- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05900986
LS301-IT in Partial Mastectomy and Sentinel Lymph Node Biopsy (SLNB) for DCIS or Stage I-II Primary Invasive Breast Cancer
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 Overview
Status
Conditions
Intervention / Treatment
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).
Study Type
Enrollment (Estimated)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Contact
- Name: Nicole Peterson
- Phone Number: 314-325-1800
- Email: npeterson@kingdomcapital.com
Study Locations
-
-
Arizona
-
Scottsdale, Arizona, United States, 85260
- Recruiting
- Integro Theranostics Research Site #2
-
Contact:
- Integro Study Line
- Phone Number: 314-325-1800
- Email: npeterson@kingdomcapital.com
-
-
Florida
-
Weston, Florida, United States, 33331
- Recruiting
- Integro Theranostics Research Site #9
-
Contact:
- Integro Study Line
- Phone Number: 314-325-1800
- Email: npeterson@kingdomcapital.com
-
-
New York
-
Bronx, New York, United States, 10461
- Recruiting
- Integro Theranostics Research Site #6
-
Contact:
- Integro Study Line
- Phone Number: 314-325-1800
- Email: npeterson@kingdomcapital.com
-
-
North Carolina
-
Winston-Salem, North Carolina, United States, 27103
- Recruiting
- Integro Theranostics Clinical Research Site #8
-
Contact:
- Integro Study Line
- Phone Number: 314-325-1800
- Email: npeterson@kingdomcapital.com
-
-
Ohio
-
Cleveland, Ohio, United States, 44195
- Recruiting
- Integro Theranostics Research Site #10
-
Contact:
- Integro Study Line
- Phone Number: 314-325-1800
- Email: npeterson@kingdomcapital.com
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19107
- Recruiting
- Integro Theranostics Research Site #5
-
Contact:
- Integro Study Line
- Phone Number: 314-325-1800
- Email: npeterson@kingdomcapital.com
-
-
Texas
-
Dallas, Texas, United States, 75290
- Recruiting
- Integro Theranostics Research Site #3
-
Contact:
- Integro Study Line
- Phone Number: 314-325-1800
- Email: npeterson@kingdomcapital.com
-
Houston, Texas, United States, 77030
- Recruiting
- Integro Theronostics Research Site #1
-
Contact:
- Integro Study Line
- Phone Number: 314-325-1800
- Email: npeterson@kingdomcapital.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: LS301-IT
LS301-IT will be adminstered by IV injection
|
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.
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.
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse Events
Time Frame: 30 days
|
Number of participants with treatment-related adverse events
|
30 days
|
Pharmacodynamics
Time Frame: during surgery
|
Tumor to non-tumor ratio fluorescence response
|
during surgery
|
Pharmacodynamics
Time Frame: During surgery
|
Surgeon's assessment using a semi-quantitative scoring system of fluorescence compared with intraoperative and postoperative pathology assessments.
|
During surgery
|
Cmax
Time Frame: 24 hours
|
maximum observed plasma concentration main metabolite in plasma.
|
24 hours
|
AUCinf
Time Frame: 24 hours
|
area under the plasma concentration time curve from time 0 extrapolated to infinite time
|
24 hours
|
AUClast
Time Frame: 24 hours
|
area under the plasma concentration-time curve from time 0 to the last quantifiable plasma concentration
|
24 hours
|
Tmax
Time Frame: 24 hours
|
time to reach maximal plasma concentration (Tmax)
|
24 hours
|
t1/2
Time Frame: 24 hours
|
elimination/apparent terminal elimination half life
|
24 hours
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Dan Thompson, Integro Theranostics
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LS301-IT-B101
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Breast Cancer
-
Northwestern UniversityEisai Inc.UnknownMale Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative...United States
-
Rutgers, The State University of New JerseyNational Cancer Institute (NCI); Rutgers Cancer Institute of New JerseyActive, not recruitingStage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative Breast CancerUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedMale Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
-
University of WashingtonTerminatedBreast Cancer | Breast Cancer Stage I | Breast Cancer Stage II | Breast Cancer Stage III | Breast Cancer Stage IIB | Breast Cancer Stage IIA | Breast Cancer Stage IIIA | Breast Cancer Stage IIIB | Breast Cancer Stage IIIcUnited States
-
CelgeneCompletedBreast Cancer | Metastatic Breast Cancer | Stage IV Breast Cancer | Triple-negative Breast Cancer | Recurrent Breast Cancer | Breast Tumor | Cancer of the Breast | Triple-negative Metastatic Breast Cancer | Estrogen Receptor- Negative Breast Cancer | HER2- Negative Breast Cancer | Progesterone Receptor- Negative...United States, United Kingdom, Italy, Germany, Spain, Canada, Portugal, Australia, Austria, Greece, Brazil, France
-
University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedHER2-positive Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
-
University of WashingtonNational Cancer Institute (NCI)CompletedHER2-positive Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Estrogen Receptor-negative Breast Cancer | Estrogen Receptor-positive Breast Cancer | Progesterone Receptor-negative Breast Cancer | Progesterone Receptor-positive Breast...United States
-
University of WashingtonNational Cancer Institute (NCI)CompletedHER2-positive Breast Cancer | Male Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
-
Sidney Kimmel Cancer Center at Thomas Jefferson...Susan G. Komen Breast Cancer FoundationCompletedStage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative Breast CancerUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI)WithdrawnStage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast Cancer
Clinical Trials on LS301-IT 0.025 mg/kg
-
ShireCompleted
-
ShireCompletedShort Bowel SyndromeUnited States, Canada, Finland, Belgium, Italy, United Kingdom, Germany
-
Merck Sharp & Dohme LLCCompleted
-
Keymed Biosciences Co.LtdNot yet recruitingSystemic Lupus Erythematosus
-
GlaxoSmithKlineCompletedMuscular DystrophiesFrance, United States
-
MedImmune LLCCompletedHealthy SubjectsUnited States
-
Healthgen Biotechnology Corp.RecruitingEmphysema Secondary to Congenital AATDUnited States
-
Gangnam Severance HospitalCompleted
-
Aileron Therapeutics, Inc.Completed
-
Crucell Holland BVNational Institute of Allergy and Infectious Diseases (NIAID)Completed