Pegsitacianine for the Detection of Cancer in Patients with Unknown Primary Head and Neck Cancer or Head and Neck Squamous Cell Cancer

Inclusion Criteria

• Adults ≥ 18 years of age
• Biopsy-confirmed diagnosis for primary or recurrent disease (or high clinical suspicion in the opinion of the investigator) * Part 1: Stage 0 to 4 HNSCC * Part 2: Stage 0 to 4 UPC of the head and neck
• Acceptable hematologic status (as respective standard surgery protocol requires, as determined by the investigator), kidney function, and liver function. Elevations of creatinine, alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (AP), or total bilirubin ≥ 1.5× upper limit of normal (ULN) must be determined to be not clinically significant by the investigator
• Documented negative serum pregnancy test for women of childbearing potential (i.e., premenopausal women with intact reproductive organs and women < 2 years after menopause)
• Male patients and female patients of child-bearing potential (i.e., premenopausal women with intact reproductive organs and women < 2 years after menopause) must agree to and comply with using medically acceptable contraception including surgical sterilization (e.g., hysterectomy, bilateral oophorectomy, bilateral tubal ligation), intrauterine device, oral contraceptive, contraceptive patch, long acting injectable contraceptive, partner’s vasectomy, double-barrier method (condom or diaphragm plus spermicide or condom plus diaphragm), or abstinence during the trial and for 6 months thereafter
• Agree to abstain from alcohol consumption from 72 hours before pegsitacianine administration through completion of study day 6 (± 24 hours) visit in part 1 and through completion of study day 10 (± 48 hours) visit in part 2
• Adequate potential for follow up
• Willing and able to provide written informed consent

Exclusion Criteria

• Tumors at sites of which the surgeon would assess that in vivo intraoperative imaging would not be feasible
• Life expectancy < 12 weeks
• Karnofsky performance status < 70%
• Hepatic impairment (Child-Pugh score > 5) or significant liver disease including active hepatitis or cirrhosis
• Lab values or any sign, symptom, or medical condition that in the opinion of the principal investigator (PI) would prevent surgical resection
• Any known hypersensitivity or allergy to any of the components of pegsitacianine (e.g. Poly ethylene glycol [PEG], polymethyl methacylate [PMMA] and indocyanine green)
• Medical or psychiatric conditions that compromise the patient’s ability to give informed consent
• Pregnant or lactating women
• Receiving or planned to receive, during the duration of the study, concomitant medication with a high chance of hepatotoxicity, as judged by the PI based on standard protocols within the study center
• Alcohol consumption within 72 hours before pegsitacianine administration
• Received an investigational agent within the shorter of 5 half-lives or 30 days before pegsitacianine dosing
• Inability to adhere to the schedule of assessments or any circumstance that would interfere with the validity of assessments performed in the study
• The PI considers that the patient should not participate in the study