NCT05463432已完成1 期
An Open-label Phase 1a Study of the Safety and Tolerability of HR19024 Injection in Subjects With Advanced Solid Tumor
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
- 71
- 试验地点
- 1
- 主要终点
- Maximum tolerated dose (MTD) of HR19024
研究概览
简要总结
To evaluate the safety，tolerability，pharmacokinetic characteristics and preliminary efficacy of HR19024 injection in the treatment of advanced solid tumor
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
- •ECOG performance status 0 or 1
- •Histologically confirmed advanced solid tumor
- •Life expectancy of greater than or equal to (>=) 12 weeks
- •At least one measurable lesion is present according to the efficacy evaluation criteria for solid tumors (RECIST 1.1)
- •Able and willing to provide a written informed consent
排除标准
- •Subjects with unresolved toxicity （> CTCAE G1）of prior therapy at the time of enrolment
- •Subjects who had received anti-tumor treatments such as surgery, chemotherapy, radiotherapy recently
研究组 & 干预措施
HR19024
Experimental
Part 1: Dose escalation of HR19024 montherapy for advanced solid tumor Part 2：PK expansion of HR19024 montherapy for advanced solid tumor Part 3: Efficacy expansion of HR19024 montherapy for advanced solid tumor
干预措施: HR19024 (Drug)
结局指标
主要结局
Maximum tolerated dose (MTD) of HR19024
时间窗: 21-day cycle (tri-weekly)
次要结局
- Disease Control Rate(up to 6 months following the date the last patient was randomized)
- Progression free survival (PFS)(up to 6 months following the date the last patient was randomized)
- Response rate (RR)(up to 6 months following the date the last patient was randomized)
- Duration of Response(up to 6 months following the date the last patient was randomized)
研究者
研究点 (1)
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