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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06713564.
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.
Lead OrganizationIntegro Theranostics
Principal InvestigatorRobert Honigberg
