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.
Brief Title
LS301-IT in Partial Mastectomy and Sentinel Lymph Node Biopsy (SLNB) for DCIS or Stage I-II Primary Invasive Breast Cancer
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).
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).
Categories
Central Contacts
Central Contact Role
Contact
Central Contact Phone
314-325-1800
Central Contact Email
npeterson@kingdomcapital.com
Completion Date
Completion Date Type
Estimated
Conditions
Breast Cancer
DCIS
Invasive Duct Carcinoma of Breast
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.
* 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.
Inclusion 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
* 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
Gender
Female
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
80 Years
Minimum Age
18 Years
NCT Id
NCT05900986
Org Class
Industry
Org Full Name
Integro Theranostics
Org Study Id
LS301-IT-B101
Overall Status
Recruiting
Phases
Phase 1
Phase 2
Primary Completion Date
Primary Completion Date Type
Estimated
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
Primary Outcomes
Outcome Description
Number of participants with treatment-related adverse events
Outcome Measure
Adverse Events
Outcome Time Frame
30 days
Outcome Description
Tumor to non-tumor ratio fluorescence response
Outcome Measure
Pharmacodynamics
Outcome Time Frame
during surgery
Outcome Description
Surgeon's assessment using a semi-quantitative scoring system of fluorescence compared with intraoperative and postoperative pathology assessments.
Outcome Measure
Pharmacodynamics
Outcome Time Frame
During surgery
Outcome Description
maximum observed plasma concentration main metabolite in plasma.
Outcome Measure
Cmax
Outcome Time Frame
24 hours
Outcome Description
area under the plasma concentration time curve from time 0 extrapolated to infinite time
Outcome Measure
AUCinf
Outcome Time Frame
24 hours
Outcome Description
area under the plasma concentration-time curve from time 0 to the last quantifiable plasma concentration
Outcome Measure
AUClast
Outcome Time Frame
24 hours
Outcome Description
time to reach maximal plasma concentration (Tmax)
Outcome Measure
Tmax
Outcome Time Frame
24 hours
Outcome Description
elimination/apparent terminal elimination half life
Outcome Measure
t1/2
Outcome Time Frame
24 hours
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
80
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Sheldon Feldman
Investigator Email
sfeldman@montefiore.org