Panitumumab-IRDye800 and 89Zr-Panitumumab in Identifying Metastatic Lymph Nodes in Patients With Squamous Cell Head and Neck Cancer

Participants receive standard of care 18F-FDG-PET/CT and/or 18F-FDG-PET/MRI to assess their
cancer for surgical excision. Participants than receive panitumumab-IRDye800 dye and
89Zr-panitumumab, both by intravenous (IV) infusion, on Day 0. Participants will undergo
89Zr-panitumumab PET/CT imaging on Day 1 to 2, and then undergo surgical resection of the
tumor at 2 to 5 days after infusion. Participants with cancer-positive lymph nodes vs
cancer-negative lymph nodes will be analyzed as separate cohorts. Research imaging will be
performed intraoperatively using optical imaging devices and a high-energy gamma probe.
Subsequently, the excised tissue will evaluated ex vivo (back table) using radioactive
(89Zr-panitumumab) and fluorescence (panitumumab-IRDye800) imaging techniques. After surgery,
patients are followed up at 15 and 30 days.

PRIMARY OBJECTIVES:

I. Determine the sensitivity and specificity of zirconium Zr 89 panitumumab (89Zr
panitumumab) for the detection of tumor-involved regional lymph nodes.

SECONDARY OBJECTIVES:

I. Determine the number (proportion) of lymph nodes determined to be tumor positive by
histological and/or pathological evaluation that were NOT predicted tumor-positive by 89Zr
panitumumab labeling.

EXPLORATORY OBJECTIVES:

I. Determine the sensitivity and specificity of panitumumab IRDye800 for the detection of
tumor-involved regional lymph nodes.

II. Determine the number (proportion) of lymph nodes determined to be tumor positive by
histological and/or pathological evaluation that were NOT predicted tumor-positive by
panitumumab-IRdye800 labeling.

optical imaging devices listed in Appendix B intraoperative high-energy gamma probe.

Inclusion Criteria:

- Biopsy confirmed diagnosis of squamous cell carcinoma of the head and neck.

- Subjects diagnosed with any T stage, any subsite within the head and neck that are
scheduled to undergo surgical resection. Subjects with recurrent disease or a new
primary will be allowed.

- Planned standard of care surgery with curative intent for squamous cell carcinoma.

- Hemoglobin ≥ 9 gm/dL.

- White blood cell count > 3000/mm³.

- Platelet count ≥ 100,000/mm³.

- Serum creatinine ≤ 1.5 times upper reference range.

Exclusion Criteria:

- Received an investigational drug within 30 days prior to first dose of
panitumumab-IRDye800.

- Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive
heart failure (CHF); significant liver disease; or unstable angina within 6 months
prior to enrollment.

- Previous bilateral neck dissection.

- History of infusion reactions to monoclonal antibody therapies.

- Pregnant or breastfeeding.

- Magnesium or potassium lower than the normal institutional values.

- Subjects receiving class IA (quinidine, procainamide) or class III (dofetilide,
amiodarone, sotalol) antiarrhythmic agents.

- Subjects with a history or evidence of interstitial pneumonitis or pulmonary fibrosis.

- Severe renal disease or anuria.

- Known hypersensitivity to deferoxamine or any of its components.