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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 18
- 主要终点
- Adverse Events
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •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.
研究组 & 干预措施
LS301-IT
LS301-IT will be administered by IV injection
干预措施: LS301-IT 0.025 mg/kg (Drug)
LS301-IT
LS301-IT will be administered by IV injection
干预措施: LS301-IT 0.05 mg/kg (Drug)
LS301-IT
LS301-IT will be administered by IV injection
干预措施: LS301-IT 0.075 mg/kg (Drug)
LS301-IT
LS301-IT will be administered by IV injection
干预措施: LS301-IT 0.1 mg/kg (Drug)
结局指标
主要结局
Adverse Events
时间窗: 30 days
Number of participants with treatment-related adverse events
Pharmacodynamics
时间窗: During surgery
Surgeon's assessment using a semi-quantitative scoring system of fluorescence compared with intraoperative and postoperative pathology assessments.
Cmax
时间窗: 24 hours
maximum observed plasma concentration main metabolite in plasma.
AUCinf
时间窗: 24 hours
area under the plasma concentration time curve from time 0 extrapolated to infinite time
AUClast
时间窗: 24 hours
area under the plasma concentration-time curve from time 0 to the last quantifiable plasma concentration
Tmax
时间窗: 24 hours
time to reach maximal plasma concentration (Tmax)
t1/2
时间窗: 24 hours
elimination/apparent terminal elimination half life
次要结局
未报告次要终点