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

Integro Theranostics9 sites in 1 country100 target enrollmentJuly 14, 2023

ConditionsBreast Cancer DCIS Invasive Duct Carcinoma of Breast

InterventionsLS301-IT 0.025 mg/kg LS301-IT 0.05 mg/kg LS301-IT 0.075 mg/kg LS301-IT 0.1 mg/kg

DrugsLS301-IT 0.025 mg/kg LS301-IT 0.05 mg/kg LS301-IT 0.075 mg/kg LS301-IT 0.1 mg/kg

Overview

Phase: Phase 1
Intervention: LS301-IT 0.025 mg/kg
Conditions: Breast Cancer
Sponsor: Integro Theranostics
Enrollment: 100
Locations: 9
Primary Endpoint: Adverse Events
Status: Active, not recruiting
Last Updated: 6 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Detailed Description

This is a Phase 1b/Phase 2, 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 SLNs in female patients with DCIS or Stage I-II, primary invasive carcinoma of the breast, for which the patient's primary surgical treatment is partial mastectomy. Eligible patients will be enrolled into either: * Phase 1b (Period 1): dose finding (escalation/de-escalation), and dose timing adjustment; * Phase 2a (Period 2): expanded sample size based on acceptable dosing regimen, that being the dose level(s) and time interval between LS301-IT injection and surgery, determined in Period 1; or * Period 2b (Period 3): allow surgeon to make additional surgical decisions based on fluorescence imaging findings during surgery (Period 3 will not be opened until results are available from Periods 1 and 2 and further FDA consultation is obtained).

Registry

clinicaltrials.gov

Start Date

July 14, 2023

End Date

May 1, 2026

Last Updated

6 months ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Integro Theranostics

Responsible Party

Sponsor

Eligibility Criteria

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
•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.