A Phase 2, open-label study to evaluate the safety and efficacy of VGT-309, a tumor-targeted, activatable fluorescent imaging agent, to identify cancer in subjects undergoing lung cancer surgery. A total of 40 subjects will be enrolled to ensure at least 38 evaluable subjects with the option to expand enrollment by protocol amendment if deemed necessary to meet primary and/or secondary objectives.~Following agreement with and signing of the informed consent, subjects will undergo screening measurements for the study. Assessments include the following, unless they have been done within 4 weeks prior to the anticipated dosing:~Medical, surgical and medication history.~Complete physical exam, including vital signs and weight.~Standard pre-operative chemistry, hematology, coagulation and urinalysis clinical laboratory studies.~12-lead ECG.~Serum pregnancy test for females of child-bearing potential.~Following clearance of all enrollment criteria, each subject will receive an IV administration of 0.32 mg/kg VGT-309 at 12-36 hours prior to surgery (refer to section VGT-309 Dosing, below). Upon dosing, subjects will be observed for up to 2 hours and asked about possible treatment emergent adverse events.~Subjects will undergo surgical resection as planned and within the time specified following VGT-309 dosing. Measurements of efficacy will be taken during surgery and during the pathological examination of all surgical specimens.~Following surgery, subjects will be monitored for safety during their hospitalization. After discharge from the hospital, and approximately 14 days post-surgery, the subjects will be contacted by telephone to assess their well-being. Between 19 to 39 days post-surgery, subjects will either return to the clinic or participate in a telehealth visit for final safety assessments. If there are no adverse events requiring further follow up, subjects will then be released from the study.
A Phase 2 open label study to evaluate safety and efficacy of VGT-309 to identify cancer in up to 40 subjects undergoing lung cancer surgery.