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

Phase 1

Recruiting

• Conditions: Lung Cancers
• Interventions: Drug: LS301-IT

• Registration Number: NCT06713564
• Lead Sponsor: Integro Theranostics

Brief 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.

Detailed Description

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.

Study Timeline

• Status Verified: 2024-11
• Study Start: 2024-11-07
• Study First Submitted: 2024-11-19
• Study First Submitted QC: 2024-11-27
• Last Update Submitted: 2024-11-27
• Study First Posted: 2024-12-03
• Last Update Posted: 2024-12-03
• Primary Completion: 2025-06
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
LS301-IT Cohort 1	LS301-IT	0.025 mg/kg LS301-IT administered by IV infusion over approximately 15 minutes the day before surgery
LS301-IT Cohort 2	LS301-IT	0.05 mg/kg LS301-IT administered by IV infusion over approximately 15 minutes the day before surgery
LS301-IT Cohort 3	LS301-IT	0.075 mg/kg LS301-IT administered by IV infusion over approximately 15 minutes the day before surgery
LS301-IT Cohort -1	LS301-IT	0.0125 mg/kg LS301-IT administered by IV infusion over approximately 15 minutes the day before surgery

Primary Outcome Measures

Name	Time	Method
Number of Patients with Dose Limiting Toxicities	2 to 7 days after dosing	Dose Limiting Toxicity - Any CTCAE Grade 2, 3, 4, or 5 AE (any treatment emergent sign or symptom) at least possibly related to IMP will be considered a DLT, as well as any other AE deemed clinically relevant by the SRC.
Number of Patients that discontinue the study or have their surgery cancelled due to toxicity	From start of dosing to time of surgery	Treatment discontinuation and/or surgery cancellation due to toxicity (hypersensitivity reaction to LS301-IT)

Trial Locations

Locations (1)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States