EUCTR2015-004206-42-GB进行中（未招募）1 期
A Phase I/Ib open-label, multi-center, dose escalation study of GWN323 (anti-GITR) as a single agent and in combination with PDR001 (anti-PD-1) in patients with advanced solid tumors and lymphomas
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 264
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
- 性别
- All
入选标准
- •- Patients with metastatic and/or advanced solid tumors or lymphomas not amenable to curative treatment by surgery.
- •- Histologically documented advanced or metastatic solid tumors or lymphomas
- •- Must have a site of disease amenable to biopsy, and be a candidate for tumor biopsy according to the treating institution’s guidelines. Patient must be willing to undergo a new tumor biopsy at screening
- •-ECOG Performance Status = 2.
- •Other protocol-defined inclusion criteria may apply.
- •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 204
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
排除标准
- •- Presence of symptomatic central nervous system (CNS) metastases, or CNS metastases that require local CNS-directed therapy (such as radiotherapy or surgery).
- •- Patients diagnosed with T-cell Lymphomas.
- •- Patients with prior allogenic transplants.
- •- Patients previously treated with anti-GITR therapy.
- •- History of severe hypersensitivity reactions to other mAbs.
- •- Patients intolerant to prior immunotherapy (unable to continue/receive due to immune-related AE).
- •Other protocol-defined exclusion criteria may apply.
研究者
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