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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer; DCIS; Invasive Duct Carcinoma of Breast
• Intervention / Treatment: 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

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).

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85260
      • Integro Theranostics Research Site #2
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20059
      • Integro Theranostics Research Site #12
  • Florida
    • Weston, Florida, United States, 33331
      • Integro Theranostics Research Site #9
  • New York
    • The Bronx, New York, United States, 10461
      • Integro Theranostics Research Site #6
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27103
      • Integro Theranostics Clinical Research Site #8
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Integro Theranostics Research Site #10
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Integro Theranostics Research Site #5
  • Texas
    • Dallas, Texas, United States, 75290
      • Integro Theranostics Research Site #3
    • Houston, Texas, United States, 77030
      • Integro Theronostics Research Site #1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: LS301-IT; LS301-IT will be administered by IV injection

Drug: LS301-IT 0.025 mg/kg; The dose of LS301-IT planned to be administered to the first cohort of patients is 0.025 mg/kg. Depending on the results the dose for subsequent cohorts will be increased to 0.05, 0.075, and 0.1 mg/kg; the dose may also be decreased (by 50% as necessary). The optimal dose determined in Periods 1 and 2 will be administered to patients in Period 3.; Drug: LS301-IT 0.05 mg/kg; Depending on the results the dose for subsequent cohorts will be increased to 0.05, 0.075, and 0.1 mg/kg; the dose may also be decreased. The optimal dose determined in Periods 1 and 2 will be administered to patients in Period 3.; Drug: LS301-IT 0.075 mg/kg; Depending on the results the dose for subsequent cohorts will be increased to 0.05, 0.075, and 0.1 mg/kg; the dose may also be decreased. The optimal dose determined in Periods 1 and 2 will be administered to patients in Period 3.; Drug: LS301-IT 0.1 mg/kg; Depending on the results the dose for subsequent cohorts will be increased to 0.05, 0.075, and 0.1 mg/kg; the dose may also be decreased. The optimal dose determined in Periods 1 and 2 will be administered to patients in Period 3.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events	Number of participants with treatment-related adverse events	30 days
Pharmacodynamics	Tumor to non-tumor ratio fluorescence response	during surgery
Pharmacodynamics	Surgeon's assessment using a semi-quantitative scoring system of fluorescence compared with intraoperative and postoperative pathology assessments.	During surgery
Cmax	maximum observed plasma concentration main metabolite in plasma.	24 hours
AUCinf	area under the plasma concentration time curve from time 0 extrapolated to infinite time	24 hours
AUClast	area under the plasma concentration-time curve from time 0 to the last quantifiable plasma concentration	24 hours
Tmax	time to reach maximal plasma concentration (Tmax)	24 hours
t1/2	elimination/apparent terminal elimination half life	24 hours

Collaborators and Investigators

• Sponsor: Integro Theranostics
• Investigators: Study Director: Dan Thompson, Integro Theranostics

Study record dates

Study Major Dates

• Study Start (Actual): July 14, 2023
• Primary Completion (Actual): October 6, 2025
• Study Completion (Actual): May 6, 2026

Study Registration Dates

• First Submitted: May 10, 2023
• First Submitted That Met QC Criteria: June 2, 2023
• First Posted (Actual): June 13, 2023

Study Record Updates

• Last Update Posted (Actual): May 20, 2026
• Last Update Submitted That Met QC Criteria: May 18, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Breast Carcinoma In Situ; Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Skin Diseases; Breast Diseases; Carcinoma; Neoplasms, Ductal, Lobular, and Medullary; Carcinoma in Situ; Carcinoma, Ductal; Skin and Connective Tissue Diseases; Breast Neoplasms; Carcinoma, Intraductal, Noninfiltrating; Carcinoma, Ductal, Breast
• Other Study ID Numbers: LS301-IT-B101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No