drugset / Trial / NCT06145048

Phase 2B Safety and Efficacy Study of VGT-309 in Subjects With Cancer in the Lung.

NCT06145048 ↗

Phase 2 Completed 89 enrolled Vergent Bioscience, Inc.
NaSingle-groupOpen-labelTreatment

Summary

This is a Phase 2, multi-center, open-label study to evaluate the safety and efficacy of VGT-309, a tumor-targeted, activatable fluorescent imaging agent, in subjects undergoing surgery for proven or suspected cancer in the lung. Approximately 100 subjects will be enrolled to ensure at least 86 subjects are evaluable with the option to expand enrollment by protocol amendment if deemed necessary by the DSC to meet primary and/or secondary objectives.

Timeline

Start
2023-10-05
Primary completion
2024-10-31
Completion
2025-02-20

Outcome

Met primary endpoint

release “Phase 2B study of tumor-targeted fluorescent imaging agent met primary efficacy endpoint, showing abenacianine helped surgeons see tumor tissue missed by standard surgical techniques” vergentbio.com ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Abenacianine Diagnostic / imaging agent 0.32 mg/kg Intravenous

Indications