LS301-IT in Partial Mastectomy and Sentinel Lymph Node Biopsy (SLNB) for DCIS or Stage I-II Primary Invasive Breast Cancer

NCT05900986 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: LS301-IT-B101
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 9

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.

Conditions

Breast Cancer; DCIS; Invasive Duct Carcinoma of Breast

Outcome Measures

Primary Outcomes (8)

• 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

Study Arms (1)

LS301-IT

EXPERIMENTAL

LS301-IT will be administered by IV injection

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

Interventions

LS301-IT 0.025 mg/kg DRUG

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.

LS301-IT

LS301-IT 0.05 mg/kg DRUG

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.

LS301-IT

LS301-IT 0.075 mg/kg DRUG

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.

LS301-IT

LS301-IT 0.1 mg/kg DRUG

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.

LS301-IT

Eligibility Criteria

• Age: 18 Years - 80 Years
• Gender Eligibility Details: female with breast cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Integro Theranostics: lead

Study Sites (9)

Integro Theranostics Research Site #2

Scottsdale, Arizona, 85260, United States

Location

Integro Theranostics Research Site #12

Washington D.C., District of Columbia, 20059, United States

Location

Integro Theranostics Research Site #9

Weston, Florida, 33331, United States

Location

Integro Theranostics Research Site #6

The Bronx, New York, 10461, United States

Location

Integro Theranostics Clinical Research Site #8

Winston-Salem, North Carolina, 27103, United States

Location

Integro Theranostics Research Site #10

Cleveland, Ohio, 44195, United States

Location

Integro Theranostics Research Site #5

Philadelphia, Pennsylvania, 19107, United States

Location

Integro Theranostics Research Site #3

Dallas, Texas, 75290, United States

Location

Integro Theronostics Research Site #1

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Carcinoma, Intraductal, Noninfiltrating; Carcinoma, Ductal, Breast

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Breast Carcinoma In Situ; Carcinoma in Situ; Neoplasms, Ductal, Lobular, and Medullary; Carcinoma, Ductal

Study Officials

• Dan Thompson

  Integro Theranostics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2023
• First Posted: June 13, 2023
• Study Start: July 14, 2023
• Primary Completion: October 6, 2025
• Study Completion: May 1, 2026
• Last Updated: October 16, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)