UPCC 07123 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

Investigating Safety and Effectiveness of an Investigational Imaging Agent in Breast Cancer Surgery

Enrolling By Invitation
18 years - 80 years
Female
Phase 1/2
22 participants needed
1 Location

Brief description of study

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 of 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).

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Breast Cancer, DCIS, Invasive Duct Carcinoma of Breast
  • Age: 18 years - 80 years
  • Gender: Female

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.

This study investigates the safety and effectiveness of an investigational imaging agent in female patients who are undergoing surgery for ductal carcinoma in situ (DCIS) or early-stage breast cancer. The purpose of this study is to understand how the imaging agent works in the body and its potential to aid in visualizing tumor margins during surgery. The study focuses on patients undergoing partial mastectomy, which is a surgery to remove part of the breast tissue.

The study involves administering a single dose of the investigational imaging agent through an intravenous injection. Patients will be enrolled in different phases of the study, including a dose-finding phase and an expanded phase to determine the best dosing regimen. During surgery, surgeons may use the imaging results to make decisions about additional surgical actions. The study will observe the safety and efficacy of the imaging agent through these procedures.

  • Who can participate: The study is open to female patients with ductal carcinoma in situ (DCIS) or Stage I-II primary invasive breast cancer who are undergoing partial mastectomy, with or without sentinel lymph node biopsy. Participants should have an ECOG performance status of 0 to 2.
  • Study details: Participants will receive a single intravenous injection of the investigational imaging agent. The study will involve different phases, including a dose-finding phase and an expanded phase to determine the appropriate dosing schedule. The imaging agent will help surgeons visualize tumor margins during surgery.
Updated on 20 May 2026. Study ID: 23-0751
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