NCT06022250进行中（未招募）1 期
A Phase I Study to Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of JS207 in Patients With Advanced Malignant Tumor
Shanghai Junshi Bioscience Co., Ltd.1 个研究点 分布在 1 个国家目标入组 98 人开始时间: 2023年9月26日最近更新:
适应症
干预措施
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
- 98
- 试验地点
- 1
- 主要终点
- Dose-limiting toxicity （DLT）、adverse event（AE）
研究概览
简要总结
This is a Phase I open-label, multicenter study to evaluate the safety, tolerability, pharmacokinetics (PK),Pharmacodynamic characteristics, immunogenicity and antitumor activity of JS207 in patients with advanced malignant tumor. The Recommended dose for phase II trial （RP2D） will be determined based on the safety, tolerability, pharmacokinetics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with advanced malignant tumor confirmed by histology or pathology, failed by standard treatment, no standard treatment or no standard treatment is applicable;
- •Eastern Cooperative Oncology Group (ECOG) 0 or 1;
- •Life expectancy ≥ 12 weeks;
- •At least one measurable lesion according to RECIST 1.1;
- •Adequate organ function;
排除标准
- •central nervous system metastasis；
- •There is a pleural, abdominal or pericardial effusion that is clinically symptomatic or requires repeated management (puncture or drainage, etc.)；
- •Images in screening showed that the tumor surrounded important blood vessels or had obvious necrosis and voids, and the investigators believed that it might cause bleeding risk；
- •The presence of severe, unhealed or open wounds, active ulcers, or untreated fractures；
- •A history of significant bleeding tendency or severe coagulopathy；
- •The presence of poorly controlled hypertension；
研究组 & 干预措施
JS207
Experimental
干预措施: JS207 (Drug)
结局指标
主要结局
Dose-limiting toxicity （DLT）、adverse event（AE）
时间窗: 2 Years
Incidence and severity of DLT, adverse events (AE), Abnormal changes in laboratory and other tests with clinical significance
Maximum tolerated dose (MTD),RP2D
时间窗: 2 Years
Maximum tolerated dose (MTD), Recommended dose for phase II trial
次要结局
- Elimination half life（t1/2）(2 years)
- Peak concentration（Cmax）(2 years)
- Time to peak（Tmax）(2 years)
- Immunogenicity(2 years)
- Progression free survival(PFS)(2 years)
- Overall survival (OS)(2 years)
- Objective response rate (ORR) based on Response Evaluation Criteria In Solid Tumors 1.1 (RECIST1.1)(2 years)
研究者
研究点 (1)
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