A Multi-center Open-label, Phase I/II Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ICP-192 in Patients With Advanced Solid Tumors and FGFR Gene Alterations
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 45
- 试验地点
- 16
- 主要终点
- RP2D
研究概览
简要总结
This is a multi-center, open-label, phase I/II clinical study to evaluate ICP-192 in patients with advanced solid tumors and FGFR gene alterations. It consists of two parts: Part I (Phase I), dose escalation and Part II (Phase II), dose expansion.
详细描述
Part I (Phase I) of the study enrolls patients with advanced solid tumors (9-15 patients); Part II (Phase II) of the study enrolls patients with urothelial carcinoma or cholangiocarcinoma with FGFR genetic alterations (30 patients).
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-192
- Dose Escalation Phase ICP-192
- Dose Expansion Phase ICP-192
干预措施: Drug ICP-192 (Drug)
结局指标
主要结局
RP2D
时间窗: Up to 3 years
Phase I: Dose Escalation To determine Recommended Phase 2 Dose (RP2D) for ICP-192
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
时间窗: Up to 3 years
Phase I: Dose Escalation \& Phase II: Dose Expansion To evaluate the safety and tolerability of different doses of ICP-192 in patients with advanced solid tumors
OBD
时间窗: Up to 3 years
Phase I: Dose Escalation To determine Optimal Biological Dose (OBD) for ICP-192
ORR
时间窗: Up to 3 years
Phase II: Dose Expansion Objective Response Rate
MTD
时间窗: Up to 3 years
Phase I: Dose Escalation To determine Maximum Tolerated Dose（MTD) for ICP-192
次要结局
- OS(Up to 3 years)
- PFS(Up to 3 years)
- AUC(Up to 3 years)
- Peak concentration (Cmax)(Up to 3 years)
- DCR(Up to 3 years)
- DOR(Up to 3 years)