This is a non-randomized, open-label, single-center, safety and imaging feasibility study of Pegsitacianine, an intraoperative fluorescence imaging agent.
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 1 to 4 HNSCC
Part 2: UPC squamous cell carcinoma of the head and neck with metastatic disease to at least a single cervical node, AND no biopsy proven evidence of the primary cancer's location.
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
Parallel
Pegsitacianine
DrugInfusion of the Pegsitacianine-Intraoperative fluorescence imaging
Diagnostics performance and safety of 1 mg/kg Pegsitacianine in patients with HNSCC
Pegsitacianine fluorescence from in vivo and excised tissues will be imaged using intraoperative and post-operative NIR cameras and will be correlated with the histopathological confirmation of tumor and normal tissues to determine Pegsitacianine's diagnostic performance. Patient safety will be assessed for 10 days (±48 hours) post dose. All patients will be monitored for vital signs and physical examination pretreatment and at various time points up to Day 6 (±24 hours). All patients will be monitored for comprehensive metabolic panel (CMP) and complete blood count (CBC) with differentials pretreatment and at various time points up to Day 10 (±48 hours). All patients will be monitored for TEAEs, and concomitant medication use from the start of dosing up to Day 10 (±48 hours). TEAEs will be followed closely during the study to identify any potential DLTs
Diagnostics performance and safety of 1 mg/kg Pegsitacianine in patients with UPC
Pegsitacianine fluorescence from in vivo and excised tissues will be imaged using intraoperative and post-operative NIR cameras and will be correlated with the histopathological confirmation of tumor and normal tissues to determine Pegsitacianine's diagnostic performance. Patient safety will be assessed for 10 days (±48 hours). All patients will be monitored for vital signs and physical examination pretreatment and at various time points up to Day 6 (±48 hours). All patients will be monitored for comprehensive metabolic panel (CMP) and complete blood count (CBC) with differentials pretreatment and at various time points up to Day 10 (±48 hours). All patients will be monitored for TEAEs, and concomitant medication use from the start of dosing up to Day 10 (±48 hours). TEAEs will be followed closely during the study to identify any potential DLTs
Pegsitacianine fluorescence imaging in HNSCC, UPC primary cancers that are HPV positive and HPV negative
Pegsitacianine fluorescence from in vivo and excised tissues will be imaged using intraoperative and post-operative NIR cameras and will be correlated with the histopathological confirmation of tumor and normal tissues to determine Pegsitacianine's diagnostic performance. Assessment of use of Pegsitacianine for intra-operative imaging of HNSCC, UPC and metastatic lymph nodes will include quantification of intraoperative and postoperative fluorescence signals from histology confirmed tumor and normal tissues, calculation of TBR and diagnostic performance. Feasibility determination will be based on a combined assessment of intraoperative in vivo and ex vivo fluorescent signals together with ex vivo examinations (histological examination, NIR flatbed scanning).
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University of Texas Southwestern Medical Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator
