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

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

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 Overview

• Status: Completed
• Conditions: Lung Cancers
• Intervention / Treatment: Drug: LS301-IT

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 Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LS301-IT Cohort -1; 0.0125 mg/kg LS301-IT administered by IV infusion over approximately 15 minutes the day before surgery	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.
Experimental: LS301-IT Cohort 1; 0.025 mg/kg LS301-IT administered by IV infusion over approximately 15 minutes the day before surgery	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.
Experimental: LS301-IT Cohort 2; 0.05 mg/kg LS301-IT administered by IV infusion over approximately 15 minutes the day before surgery	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.
Experimental: LS301-IT Cohort 3; 0.075 mg/kg LS301-IT administered by IV infusion over approximately 15 minutes the day before surgery	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Patients with Dose Limiting Toxicities	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.	2 to 7 days after dosing
Number of Patients that discontinue the study or have their surgery cancelled due to toxicity	Treatment discontinuation and/or surgery cancellation due to toxicity (hypersensitivity reaction to LS301-IT)	From start of dosing to time of surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum observed plasma concentration (Cmax) in ng/mL	Cmax of LS301 and its main metabolite	Samples collected up to 24 hours after dosing
Area under the plasma concentration time curve from time 0 extrapolated to infinite time (AUC0-∞ [AUCinf]) in ng*hr/mL	AUC of LS301 in plasma.	Over 24 hours after dosing
Area under the plasma concentration-time curve from time 0 to the last quantifiable plasma concentration (AUC0-t [AUClast]) in ng*hr/mL	LS301 concentration in plasma	over 24 hours after dosing
Time to reach maximal plasma concentration (Tmax) in minutes	LS301 concentration in plasma	over 24 hours after dosing
Elimination/apparent terminal elimination half- life (t1/2) in minutes	LS301 concentration in plasma	24 hours after dosing

Collaborators and Investigators

• Sponsor: Integro Theranostics
• Investigators: Study Director: Robert Honigberg, MD, Integro Theranostics

Study record dates

Study Major Dates

• Study Start (Actual): November 7, 2024
• Primary Completion (Actual): May 6, 2026
• Study Completion (Actual): May 6, 2026

Study Registration Dates

• First Submitted: November 19, 2024
• First Submitted That Met QC Criteria: November 27, 2024
• First Posted (Actual): December 3, 2024

Study Record Updates

• Last Update Posted (Actual): May 19, 2026
• Last Update Submitted That Met QC Criteria: May 18, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: lung cancer imaging; lung cancer surgery
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: LS301-IT-B102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No