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.
Additional locations may be listed on ClinicalTrials.gov for NCT05900986.
See trial information on ClinicalTrials.gov for a list of participating sites.
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).
Lead OrganizationIntegro Theranostics
Principal InvestigatorDan Thompson
