LS301-IT in Partial Mastectomy and Sentinel Lymph Node Biopsy (SLNB) for DCIS or Stage I-II Primary Invasive Breast Cancer
LS301-IT-B101 (primary)
NCI-2023-06503
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.
Objectives
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
- 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
Treatment Sites in Georgia
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