Clinical trial NCT05900986: LS301-IT in Partial Mastectomy and Sentinel Lymph Node Biopsy (SLNB) for DCIS or Stage I-II Primary Invasive Breast Cancer
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Breast Cancer
DCIS
Invasive Duct Carcinoma of Breast
Lead sponsor: Integro Theranostics
Sponsor class: INDUSTRY
First posted: 2023-06-13
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Adverse Events
timeFrame: 30 days
measure: Pharmacodynamics
timeFrame: during surgery
measure: Pharmacodynamics
timeFrame: During surgery
measure: Cmax
timeFrame: 24 hours
measure: AUCinf
timeFrame: 24 hours
measure: AUClast
timeFrame: 24 hours
measure: Tmax
timeFrame: 24 hours
measure: t1/2
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Integro Theranostics Research Site #2
state: Arizona
city: Washington
country: United States
facility: Integro Theranostics Research Site #12
state: District of Columbia
city: Weston
country: United States
facility: Integro Theranostics Research Site #9
state: Florida
city: Bronx
country: United States
facility: Integro Theranostics Research Site #6
state: New York
city: Winston-Salem
country: United States
facility: Integro Theranostics Clinical Research Site #8
state: North Carolina
city: Cleveland
country: United States
facility: Integro Theranostics Research Site #10
state: Ohio
city: Philadelphia
country: United States
facility: Integro Theranostics Research Site #5
state: Pennsylvania
city: Dallas
country: United States
facility: Integro Theranostics Research Site #3
state: Texas
city: Houston
country: United States
facility: Integro Theronostics Research Site #1
state: Texas
Study officials:
affiliation: Integro Theranostics
name: Dan Thompson
role: STUDY_DIRECTOR
References: