drugset / Trial / NCT06713564
A Single Dose, Open-Label, Dose-escalation Study of the Safety and Imaging Characteristics of LS301-IT for Intraoperative Imaging of Lung Cancer
Non-randomizedSequentialSingle-blindTreatment
Summary
The aim of this Phase 1b study is to investigate the safety and fluorescence signal of a single dose of LS301-IT, a novel fluorescence imaging agent developed by Integro Theranostics (IT), administered by slow intravenous (IV) administration in patients undergoing surgical thoracoscopy and resection of lung cancer. Safety is the primary objective of this study, followed by the evaluation of the fluorescence signal as it relates to dose level and dosing time interval.
Timeline
- Start
- 2024-11-07
- Primary completion
- 2026-05-06
- Completion
- 2026-05-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | LS301-IT | Diagnostic / imaging agent | 0.0125 mg/kg | Intravenous |
| Subject | LS301-IT | Diagnostic / imaging agent | 0.025 mg/kg | Intravenous |
| Subject | LS301-IT | Diagnostic / imaging agent | 0.05 mg/kg | Intravenous |
| Subject | LS301-IT | Diagnostic / imaging agent | 0.075 mg/kg | Intravenous |