Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancers | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LS301-IT | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- LS301-IT Cohort -1
- description
- 0.0125 mg/kg LS301-IT administered by IV infusion over approximately 15 minutes the day before surgery
- interventionNames
- Drug: LS301-IT
- type
- EXPERIMENTAL
- label
- LS301-IT Cohort 1
- description
- 0.025 mg/kg LS301-IT administered by IV infusion over approximately 15 minutes the day before surgery
- interventionNames
- Drug: LS301-IT
- type
- EXPERIMENTAL
- label
- LS301-IT Cohort 2
- description
- 0.05 mg/kg LS301-IT administered by IV infusion over approximately 15 minutes the day before surgery
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available