NCT06845241尚未招募1 期
A Multi-center, Non-randomized, and Open-label Phase I/IIa Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of ICP-490 in Patients with Relapsed or Refractory Non-Hodgkin Lymphoma
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 68
- 试验地点
- 6
- 主要终点
- Incidence, type, and severity of adverse events (AEs) as judged according to NCI-CTCAE V5.0
研究概览
简要总结
This is a multi-center, non-randomized and open-label phase I/IIa clinical study to evaluate the safety, tolerability, and efficacy of ICP-490 in patients with relapsed or refractory non-hodgkin lymphoma.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
ICP-490
Experimental
干预措施: ICP-490 (Drug)
结局指标
主要结局
Incidence, type, and severity of adverse events (AEs) as judged according to NCI-CTCAE V5.0
时间窗: Through study completion，an average of 3 years
Incidence, type, and severity of dose-limiting toxicities (DLTs);
时间窗: Through study completion，an average of 3 years
Recommended Phase 2 Doses（RP2Ds） and/or maximum tolerated doses（MTDs）.
时间窗: Through study completion，an average of 3 years
ORR assessed according to the Lugano criteria (Cheson 2014).
时间窗: Through study completion，an average of 3 years
次要结局
- Overall survival (OS)(Through study completion，an average of 3 years)
- PK parameters: time to maximum concentration (Tmax)(Through study completion，an average of 3 years)
- PK parameters: maximum concentration (Cmax)(Through study completion，an average of 3 years)
- PK parameters: half-life (T1/2)(Through study completion，an average of 3 years)
- PK parameters: area under the concentration-time curve (AUC0-∞ and AUC0-t)(Through study completion，an average of 3 years)
- The overall response rate (ORR) assessed according to the Lugano criteria (Cheson 2014).(Through study completion，an average of 3 years)
- Time to response (TTR) assessed according to the Lugano criteria (Cheson 2014).(Through study completion，an average of 3 years)
- PK parameters: apparent clearance (CL/F)(Through study completion，an average of 3 years)
- Duration of response (DOR) assessed according to the Lugano criteria (Cheson 2014).(Through study completion，an average of 3 years)
- PK parameters: apparent volume of distribution during terminal phase (Vz/F)(Through study completion，an average of 3 years)
- PK parameters:Steady-state PK parameters(Through study completion，an average of 3 years)
- Complete response rate (CRR) assessed according to the Lugano criteria (Cheson 2014).(Through study completion，an average of 3 years)
- Progression-free survival (PFS) assessed according to the Lugano criteria (Cheson 2014).(Through study completion，an average of 3 years)
研究者
研究点 (6)
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