Intraoperative Fluorescent Imaging Agent Under Study in Patients With Skin Cancer
Posted: Wednesday, September 8, 2021
The intraoperative fluorescent imaging agent tozuleristide (BLZ-100) was found to be well tolerated at all administered doses in patients with known or suspected skin cancers, according to Tarl W. Prow, PhD, of The University of Queensland, Brisbane, Australia, and colleagues. The results of this first-in-human, dose-escalation and -expansion study, which were published in the journal Contemporary Clinical Trials Communications, support further clinical testing of this novel agent in surgical oncology settings, such as during tumor resection, for example for brain or breast cancer.
“Tozuleristide…is composed of a modified chlorotoxin peptide and a covalently attached indocyanine green moiety,” the investigators explained. “The natural chlorotoxin peptide has been shown to bind tumors via a molecular interaction with protein components of cholesterol-rich lipid rafts, including annexin A2 and matrix metalloproteinase 2.”
A total of 2 days prior to excision, 21 patients with known or suspected nonmetastatic basal or squamous cell carcinoma or nonmetastatic melanoma were intravenously administered 1, 3, 6, 12, or 18 mg of tozuleristide. Fluorescence imaging was performed before and up to 48 hours after dosing.
Tozuleristide seemed to be well tolerated in this patient population. No serious adverse events, deaths, or treatment discontinuations due to adverse events were reported. The maximal tolerated dose was not reached. Headache (n = 2) and nausea (n = 2) were the most frequently reported treatment-related adverse events. The median duration of time to the maximal serum concentration was less than 0.5 hours. According to the investigators, exposure based on maximal serum concentrations increased in a greater than dose-proportional manner. Of the five patients with basal cell carcinomas who were administered intermediate doses (3–12 mg), four were considered positive for tozuleristide fluorescence; all patients with melanomas (n = 4) were considered positive for tozuleristide fluorescence.
Disclosure: For full disclosures of the study authors, visit sciencedirect.com.