drugset / Trial / NCT05900986
LS301-IT in Partial Mastectomy and Sentinel Lymph Node Biopsy (SLNB) for DCIS or Stage I-II Primary Invasive Breast Cancer
NaSingle-groupOpen-labelTreatment
Summary
The aim of this Phase 1b/2 study is to investigate the safety, efficacy, and pharmacokinetics (PK) of a single dose of LS301-IT, a novel fluorescence imaging agent developed by Integro Theranostics (IT), administered by intravenous (IV) injection in female patients undergoing partial mastectomy for DCIS (whether or not undergoing planned SLNB) or Stage I-II primary invasive breast cancer undergoing SLNB. Safety is the primary objective of this study, followed by efficacy that will be assessed from fluorescence imaging observations and data.
Timeline
- Start
- 2023-07-14
- Primary completion
- 2025-10-06
- Completion
- 2026-05-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | LS301-IT | Diagnostic / imaging agent | 0.025 mg/kg | Intravenous |
| Subject | LS301-IT | Diagnostic / imaging agent | 0.05 mg/kg | Intravenous |
| Subject | LS301-IT | Diagnostic / imaging agent | 0.075 mg/kg | Intravenous |
| Subject | LS301-IT | Diagnostic / imaging agent | 0.1 mg/kg | Intravenous |