NCT04513223已完成1 期
Safety, Tolerability, Pharmacokinetics, and Antitumour Activity of SHR-A1811, in Patients With HER2-expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma and Colorectal Cancer: a Phase 1 Study
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
- 101
- 试验地点
- 1
- 主要终点
- DLT and the recommended Phase 2 dose (RP2D)
研究概览
简要总结
This is a single arm, open-label, dose escalation, PK expansion and efficacy expansion study of phase I. The purpose of this study is to assess the tolerability, safety, pharmacokinetics and immunogenicity of SHR-A1811 and preliminary anti-tumor efficacy in HER2-expressing advanced gastric or gastroesophageal junction adenocarcinoma and colorectal cancer.
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
- •Has a pathologically or cytologically documented advanced/unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma and colorectal cancer that is refractory to or intolerable with standard treatment, or for which no standard treatment is available.
- •At least one evaluable or measurable lesion should be present and identified according to Response Evaluation Criteria in Solid Tumors(RECIST) version 1.
- •Has an ECOG PS 0-
- •Has a life expectancy of ≥ 3 months.
- •Has adequate organ function
排除标准
- •Has unresolved toxicities from previous anticancer therapy, defined as toxicities not yet resolved to NCI-CTCAE version 5.0 grade ≤
- •Has received HER2 antibody drug conjugates,.
- •Central nervous system metastasis or meningeal metastasis with clinical symptoms
- •Has active infection requiring systemic treatment.
研究组 & 干预措施
SHR-A1811
Experimental
干预措施: SHR-A1811 (Drug)
结局指标
主要结局
DLT and the recommended Phase 2 dose (RP2D)
时间窗: Subjects will be treated and observed for dose-limiting toxicity(DLT) through the end of the first cycle (Days 1-21).
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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