drugset / Trial / NCT06145048
Phase 2B Safety and Efficacy Study of VGT-309 in Subjects With Cancer in the Lung.
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Abenacianine | Diagnostic / imaging agent | 0.32 mg/kg | Intravenous |