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LS301-IT in Partial Mastectomy and Sentinel Lymph Node Biopsy (SLNB) for DCIS or Stage I-II Primary Invasive Breast Cancer
Sponsor: Integro Theranostics
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.
Official 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
Key Details
Gender
FEMALE
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2023-07-14
Completion Date
2026-05
Last Updated
2025-10-16
Healthy Volunteers
No
Interventions
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.
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.
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.
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.
Locations (9)
Integro Theranostics Research Site #2
Scottsdale, Arizona, United States
Integro Theranostics Research Site #12
Washington D.C., District of Columbia, United States
Integro Theranostics Research Site #9
Weston, Florida, United States
Integro Theranostics Research Site #6
The 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