NCT04257617已完成1 期
First in Human, Phase I Trial of ZL-1201 in Subjects With Advanced Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 7
- 主要终点
- Safety and tolerability of ZL-1201 when administered as an intravenous (IV) infusion: Incidence of Treatment-Emergent Adverse Events
研究概览
简要总结
First in Human, Phase I Trial of ZL-1201 in Subjects with Advanced Cancer
详细描述
This is a first-in-human, dose escalation trial of ZL-1201. The major aims of the study are to define the safety profile of this new drug, and to determine a recommended dose and schedule for potential additional trials.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Histologically/cytologically confirmed, locally advanced unresectable or metastatic solid tumors and lymphomas that are refractory or intolerant to standard of care therapy, or for which no standard therapy exists.
- •Adequate hematologic status
- •Adequate coagulation function
- •Adequate hepatic function
- •Adequate renal function
排除标准
- •Known active brain metastases
- •Red blood cells transfusion dependence
- •Known cardiopulmonary disease
- •Pregnant or breast-feeding females
- •Any other serious underlying medical
研究组 & 干预措施
Single arm, ZL-1201
Experimental
Single arm, ZL-1201
干预措施: ZL-1201 (Drug)
结局指标
主要结局
Safety and tolerability of ZL-1201 when administered as an intravenous (IV) infusion: Incidence of Treatment-Emergent Adverse Events
时间窗: From the time of informed consent to 30 days after last dose
Incidence of Treatment-Emergent Adverse Events as Assessed by CTCAE v5.0
次要结局
- Overall Response Rate (ORR）(Up to 2 years after enrollment)
- Pharmacokinetics：AUC(Up to 30 days after last dose)
- Immunogenicity(Up to 30 days after last dose)
- Pharmacokinetics: t1/2(Up to 30 days after last dose)
- Pharmacokinetics: Vss(Up to 30 days after last dose)
- Pharmacokinetics: Cmax(Up to 30 days after last dose)
- Pharmacokinetics: CL(Up to 30 days after last dose)
研究者
研究点 (7)
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