A Single Dose, Open-Label, Dose-escalation Study of the Safety and Imaging Characteristics of LS301-IT for Intraoperative Imaging of Lung Cancer

Overview

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.

This is a Phase 1b, open-label study to investigate the use of LS301-IT (investigational medicinal product \[IMP\]), a fluorescence imaging agent used for visualization of tumor margins and other suspicious nodules in patients with primary diagnosis, or a high clinical suspicion, for cancer in the lung based on CT, biopsy, or other imaging. Up to 24 patients (4 dose cohorts, up to 6 patients each) for Phase 1b study (total of 24 patients maximum). There will be no stratification by dosing interval or lung cancer type (e.g., lung adenocarcinoma, lung squamous cell carcinoma). As safety is the primary objective of this study, the safety of each dose level will be assessed by the Safety Review Committee (SRC). Based upon the safety results of the first cohort, the SRC will recommend to the Sponsor which dose levels of LS301-IT may be administered in subsequent cohorts.

Conditions

Interventions

Eligibility

Locations (1)

Outcomes