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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05900986
• Other study ID #: LS301-IT-B101
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: July 14, 2023
• Est. completion date: June 2024

Study information

• Verified date: February 2024
• Source: Integro Theranostics
• Contact: Nicole Peterson
• Phone: 314-325-1800
• Email: npeterson[@]kingdomcapital.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Carcinoma
• Carcinoma, Ductal
• Carcinoma, Ductal, Breast
• DCIS
• Invasive Duct Carcinoma of Breast

Intervention

Drug:
• 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

Country	Name	City	State
United States	Integro Theranostics Research Site #6	Bronx	New York
United States	Integro Theranostics Research Site #10	Cleveland	Ohio
United States	Integro Theranostics Research Site #3	Dallas	Texas
United States	Integro Theronostics Research Site #1	Houston	Texas
United States	Integro Theranostics Research Site #5	Philadelphia	Pennsylvania
United States	Integro Theranostics Research Site #2	Scottsdale	Arizona
United States	Integro Theranostics Research Site #9	Weston	Florida
United States	Integro Theranostics Clinical Research Site #8	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Integro Theranostics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Events	Number of participants with treatment-related adverse events	30 days
Primary	Pharmacodynamics	Tumor to non-tumor ratio fluorescence response	during surgery
Primary	Pharmacodynamics	Surgeon's assessment using a semi-quantitative scoring system of fluorescence compared with intraoperative and postoperative pathology assessments.	During surgery
Primary	Cmax	maximum observed plasma concentration main metabolite in plasma.	24 hours
Primary	AUCinf	area under the plasma concentration time curve from time 0 extrapolated to infinite time	24 hours
Primary	AUClast	area under the plasma concentration-time curve from time 0 to the last quantifiable plasma concentration	24 hours
Primary	Tmax	time to reach maximal plasma concentration (Tmax)	24 hours
Primary	t1/2	elimination/apparent terminal elimination half life	24 hours