LS301-IT in Partial Mastectomy and Sentinel Lymph Node Biopsy (SLNB) for DCIS or Stage I-II Primary Invasive Breast Cancer
- Conditions
- Breast CancerDCISInvasive Duct Carcinoma of Breast
- Interventions
- Drug: LS301-IT 0.025 mg/kgDrug: LS301-IT 0.05 mg/kgDrug: LS301-IT 0.075 mg/kgDrug: LS301-IT 0.1 mg/kg
- Registration Number
- NCT05900986
- Lead Sponsor
- Integro Theranostics
- 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).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 100
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description LS301-IT LS301-IT 0.025 mg/kg LS301-IT will be administered by IV injection LS301-IT LS301-IT 0.05 mg/kg LS301-IT will be administered by IV injection LS301-IT LS301-IT 0.075 mg/kg LS301-IT will be administered by IV injection LS301-IT LS301-IT 0.1 mg/kg LS301-IT will be administered by IV injection
- Primary Outcome Measures
Name Time Method Adverse Events 30 days Number of participants with treatment-related adverse events
AUCinf 24 hours area under the plasma concentration time curve from time 0 extrapolated to infinite time
Pharmacodynamics During surgery Surgeon's assessment using a semi-quantitative scoring system of fluorescence compared with intraoperative and postoperative pathology assessments.
Cmax 24 hours maximum observed plasma concentration main metabolite in plasma.
AUClast 24 hours area under the plasma concentration-time curve from time 0 to the last quantifiable plasma concentration
Tmax 24 hours time to reach maximal plasma concentration (Tmax)
t1/2 24 hours elimination/apparent terminal elimination half life
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (9)
Integro Theranostics Research Site #2
🇺🇸Scottsdale, Arizona, United States
Integro Theranostics Research Site #12
🇺🇸Washington, District of Columbia, United States
Integro Theranostics Research Site #9
🇺🇸Weston, Florida, United States
Integro Theranostics Research Site #6
🇺🇸Bronx, New York, United States
Integro Theranostics Clinical Research Site #8
🇺🇸Winston-Salem, North Carolina, United States
Integro Theranostics Research Site #10
🇺🇸Cleveland, Ohio, United States
Integro Theranostics Research Site #5
🇺🇸Philadelphia, Pennsylvania, United States
Integro Theranostics Research Site #3
🇺🇸Dallas, Texas, United States
Integro Theronostics Research Site #1
🇺🇸Houston, Texas, United States