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

NCT06713564 | Active Not Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: LS301-IT-B102
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancers

Keywords

lung cancer imaging; lung cancer surgery

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Maximum observed plasma concentration (Cmax) in ng/mL

  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

  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

  over 24 hours after dosing

Study Arms (4)

LS301-IT Cohort -1

EXPERIMENTAL

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

Drug: LS301-IT

LS301-IT Cohort 1

EXPERIMENTAL

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

Drug: LS301-IT

LS301-IT Cohort 2

EXPERIMENTAL

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

Drug: LS301-IT

LS301-IT Cohort 3

EXPERIMENTAL

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

Drug: LS301-IT

Interventions

LS301-IT DRUG

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.

LS301-IT Cohort -1; LS301-IT Cohort 1; LS301-IT Cohort 2; LS301-IT Cohort 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Integro Theranostics: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Robert Honigberg, MD

  Integro Theranostics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The pathologist evaluating the biopsy samples will be blinded as to patient participation in the study.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A single-dose, open-label, dose-escalation Phase 1b study in patients scheduled to undergo minimally invasive surgery (MIS) for known or suspected lung cancer via thoracoscopy (i.e., VATS). Single dose IV administration of LS301-IT, either on the day before surgery with 4 different doses in cohorts between 3 to 6 patients starting at a dose of 0.025 mg/kg with escalation or de-escalation. 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) in patients undergoing surgical thoracoscopy and VATS (Video-Assisted Thoracoscopic Surgery) resection of lung cancer. Safety is the primary objective of this study, followed by evaluation of the fluorescence signal as it relates to dose level and dosing time interval which will not be used for decision-making in the surgical resection in this study.

Study Record Dates

• First Submitted: November 19, 2024
• First Posted: December 3, 2024
• Study Start: November 7, 2024
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: December 2, 2025

Record last verified: 2025-12

Locations

US (1)