JPRN-jRCT2080222260已完成1 期
A Phase I, Open-Label, Multicentre Study to Evaluate the Safety, Tolerability and Pharmacokinetics of MEDI4736 in Patients With Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •In the dose-escalation phase: patients with advanced solid tumors refractory to standard treatment, intolerant of standard treatment, or for which no standard therapy exists.
- •- In the dose-expansion phase: histologically - or cytologically-confirmed advanced or metastatic biliary tract cancer (BTC), esophagus cancer(EC) (squamous cell carcinoma) or squamous cell carcinoma of the head and neck (SCCHN).
- •- Eastern Cooperative Oncology Group (ECOG) status of 0 or 1.
- •- Adequate organ and marrow function.
- •- Subjects must have at least 1 measurable lesion.
- •- Available archived tumor tissue sample.
- •- Willingness to provide consent for biopsy samples.
排除标准
- •-Any prior Grade 3 irAE or more while receiving immunotherapy
- •-Prior exposure to any anti-PD-1 or anti-PD-L1 antibody
- •-Active or prior documented autoimmune disease within the past 2 years
- •-History of primary immunodeficiency
- •-Symptomatic or untreated central nervous system (CNS) metastases requiring concurrent treatment
- •-Women who are pregnant or lactating
- •-Uncontrolled intercurrent illness
- •-Known history of tuberculosis
- •-Known to be human immunodeficiency virus (HIV) positive
- •-Active infection including hepatitis B or hepatitis C
- •-Other invasive malignancy within 5 years
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