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Completed

NCT Number: NCT05900986

LS301-IT in Partial Mastectomy and Sentinel Lymph Node Biopsy (SLNB) for 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.

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Key information

Conditions

Breast Cancer Adenocarcinoma Breast Carcinoma In Situ Breast Diseases Breast Neoplasms Carcinoma Carcinoma in Situ Carcinoma, Ductal Carcinoma, Ductal, Breast Carcinoma, Intraductal, Noninfiltrating DCIS Invasive Duct Carcinoma of Breast Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Ductal, Lobular, and Medullary Neoplasms, Glandular and Epithelial Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Integro Theranostics Research Site #2, Scottsdale, Arizona, United States

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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 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 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 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.

Primary outcomes

  1. Adverse Events

    Time frame: 30 days

    Number of participants with treatment-related adverse events

  2. Pharmacodynamics

    Time frame: during surgery

    Tumor to non-tumor ratio fluorescence response

  3. Pharmacodynamics

    Time frame: During surgery

    Surgeon's assessment using a semi-quantitative scoring system of fluorescence compared with intraoperative and postoperative pathology assessments.

  4. Cmax

    Time frame: 24 hours

    maximum observed plasma concentration main metabolite in plasma.

  5. AUCinf

    Time frame: 24 hours

    area under the plasma concentration time curve from time 0 extrapolated to infinite time

  6. AUClast

    Time frame: 24 hours

    area under the plasma concentration-time curve from time 0 to the last quantifiable plasma concentration

  7. Tmax

    Time frame: 24 hours

    time to reach maximal plasma concentration (Tmax)

  8. t1/2

    Time frame: 24 hours

    elimination/apparent terminal elimination half life

Sponsors and collaborators

Lead sponsor

Integro Theranostics

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Jun 13, 2023
Registry last updated
May 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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