EUCTR2016-001080-36-BE进行中（未招募）1 期
A Phase 1b/2 Study Assessing Safety and Anti-tumor Activity of AMG 820 in Combination With Pembrolizumab in Select Advanced Solid Tumors
Amgen Incorporated0 个研究点目标入组 197 人开始时间: 2016年11月4日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 197
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •- Pathologically documented, advanced colorectal, pancreatic or non-small cell lung cancer that is refractory to standard treatment, or the subjects have been intolerant to or refuse standard treatment.
- •- Measurable disease per RECIST 1.1 guidelines.
- •- Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1
- •- Adequate hematologic, renal, and hepatic function determined by laboratory blood and urine tests.
- •- Availability of recent tumor tissue with 3 months prior to enrollment, when feasible.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 150
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 47
排除标准
- •- Has known active central nervous system metastases
- •- History of other malignancy with the past 2 years with some exceptions
- •- Subject has history of interstitial lung disease, (non-infectious) pneumonitis that required steroids, or current pneumonitis.
- •- History or evidence of other active autoimmune diseases that has required prolonged systemic treatment in past 2 years (ie, with use of disease modifying agents such as corticosteroids or immunosuppressive drugs).
- •- Prior chemotherapy, radiotherapy, biological cancer therapy or major surgery within 28 days prior to enrollment
- •- Currently participating or has participated in a study (treatment period only) of an investigational agent or used an investigational device within 28 days of enrollment
- •- Received live vaccine within 28 days prior to enrollment
- •- Adverse event due to cancer therapy administered more than 28 days prior to enrollment that has not recovered to CTCAE grade 1 or better.
- •- Positive for human immunodeficiency virus (HIV), Hepatitis B or C
- •- Women planning to become pregnant or who are lactating/breastfeeding while on study through 4 months after receiving the last dose of study drug.
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