NCT06145048

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 89 (actual)
• Sponsor: Vergent Bioscience, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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. Following agreement with and signing of the informed consent, subjects will undergo screening measurements for the study within 4 weeks prior to the anticipated dosing: 1. Medical, surgical and medication history. 2. Complete physical exam, including vital signs and height 3. Weight (needed for dose calculation) 4. Chemistry, hematology, coagulation and urinalysis with microscopy clinical laboratory studies. 5. 12-lead ECG. 6. Serum pregnancy test for females of child-bearing potential. After meeting all enrollment criteria, each subject will receive 0.32 mg/kg VGT-309 by IV administration 12-36 hours prior to surgery (refer to section VGT-309 Dosing, below). Subjects will be observed for 1 hour after dosing is completed and asked about possible treatment emergent adverse events. Subjects will undergo surgical resection within 12-36 hours after completion of VGT-309 dosing. Measurements of efficacy will be taken during surgery and during the pathological examination of all surgical specimens. (Refer to Efficacy Endpoints and Efficacy Assessments sections). Following surgery, subjects will be monitored for safety during their hospitalization. Between 7 to 14 and 25 to 35 days after surgery, the subjects will return to the clinic or have a telehealth visit for final safety assessments. At the last visit, if there are no adverse events requiring further follow up, subjects will then be released from the study.

Conditions

• Lung Cancer
• Lung Metastases

Interventions

Type	Name	Description
DRUG	VGT-309	Intravenous drug to be given over 15-20 minutes by syringe pump.

Timeline

• Start date: 2023-10-05
• Primary completion: 2024-10-31
• Completion: 2025-02-20
• First posted: 2023-11-22
• Last updated: 2025-03-28

Locations

6 sites across 2 countries: United States, Australia

Regulatory

• FDA-regulated drug study