NCT04446260已完成1 期
A Phase 1 Multi-Country, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-A1811 in HER2 Expressing or Mutated Advanced Malignant Solid Tumor Subjects
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
- 396
- 试验地点
- 35
- 主要终点
- Incidence and severity of adverse events (AEs)
研究概览
简要总结
This is an open-label, two-part study to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of SHR-A1811 and preliminary anti-tumor efficacy in HER2 expressing or mutated advanced malignant solid tumor subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Advanced/unresectable or metastatic solid tumor with HER2 expression or mutation that is refractory to or intolerable with standard treatment, or for which no standard treatment is available
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •LVEF ≥ 50% by either ECHO or MUGA
- •Has adequate renal and hepatic function
- •Female subjects agree not to be pregnant or lactating from beginning of the study screening until 6 months after receiving the last treatment
排除标准
- •History of clinically significant lung diseases (e.g., interstitial pneumonia, pneumonitis, pulmonary fibrosis, and severe radiation pneumonitis) or suspected to have these diseases by imaging at screening period
- •Known hereditary or acquired bleeding and thrombotic tendency
研究组 & 干预措施
Part 1 Dose escalation
Experimental
干预措施: SHR-A1811 (Drug)
Part 2 PK expansion
Experimental
干预措施: SHR-A1811 (Drug)
Part 3 Indication expansion
Experimental
干预措施: SHR-A1811 (Drug)
结局指标
主要结局
Incidence and severity of adverse events (AEs)
时间窗: From Day1 to 90 days after last dose
Frequency and seriousness of treatment emergent adverse events (TEAEs)
次要结局
- PK parameter: Tmax of SHR-A1811(Through study completion, an average of 1 year)
- PK parameter: Cmax of SHR-A1811(Through study completion, an average of 1 year)
- PK parameter: AUC0-t of SHR-A1811(Through study completion, an average of 1 year)
- Immunogenicity of SHR-A1811(Through study completion, an average of 1 year)
- Tumor response using RECIST 1.1(From first dose to disease progression or death, whichever comes first, up to 30 months)
研究者
研究点 (35)
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