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

Primary Purpose

Breast Cancer, DCIS, Invasive Duct Carcinoma of Breast

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
LS301-IT 0.025 mg/kg
LS301-IT 0.05 mg/kg
LS301-IT 0.075 mg/kg
LS301-IT 0.1 mg/kg
Sponsored by
Integro Theranostics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Integro Theranostics Research Site #2
  • Integro Theranostics Research Site #6Recruiting
  • Integro Theranostics Clinical Research Site #8Recruiting
  • Integro Theranostics Research Site #5Recruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

LS301-IT

Arm Description

LS301-IT will be adminstered by IV injection

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
May 10, 2023
Last Updated
September 20, 2023
Sponsor
Integro Theranostics
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1. Study Identification

Unique Protocol Identification Number
NCT05900986
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 14, 2023 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Integro Theranostics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, DCIS, Invasive Duct Carcinoma of Breast

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
LS301-IT
Arm Type
Experimental
Arm Description
LS301-IT will be adminstered by IV injection
Intervention Type
Drug
Intervention Name(s)
LS301-IT 0.025 mg/kg
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
LS301-IT 0.05 mg/kg
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
LS301-IT 0.075 mg/kg
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
LS301-IT 0.1 mg/kg
Intervention Description
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.
Primary Outcome Measure Information:
Title
Adverse Events
Description
Number of participants with treatment-related adverse events
Time Frame
30 days
Title
Pharmacodynamics
Description
Tumor to non-tumor ratio fluorescence response
Time Frame
during surgery
Title
Pharmacodynamics
Description
Surgeon's assessment using a semi-quantitative scoring system of fluorescence compared with intraoperative and postoperative pathology assessments.
Time Frame
During surgery
Title
Cmax
Description
maximum observed plasma concentration main metabolite in plasma.
Time Frame
24 hours
Title
AUCinf
Description
area under the plasma concentration time curve from time 0 extrapolated to infinite time
Time Frame
24 hours
Title
AUClast
Description
area under the plasma concentration-time curve from time 0 to the last quantifiable plasma concentration
Time Frame
24 hours
Title
Tmax
Description
time to reach maximal plasma concentration (Tmax)
Time Frame
24 hours
Title
t1/2
Description
elimination/apparent terminal elimination half life
Time Frame
24 hours

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
female with breast cancer
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nicole Peterson
Phone
314-325-1800
Email
npeterson@kingdomcapital.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dan Thompson
Organizational Affiliation
Integro Theranostics
Official's Role
Study Director
Facility Information:
Facility Name
Integro Theranostics Research Site #2
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Integro Study Line
Phone
314-325-1800
Email
npeterson@kingdomcapital.com
Facility Name
Integro Theranostics Research Site #6
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Integro Study Line
Phone
314-325-1800
Email
npeterson@kingdomcapital.com
Facility Name
Integro Theranostics Clinical Research Site #8
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Integro Study LIne
Phone
314-325-1800
Email
npeterson@kingdomcapital.com
Facility Name
Integro Theranostics Research Site #5
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Integro Study LIne
Phone
314-325-1800
Email
npeterson@kingdomcapital.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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