JPRN-jRCT2031220414招募中1 期
A Phase I, Open-Label, Multicenter Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-A2009 for Injection in Patients With Advanced Solid Tumors
Shi Wei0 个研究点目标入组 132 人开始时间: 2022年10月26日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 132
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 <= 70age old（—）
- 性别
- All
入选标准
- •1.Patients with histologically or cytologically confirmed unresectable locally advanced or metastatic solid tumors which isrelapsed or refractory to standard treatment, or lack of standard treatment, or standard treatment is not applicablecurrently;
- •2.Have at least one measurable tumor lesion per RECIST v1.1 (patients with only non-target lesions are allowed to beenrolled in dose escalation stage);
- •3.ECOG performance status of 0-1;
- •4.Life expectancy >=12 weeks;
- •5.Adequate bone marrow and organ function .
- •6.Subjects must voluntarily agree to participate in the trial and sign a written informed consent form.
排除标准
- •1.Patients with symptomatic central nervous system metastases or meningeal metastases;
- •2.Ongoing or previous anti-tumor therapies within 4 weeks prior to the first dose of study drug;
- •3.Prior treatment with antibody-drug conjugate (ADC) consisting of topoisomerase I inhibitors;
- •4.History of serious cardiovascular and cerebrovascular diseases;
- •5.Severe infection within 4 weeks prior to the first dose;
- •6.Adverse reactions of previous anti-tumor treatment have not recovered to Grade=< 1 per NCI-CTCAE v5.0.
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