Trial Title:
LS301-IT in Partial Mastectomy and Sentinel Lymph Node Biopsy (SLNB) for DCIS or Stage I-II Primary Invasive Breast Cancer
NCT ID:
NCT05900986
Condition:
Breast Cancer
DCIS
Invasive Duct Carcinoma of Breast
Conditions: Official terms:
Carcinoma
Breast Neoplasms
Carcinoma, Ductal
Carcinoma, Ductal, Breast
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
LS301-IT 0.025 mg/kg
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.
Arm group label:
LS301-IT
Intervention type:
Drug
Intervention name:
LS301-IT 0.05 mg/kg
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.
Arm group label:
LS301-IT
Intervention type:
Drug
Intervention name:
LS301-IT 0.075 mg/kg
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.
Arm group label:
LS301-IT
Intervention type:
Drug
Intervention name:
LS301-IT 0.1 mg/kg
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.
Arm group label:
LS301-IT
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).
Criteria for 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.
Gender:
Female
Gender based:
Yes
Gender description:
female with breast cancer
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Integro Theranostics Research Site #2
Address:
City:
Scottsdale
Zip:
85260
Country:
United States
Status:
Active, not recruiting
Facility:
Name:
Integro Theranostics Research Site #12
Address:
City:
Washington
Zip:
20059
Country:
United States
Status:
Recruiting
Contact:
Phone:
314-325-1800
Email:
npeterson@kingdomcapital.com
Facility:
Name:
Integro Theranostics Research Site #9
Address:
City:
Weston
Zip:
33331
Country:
United States
Status:
Recruiting
Contact:
Last name:
Integro Study Line
Phone:
314-325-1800
Email:
npeterson@kingdomcapital.com
Facility:
Name:
Integro Theranostics Research Site #6
Address:
City:
Bronx
Zip:
10461
Country:
United States
Status:
Recruiting
Contact:
Last name:
Integro Study Line
Phone:
314-325-1800
Email:
npeterson@kingdomcapital.com
Facility:
Name:
Integro Theranostics Clinical Research Site #8
Address:
City:
Winston-Salem
Zip:
27103
Country:
United States
Status:
Active, not recruiting
Facility:
Name:
Integro Theranostics Research Site #10
Address:
City:
Cleveland
Zip:
44195
Country:
United States
Status:
Active, not recruiting
Facility:
Name:
Integro Theranostics Research Site #5
Address:
City:
Philadelphia
Zip:
19107
Country:
United States
Status:
Recruiting
Contact:
Last name:
Integro Study LIne
Phone:
314-325-1800
Email:
npeterson@kingdomcapital.com
Facility:
Name:
Integro Theranostics Research Site #3
Address:
City:
Dallas
Zip:
75290
Country:
United States
Status:
Recruiting
Contact:
Last name:
Integro Study Line
Phone:
314-325-1800
Email:
npeterson@kingdomcapital.com
Facility:
Name:
Integro Theronostics Research Site #1
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Active, not recruiting
Start date:
July 14, 2023
Completion date:
July 2025
Lead sponsor:
Agency:
Integro Theranostics
Agency class:
Industry
Source:
Integro Theranostics
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05900986
