Clinical trial · Interventional
LS301-IT in Partial Mastectomy and Sentinel Lymph Node Biopsy (SLNB) for DCIS or Stage I-II Primary Invasive Breast Cancer
An Open-label, Single-arm, Phase 1b/2 Study to Investigate the Safety, Efficacy and Pharmacokinetics of LS301-IT in Female Patients Undergoing Partial Mastectomy and Sentinel Lymph Node Biopsy (SLNB) for Ductal Carcinoma in Situ (DCIS) or Stage I-II Primary Invasive Breast 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/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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| DCIS | Breast Ductal Carcinoma In Situ | ALIAS | 0.90 |
| Invasive Duct Carcinoma of Breast | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LS301-IT 0.025 mg/kg | Drug | — | UNRESOLVED |
| LS301-IT 0.05 mg/kg | Drug | — | UNRESOLVED |
| LS301-IT 0.075 mg/kg | Drug | — | UNRESOLVED |
| LS301-IT 0.1 mg/kg | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- LS301-IT
- description
- LS301-IT will be administered by IV injection
- interventionNames
- Drug: LS301-IT 0.025 mg/kg
- Drug: LS301-IT 0.05 mg/kg
- Drug: LS301-IT 0.075 mg/kg
- Drug: LS301-IT 0.1 mg/kg
Primary outcomes (8)
- measure
- Adverse Events
- timeFrame
- 30 days
- description
- Number of participants with treatment-related adverse events
- measure
- Pharmacodynamics
- timeFrame
- during surgery
- description
- Tumor to non-tumor ratio fluorescence response
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * DCIS (whether or not undergoing planned SLNB) or patients with Stage I-II, primary invasive carcinoma of the breast undergoing SLNB for which the patient's primary surgical treatment is single breast partial mastectomy. * ECOG performance status of 0 to 2 Exclusion Criteria: * Contraindications for surgery. * Simultaneous bilateral lumpectomies and bilateral partial mastectomies. * History of drug-related anaphylactic reactions, including those attributed to indocyanine green (ICG) or other agents used in the study * Prior chemotherapy, endocrine therapy, or biologic therapy for current clinically or biopsy proven breast cancer for Period 1. * Open surgery in the ipsilateral breast within a period of 1 year before administration of LS301-IT. * History of radiation therapy to the chest. * The lymphatic imaging agent ICG cannot be used prior to the partial mastectomy and SLNB procedures on the day of surgery.
References
Publications (0)
Data not yet available