NCT04877717进行中（未招募）1 期
An Open-Label, Single-Arm, Multi-Center Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of SHR-A1904 in Patients With Advanced Solid Tumors
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）
- 入组人数
- 107
- 试验地点
- 1
- 主要终点
- Determine the Maximum Tolerated Dose of SHR-A1904
研究概览
简要总结
The study is being conducted to assess the safety and tolerability of SHR-A1904 in patients with advanced solid cancer and to determine the dose-limiting toxicity (DLT), maximum tolerated dose (MTD), and recommended phase II dose (RP2D) of SHR-A1904
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
- •Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study
- •Males or females aged 18-75 years old
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- •Has a life expectancy≥ 3 months
- •Has at least one measurable lesion as defined by RECIST v1.1
- •Pathologically confirmed advanced solid cancer
排除标准
- •Plan to receive any other anti-tumor treatments during the study treatment period of this study
- •Received other clinical investigational products or treatments within 4 weeks before the first dose of the study
- •Received anti-tumor therapies such as chemotherapy, radiotherapy, biological therapy, targeted therapy, or immunotherapy within 4 weeks before the first dose of the study
- •Underwent a major surgery other than diagnosis or biopsy within 4 weeks before the first dose of the study
- •Subjects with known brain metastases
- •Grade II-IV cardiac insufficiency as per the New York Heart Association (NYHA) criteria; arrhythmia requiring long-term drug control; unstable angina or acute myocardial infarction within 6 months before the first dose of the study
- •presence of accompanying diseases (such as poorly controlled hypertension, serious diabetes mellitus, thyroid disorder, psychosis, etc.) that may pose serious risks to the safety of the subject or may affect the subject's ability to complete the study, or any other situation as judged by the investigator
研究组 & 干预措施
SHR-A1904
Experimental
干预措施: SHR-A1904 (Drug)
结局指标
主要结局
Determine the Maximum Tolerated Dose of SHR-A1904
时间窗: up to 1 year
次要结局
- Time to maximum concentration (Tmax)(up to 1 year)
- Area under the drug concentration-time curve from time 0 to the last measurable concentration time point (AUC0-t)(up to 1 year)
- Objective response rate (ORR)(up to 1 year)
- Maximum concentration (Cmax)(up to 1 year)
- Anti-drug antibody (ADA) of SHR-A1904(up to 1 year)
研究者
研究点 (1)
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