LAUSR

Abstract Objectives VGT-309 (abenacianine) is being evaluated as an intraoperative molecular imaging (IMI) agent. This phase 2, open-label, dose-ranging study evaluated efficacy and safety in participants undergoing surgical resection of suspicious or proven cancer in the lung. Methods Adults who consented to participate in the study were assigned to treatment with VGT-309 at 0.05, 0.16, or 0.32 mg/kg dose administered 2-6 or 12-36 hours presurgery. Intraoperative tumour fluorescence intensity and contrast were assessed to inform efficacy across dosing parameter. Ex vivo imaging of surgical specimens was performed before and after histopathology. Results Twenty-seven participants received VGT-309. No lesions were visualized in participants receiving 0.05 mg/kg or 0.16 mg/kg administered 2-6 hours presurgery. Near-infrared (NIR) imaging after treatment with 0.16 mg/kg 12-36 hours presurgery identified 3 of 4 lesions from 3 of 4 participants. Sixteen participants were administered 0.32 mg/kg; 6 dosed 2-6 hours and 10 dosed 12-36 hours presurgery. IMI identified 6 of 7 lesions from 5 of 6 participants dosed 2-6 hours presurgery, while 8 of 11 lesions from 7 of 10 participants dosed 12-36 hours presurgery displayed intraoperative fluorescence. A single suspected unexpected serious adverse reaction of liver transaminitis resolved within 30 days. Otherwise, VGT-309 was safe and well tolerated in this study. Conclusions Results support the safety and efficacy of VGT-309 in identifying cancer in the lung with 0.16 mg/kg day-before surgery dosing and 0.32 mg/kg at either dosing schedule. Clinical Trial Registration Number ACTRN12621000301864.