NCT05745623招募中1 期
A Multi-center, Non-Randomized, Open-Label Phase 2 Basket Clinical Trial to Evaluate ICP-723 in Patients With Advanced Solid Tumors or Primary Central Nervous System 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
- 70
- 试验地点
- 1
- 主要终点
- Objective response rate (ORR)
研究概览
简要总结
A Multi-center, Non-Randomized, Open-Label Phase 2 Basket Clinical Trial to Evaluate ICP-723 in Patients with Advanced Solid Tumors or Primary Central Nervous System Tumors
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
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
- •Patients with advanced solid tumors or primary central nervous system (CNS) tumors harboring NTRK gene fusions as detected by the designated central laboratory, who received no previous NTRK inhibitor treatment;
- •At least one measurable lesion as per RECIST1.1 criteria, or for primary CNS tumors, at least one measurable lesion as per RANO or INRC criteria.
- •Organ functions meet the clinical criteria
排除标准
- •Patients with unstable primary central nervous system (CNS) tumors or CNS metastasis.
- •Patients with abnormal QTc interval at screening, or other clinically significant abnormalities in electrocardiographic examination at the discretion of the investigator.
- •Patient with recent anti-tumor and other treatment as stated in the protocol.
- •Grade 1 or higher toxicities attributed to any previous treatment not yet recovered.
- •Other conditions considered unsuitable for participation in this trial at the discretion of the investigator
研究组 & 干预措施
ICP-723
Experimental
干预措施: ICP-723 (Drug)
结局指标
主要结局
Objective response rate (ORR)
时间窗: Through study completion, an average of 4 years
The objective response rate (ORR) evaluated by the Independent Center Review
次要结局
- Overall survival (OS)(Through study completion, an average of 4 years)
- Elimination half-life (t1/2)(Through study completion, an average of 4 years)
- Time to response (TTR) as assessed by the investigator and the IRC(Through study completion, an average of 4 years)
- The incidence, character and severity of adverse events as assessed per NCI-CTCAE v5.0 criteria(Through study completion, an average of 4 years)
- ORR assessed by the investigator(Through study completion, an average of 4 years)
- DCR as assessed by the investigator and the IRC(Through study completion, an average of 4 years)
- Apparent clearance (CL/F)(Through study completion, an average of 4 years)
- Time of maximum observed plasma concentration (Tmax)(Through study completion, an average of 4 years)
- AUC0-t(Through study completion, an average of 4 years)
- Progression-free survival (PFS) as assessed by the investigator and the IRC(Through study completion, an average of 4 years)
- central nervous system progression-free survival (CNS-PFS) as assessed by the investigator and IRC(Through study completion, an average of 4 years)
- Duration of response (DOR) as assessed by the investigator and the IRC(Through study completion, an average of 4 years)
- Intracranial objective response rate (IC-ORR) as assessed by the investigator and IRC(Through study completion, an average of 4 years)
- AUC0-∞(Through study completion, an average of 4 years)
- Apparent volume of distribution (Vz/F)(Through study completion, an average of 4 years)
- The maximum plasma concentration observed (Cmax)(Through study completion, an average of 4 years)
研究者
研究点 (1)
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