NCT03138408终止1 期
An Open Label, Phase 1 Study of SC-004 as Monotherapy and in Combination With ABBV-181 in Subjects With Epithelial Ovarian, Including Fallopian Tube and Primary Peritoneal and Endometrial Cancers
AbbVie12 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2017年6月14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
- 24
- 试验地点
- 12
- 主要终点
- Number of participants with dose-limiting toxicities (DLT)
研究概览
简要总结
This is a two-part study consisting of Part A (dose regimen finding) followed by Part B (dose expansion). Part A (dose regimen finding) will allow definition of the maximum tolerated dose (MTD) through dose escalation and possible dose interval modification. In Part B (dose expansion), potential therapeutic doses may be studied with SC-004 as monotherapy and SC-004 in combination with ABBV-181 in disease-specific cohorts.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed advanced malignancy defined as any of the following tumors for which no further standard or curative therapy exists or is considered appropriate by the Investigator:
- •Epithelial ovarian cancer, including fallopian tube cancer or primary peritoneal cancer, of high-grade serous histology, with platinum refractory or resistant disease after prior treatment with at least one platinum-based chemotherapeutic regimen. In Part B (dose expansion), subjects may have received no more than 3 lines of systemic cytotoxic chemotherapy.
- •Note, the line of therapy limit does not apply to the biopsy substudy cohorts.
- •Metastatic or advanced endometrial carcinoma previously treated with at least 1 platinum-based chemotherapeutic regimen.
- •Eastern Cooperative Oncology Group (ECOG) 0-
- •Adequate hematologic, hepatic, and renal function.
排除标准
- •Participants with prior exposure to a pyrrolobenzodiazepine or indolinobenzodiazepine based drug.
研究组 & 干预措施
SC-004
Experimental
干预措施: SC-004 (Drug)
SC-004 and ABBV-181
Experimental
干预措施: SC-004 (Drug)
SC-004 and ABBV-181
Experimental
干预措施: ABBV-181 (Drug)
结局指标
主要结局
Number of participants with dose-limiting toxicities (DLT)
时间窗: Minimum first cycle of dosing (21-day cycles)
DLTs graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03.
次要结局
- Objective Response Rate (ORR)(Approximately 2 years)
- Observed plasma concentrations at trough (Ctrough)(Approximately 1 year)
- Duration of Response (DOR)(Approximately 2 years)
- Area under the plasma concentration-time curve within a dosing interval (AUC)(Approximately 1 year)
- QTcF Change from Baseline(Up to 9 weeks based on 3 cycles of dosing (21-day cycles))
- Duration of Clinical Benefit (DOCB)(Approximately 2 years)
- Overall Survival (OS)(Approximately 2 years)
- Terminal half life (T1/2)(Approximately 1 year)
- Maximum observed serum concentration (Cmax)(Approximately 1 year)
- Time to Cmax (Tmax)(Approximately 1 year)
- Clinical Benefit Rate (CBR)(Approximately 2 years)
- Progression Free Survival (PFS)(Approximately 2 years)
研究者
研究点 (12)
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