Clinical trial NCT06713564: A Single Dose, Open-Label, Dose-escalation Study of the Safety and Imaging Characteristics of LS301-IT for Intraoperative Imaging of Lung Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Lung Cancers
Keywords: lung cancer imaging
lung cancer surgery
Lead sponsor: Integro Theranostics
Sponsor class: INDUSTRY
First posted: 2024-12-03
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Patients with Dose Limiting Toxicities
timeFrame: 2 to 7 days after dosing
measure: Number of Patients that discontinue the study or have their surgery cancelled due to toxicity
timeFrame: From start of dosing to time of surgery
Secondary outcomes:
Other outcomes:
measure: Maximum observed plasma concentration (Cmax) in ng/mL
timeFrame: Samples collected up to 24 hours after dosing
measure: Area under the plasma concentration time curve from time 0 extrapolated to infinite time (AUC0-∞ [AUCinf]) in ng*hr/mL
timeFrame: Over 24 hours after dosing
measure: Area under the plasma concentration-time curve from time 0 to the last quantifiable plasma concentration (AUC0-t [AUClast]) in ng*hr/mL
timeFrame: over 24 hours after dosing
measure: Time to reach maximal plasma concentration (Tmax) in minutes
timeFrame: over 24 hours after dosing
measure: Elimination/apparent terminal elimination half- life (t1/2) in minutes
timeFrame: 24 hours after dosing
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Integro Theranostics
name: Robert Honigberg, MD
role: STUDY_DIRECTOR
References: