NCT07524348招募中1 期
A Phase I, Open-Label, Multi-Center, First-in-Human Trial to Investigate E303, in Participants With Advanced Refractory Solid Tumors
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 149
- 试验地点
- 7
- 主要终点
- Incidence of adverse events and serious adverse events
研究概览
简要总结
This is a Phase I trial to evaluate the safety, tolerability and efficacy of nectin-4 targeting antibody-drug conjugate (SBE303) in participants with advanced solid tumors
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 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
- •Histologically-confirmed, locally advanced (unresectable) or metastatic solid tumors with recurrence or progression during or after standard therapy, intolerance to standard therapy, refused to receive standard therapy, or for whom no standard therapy is available.
排除标准
- •Have spinal cord compression or clinically active central nervous system metastases
- •Have leptomeningeal disease
- •Have thromboembolic or clinically significant bleeding events
- •Have significant cardiovascular disease
- •Have an active autoimmune disease
研究组 & 干预措施
E303
Experimental
干预措施: E303 (Drug)
结局指标
主要结局
Incidence of adverse events and serious adverse events
时间窗: Until trial completion (estimated 3 years)
Incidence of dose limiting toxicity
时间窗: For the first cycle of treatment, through pre-dose Cycle 2 Day 1
Confirmed objective response rate
时间窗: 32 weeks
Efficacy endpoint per Blinded Independent Central Review (BICR), according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
次要结局
- Terminal half life of total E303(Until trial completion (estimated 3 years))
- Incidence and titer of anti-drug antibodies(Until trial completion (estimated 3 years))
- Incidence of neutralizing antibodies(Until trial completion (estimated 3 years))
- Disease control rate(32 weeks)
- Tumor response(32 weeks)
- Area under the plasma/serum concentration vs time curve of total E303(Until trial completion (estimated 3 years))
- Maximum plasma/serum concentration of total E303(Until trial completion (estimated 3 years))
- Time to reach maximum plasma/serum concentration of total E303(Until trial completion (estimated 3 years))
- Plasma/serum concentration before the next dose of total E303(Until trial completion (estimated 3 years))
研究者
研究点 (7)
Loading locations...
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