A Phase 1, Open-Label, Multi-center, Dose Escalation Study of the Safety and Pharmacokinetics of AGS-16M18 Given as Monotherapy in Subjects With Advanced Renal Cell Carcinoma
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Incidence of adverse events
研究概览
简要总结
This is a first in human study of AGS-16M18 given every week to subjects with advanced renal cell cancer. AGS-16M18 will be administered as a 60 minute IV infusion on consecutive days until the disease worsens.
详细描述
Subjects will be enrolled sequentially into 5 planned dose cohorts according to a standard, dose escalation study design. A disease assessment will be performed at study week 5 (+/- 3 days) by the investigator. The assessment will be based both on changes in clinical symptoms, and radiographic images. Subjects without evidence of disease progression may receive AGS-16M18 extended therapy at the dose and schedule of their assigned cohort until disease progression or intolerability of AGS-16M18. Disease assessments will be performed every 8 weeks during the extended period. A safety follow-up visit will occur 4 weeks after the last infusion of AGS-16M18.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Histologic or cytologic diagnosis (recent or remote) of metastatic renal cell carcinoma (including papillary, clear cell, and excluding transitional cell types) that is not amendable to cure by surgery or other means, and must have failed at least one prior systemic therapy, including but not limited to treatment with sunitinib, temsirolimus or sorafenib
- •Evaluable/Measureable disease according to Response Criteria for Solid tumors
- •Eastern Cooperative Group performance status of 0-1
- •Therapeutic anti-coagulation (PT, and/or INR, PTT) permitted, if clinically stable and >/= 3 months from initiation
排除标准
- •Past or present documented central nervous system (CNS) tumor or CNS metastasis
- •Use of investigational drug (including marketed drugs not approved for this indication) within 4 weeks prior to screening or 5 half-lives of the prior investigational drug (whichever is longer)
- •History of thromboembolic events and bleeding disorders </= 3 months (e.g., DVT or PE)
- •Major Surgery (that requires general anesthesia) within 4 weeks of study enrollment
结局指标
主要结局
Incidence of adverse events
时间窗: Throughout the treatment
Assessment of PK variables
时间窗: Weeks 0 - 5, week 8, weekly during extension period, 2 and 3 months after last dose
次要结局
- Incidence of anti-AGS-16M18 antibody formation(Week 0, week 1, week 4, week 8, every 8 weeks during extension period, 2 and 3 months after last dose)
- Changes in tumor status(Week 5, week 8, every 8 weeks during extension period)