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Phase 2B Safety and Efficacy Study of VGT-309 in Subjects With Cancer in the Lung.
Sponsor: Vergent Bioscience, Inc.
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.
Official title: 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 Cancer in the Lung
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
89
Start Date
2023-10-05
Completion Date
2025-02-20
Last Updated
2026-05-13
Healthy Volunteers
No
Conditions
Interventions
VGT-309
Intravenous drug to be given over 15-20 minutes by syringe pump.
Locations (6)
City of Hope National Medical Center
Duarte, California, United States
Orlando Health Cancer Institute
Orlando, Florida, United States
Mayo Clinic
Rochester, Minnesota, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
St. Vincent's Hospital
Melbourne, Victoria, Australia