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ACTIVE NOT RECRUITING
NCT06713564
PHASE1

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

Sponsor: Integro Theranostics

View on ClinicalTrials.gov

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.

Official title: A Phase 1b, Single Dose, Open-Label, Dose-escalation Study to Investigate the Safety and Imaging Characteristics of LS301-IT for Intraoperative Imaging of Lung Cancer

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

24

Start Date

2024-11-07

Completion Date

2026-03

Last Updated

2025-12-02

Healthy Volunteers

No

Conditions

Interventions

DRUG

LS301-IT

LS301 is composed of: 1) a cyclic peptide that binds phosphorylated Annexin A2 (ANXA2) which is found on the surface of malignant cells typically located in solid tumors and in malignant lymph nodes; and 2) cypate, a near infrared (NIR) molecule conjugated to the peptide, which fluoresces when illuminated using NIR light.

Locations (1)

University of Pennsylvania

Philadelphia, Pennsylvania, United States