An Open-label, First-in-human, Dose Escalation and Expansion Phase I Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetic Profile of JS201 in Patients With Advanced Malignant Tumors
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 244
- 试验地点
- 18
- 主要终点
- Number of Subjects with serious adverse event (SAE)
研究概览
简要总结
This is an open label, phase I clinical study to evaluate the safety, tolerability, pharmacokinetic (PK) profile, pharmacodynamic (PD) profile, immunogenicity and preliminary efficacy of JS201 in the patients with advanced malignant tumors who have progression after or during the standard of care, or no effective standard therapeutic regimen. This study is divided into three phases: dose-escalation phase, dose expansion phase, and clinical expansion phase.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
JS201
干预措施: JS201 (Drug)
结局指标
主要结局
Number of Subjects with serious adverse event (SAE)
时间窗: Up to 2 years
A Serious Adverse Event (SAE) is an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect
Number of Subjects with immune related adverse event (irAE)
时间窗: Up to 2 years
IrAE is assessed according to the judgement of investigators
Number of Subjects with adverse event (AE)
时间窗: Up to 2 years
An Adverse Event (AE) is defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship.
Number of subjects with DLT (Dose limiting Toxicity)
时间窗: 21 days after first infusion of study drug
DLT is defined as any of the specified toxicities evaluated as at least possibly related with the study drug within 21 days after the first dose (NCI-CTCAE v5.0);
次要结局
- elimination half-life (t1/2)(Up to 2 years)
- OS(Up to 2 years)
- trough concentration (Ctrough)(Up to 2 years)
- area under the plasma drug concentration-time curve (AUC0-t )(Up to 2 years)
- volume of distribution (Vss)(Up to 2 years)
- clearance rate (CL)(Up to 2 years)
- ORR(Up to 2 years)
- DOR(Up to 2 years)
- anti-drug body (ADA)(Up to 2 years)
- peak concentration (Cmax)(Up to 2 years)
- DCR(Up to 2 years)
- PFS(Up to 2 years)