥ 9gm/dL
• White blood cell count > 3000/mm3
• Platelet count ≥ 100,000/mm3
• Serum creatinine ≤ 1.5 times upper reference range
• Potassium
• Magnesium
• Phosphorus

Exclusion criteria

• Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); significant liver disease; or unstable angina within 6 months prior to enrollment.
• Prior severe infusion reactions or hypersensitivity to other monoclonal antibody therapies.
• Pregnant (based on Screening serum or urine pregnancy test administered before infusions), or breastfeeding.
• Participants with known hypersensitivity to NOTA-ABY-030, cetuximab, murine, or any of the drug components used in this trial.
• Subjects with history or evidence of interstitial pneumonitis or pulmonary fibrosis.
• Severe renal disease or anuria.
• Participants presenting with a baseline QTcF interval > than 480 milliseconds.
• Those with an allergy to red meat, a history of tick bites, and alpha-gal syndrome will be given extra consideration.