NCT03316794终止1 期
An Open-Label Study of SC-005 in Subjects With Triple Negative Breast Cancer (TNBC)
AbbVie8 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2018年1月4日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 2
- 试验地点
- 8
- 主要终点
- Number of Participants with Dose-limiting Toxicities (DLTs)
研究概览
简要总结
This is a multicenter, open-label study in participants with triple negative breast cancer (TNBC) to study the safety, tolerability, pharmacokinetics and preliminary efficacy of SC-005. This study consists of 2 parts: Part A (dose regimen finding) followed by Part B (dose expansion).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed advanced TNBC that is relapsed, refractory, or progressive and not eligible for another standard therapy that would confer clinical benefit to the subject.
- •Advanced disease is defined as metastatic disease or locally advanced disease that is not amenable to surgery or radiotherapy with curative intent
- •TNBC is defined as:
- •<1% staining by immunohistochemistry (IHC) for estrogen (ER) and progesterone (PR) receptors, 0 or 1+ IHC for human epidermal growth factor receptor 2 (HER2), OR
- •Negative for HER2 amplification by in situ hybridization (ISH) for 2+ IHC disease.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •Adequate hematologic, hepatic, and renal function.
排除标准
- •Any significant medical condition including any suggested by Screening laboratory findings that, in the opinion of the Investigator or Sponsor, may place the subject at undue risk from the study.
- •Has ECG abnormalities that make QT interval corrected (QTc) evaluation difficult (e.g., severe morphologic abnormalities).
- •Prior exposure to a pyrrolobenzodiazepine or indolino-benzodiazepine based drug, or known hypersensitivity or contraindication to SC-005 or excipient contained in the drug formulation.
研究组 & 干预措施
SC-005
Experimental
SC-005 intravenous (IV) (various doses and dose regimens)
干预措施: SC-005 (Drug)
结局指标
主要结局
Number of Participants with Dose-limiting Toxicities (DLTs)
时间窗: Minimum 21 days
DLTs graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03.
次要结局
- Area Under the Plasma Concentration-time Curve (AUC)(Up to approximately 9 weeks)
- Clinical benefit rate (CBR)(Up to approximately 4 years)
- Observed Plasma Concentrations at Trough(Up to approximately 9 weeks)
- Duration of Clinical Benefit (DOCB)(Up to approximately 4 years)
- Time of Cmax (Tmax)(Up to approximately 9 weeks)
- QTcF Change from Baseline(Up to approximately 9 weeks)
- Maximum plasma concentration observed (Cmax)(Up to approximately 9 weeks)
- Overall Survival (OS)(Up to approximately 4 years)
- Objective Response Rate (ORR)Up to approximately 4 years(Up to approximately 4 years)
- Progression Free Survival (PFS)(Up to approximately 4 years)
- Duration of Response (DOR)(Up to approximately 4 years)
研究者
研究点 (8)
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