NCT03253185终止1 期
An Open Label Study of SC-007 in Subjects With Advanced Cancer
AbbVie7 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2017年9月13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
- 7
- 试验地点
- 7
- 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, Phase 1 study in participants with colorectal cancer (CRC) or gastric cancer to study the safety and tolerability of SC-007 and consists of Part A (dose regimen finding) in participants with CRC followed by Part A in participants with gastric cancer. Part B (dose expansion) will enroll participants into separate disease specific cohorts of CRC or gastric cancer.
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
- 是
入选标准
- •Histologically or cytologically confirmed advanced metastatic or unresectable advanced colorectal cancer (CRC) or gastric cancer that is relapsed, refractory, or progressive after:
- •CRC: at least 2 prior systemic regimens in the metastatic setting, and as appropriate in patients whose tumors are microsatellite instability-high (MSI-H), pembrolizumab as well.
- •Gastric cancer (including gastric and EGJ cancers): at least 2 prior systemic regimens in adjuvant, advanced, or metastatic setting and, as appropriate, a human epidermal growth factor receptor 2 (HER2) targeted agent.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •Adequate hematologic, hepatic, and renal function.
排除标准
- •Any significant medical condition that, in the opinion of the investigator or sponsor, may place the participant at undue risk from the study.
- •Has electrocardiogram (ECG) abnormalities that make QT interval corrected (QTc) evaluation difficult.
- •Prior exposure to a pyrrolobenzodiazepine or indolinobenzodiazepine based drug.
研究组 & 干预措施
SC-007
Experimental
SC-007 intravenous (IV) (various doses and dose regimens)
干预措施: SC-007 (Drug)
结局指标
主要结局
Number of participants with dose-limiting toxicities (DLTs)
时间窗: Minimum first cycle of dosing (Up to 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
- Clinical Benefit Rate (CBR)(Approximately 4 years)
- Progression Free Survival (PFS)(Approximately 4 years)
- Observed plasma concentrations at trough (Ctrough) of SC-007(Approximately 1 year)
- Incidence of Anti-therapeutic Antibodies (ATAs) against SC-007(Approximately 4 years)
- Overall Survival (OS)(Approximately 4 years)
- Terminal half life (T1/2) of SC-007(Approximately 1 year)
- Objective Response Rate (ORR)(Approximately 4 years)
- Duration of Response (DOR)(Approximately 4 years)
- Time to Cmax (Tmax) of SC-007(Approximately 1 year)
- Area under the plasma concentration-time curve within a dosing interval (AUC) of SC-007(Approximately 1 year)
- QTcF Change from Baseline(Up to 9 weeks based on 3 cycles of dosing (21-day cycles))
- Maximum observed serum concentration (Cmax) of SC-007(Approximately 1 year)
研究者
研究点 (7)
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