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

Integro Theranostics

Status and phase: Enrolling; Phase 1

Conditions: Lung Cancers

Treatments: Drug: LS301-IT

Study type: Interventional

Funder types: Industry

Identifiers

NCT06713564

LS301-IT-B102

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

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24 participants in 4 patient groups

LS301-IT Cohort -1

Experimental group

Description:

0.0125 mg/kg LS301-IT administered by IV infusion over approximately 15 minutes the day before surgery

Treatment:

Drug: LS301-IT

LS301-IT Cohort 1

Experimental group

Description:

0.025 mg/kg LS301-IT administered by IV infusion over approximately 15 minutes the day before surgery

Treatment:

Drug: LS301-IT

LS301-IT Cohort 2

Experimental group

Description:

0.05 mg/kg LS301-IT administered by IV infusion over approximately 15 minutes the day before surgery

Treatment:

Drug: LS301-IT

LS301-IT Cohort 3

Experimental group

Description:

0.075 mg/kg LS301-IT administered by IV infusion over approximately 15 minutes the day before surgery

Treatment:

Drug: LS301-IT