LS301-IT in Partial Mastectomy and Sentinel Lymph Node Biopsy (SLNB) for DCIS or Stage I-II Primary Invasive Breast Cancer

Active:	Yes
Cancer Type:	Breast Cancer	NCT ID:	NCT05900986
Trial Phases:	Phase I Phase II	Protocol IDs:	LS301-IT-B101 (primary) NCI-2023-06503
Eligibility:	18 - 80 Years, Female	Study Type:	Treatment
Study Sponsor:	Integro Theranostics
NCI Full Details:	http://clinicaltrials.gov/show/NCT05900986

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).

Treatment Sites in Georgia

City of Hope Atlanta
600 Celebrate Life Parkway
Newnan, GA 30265
770-400-6169
www.cityofhope.org/locations/atlanta/atlanta-cancer-center

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