LS301-IT in Partial Mastectomy and Sentinel Lymph Node Biopsy (SLNB) for DCIS or Stage I-II Primary Invasive Breast Cancer
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1/Phase 2 |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: LS301-IT LS301-IT will be adminstered by IV injection |
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.
Drug: 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.
Drug: 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.
Drug: 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.
|
Outcome Measures
Primary Outcome Measures
- Adverse Events [30 days]
Number of participants with treatment-related adverse events
- Pharmacodynamics [during surgery]
Tumor to non-tumor ratio fluorescence response
- Pharmacodynamics [During surgery]
Surgeon's assessment using a semi-quantitative scoring system of fluorescence compared with intraoperative and postoperative pathology assessments.
- Cmax [24 hours]
maximum observed plasma concentration main metabolite in plasma.
- AUCinf [24 hours]
area under the plasma concentration time curve from time 0 extrapolated to infinite time
- AUClast [24 hours]
area under the plasma concentration-time curve from time 0 to the last quantifiable plasma concentration
- Tmax [24 hours]
time to reach maximal plasma concentration (Tmax)
- t1/2 [24 hours]
elimination/apparent terminal elimination half life
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Integro Theranostics Research Site #1 | Scottsdale | Arizona | United States | 85258 |
Sponsors and Collaborators
- Integro Theranostics
Investigators
- Study Director: Dan Thompson, Integro Theranostics
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- LS301-IT-B101