UPCC 13524 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

Investigating the Safety and Use of an Investigational Agent for Lung Cancer Surgery

Enrolling By Invitation
18 years or above
All
Phase 1
24 participants needed
1 Location

Brief description of study

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.

Detailed description of study

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.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Lung Cancers
  • Age: 18 years or above
  • Gender: All

Inclusion Criteria:

  • ECOG performance status of 0 to 2
  • Have a primary diagnosis, or a high clinical suspicion, for cancer in the lung based on CT, biopsy, or other imaging.
  • Are scheduled to undergo surgical thoracoscopy and resection of the lung.

Exclusion Criteria:

  • Contraindications for surgery or any medical condition that in the opinion of the investigator could jeopardize the safety of the subject
  • No planned surgical use of any other fluorescent optical imaging agent, or exposure to another optical imaging agent within 8 weeks prior to surgery

History of any drug-related hypersensitivity or anaphylactic reactions, including those attributed to indocyanine green (ICG) or other agents used in the study, or known shellfish allergies.

Known sensitivity to near infrared light

Patients with impaired renal function as defined by a creatinine clearance (CrCl) <60 mL/min at Screening, according to the Cockcroft-Gault formula ((140 - age) × body weight/plasma creatinine × 72 (× 0.85 for female)

History, or presence in the ECG at Screening, of any clinically significant abnormalities including cardiac conduction abnormalities such as Fridericia's corrected QTc interval (QTcF) > 470 ms

This study investigates the safety and imaging characteristics of an investigational fluorescence agent in patients undergoing surgery for lung cancer. The purpose is to evaluate how this agent, administered intravenously, helps visualize tumor margins during surgical procedures. The study focuses on patients with a primary diagnosis or high suspicion of lung cancer based on imaging or biopsy results.

Participants will receive a single dose of the investigational agent, and the study will monitor the safety and fluorescence signal of the agent. The study will include up to 24 patients divided into four different dose levels. Safety assessments will guide dose adjustments for subsequent participants.

  • Who can participate: Adults with an ECOG performance status of 0 to 2, with a primary diagnosis or high suspicion of lung cancer and scheduled for surgical thoracoscopy and resection, may participate. Exclusions include contraindications for surgery, known hypersensitivity to study agents, and impaired renal function.
  • Study details: Participants will receive a single dose of the investigational agent before their lung cancer surgery. The study will monitor the agent's safety and effectiveness in aiding surgeons to visualize tumor margins.
Updated on 28 Jul 2026. Study ID: 24-1527
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