A Phase Ia /Ib Dose Finding Study to Evaluate the Safety, Tolerability and Pharmacokinetics and Preliminary Anti-Tumor Activity of ICP-189 and ICP-189 in Combination With Anti-PD-1 Monoclonal Antibody in Patients With Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- The incidence and severity of adverse event (AE) of ICP-189 assessed by NCI-CTCAE V5.0
研究概览
简要总结
A Dose finding Study to Evaluate the Safety, Tolerability and Pharmacokinetics and Preliminary Anti-Tumor Activity of ICP-189 Tablets and ICP-189 Tablets in Combination with Anti-PD-1 Monoclonal Antibody in Patients with Advanced Solid 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
- 18 Years 至 75 Years（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 histologically confirmed locally advanced unresectable or metastatic solid tumors;
- •At least one measurable lesion according to RECIST 1.1.
排除标准
- •Patients who have had other cancer(s) within 5 years prior to the first dose, except for locally curable cancers that have been apparently cured;
- •Patients with unstable primary central nervous system (CNS) tumors or CNS metastases;
- •Patients who have an active autoimmune disease or have had an autoimmune disease with risk of recurrence;
- •Patients who have active or history of interstitial lung disease or non-infectious pneumonia;
- •Patients who have a history of severe allergic reaction to any component of ICP-189 tablets or anti-PD-1 antibody (> grade 3 assessed by CTCAE 5.0).
- •Other protocol-defined inclusion/exclusion criteria apply.
研究组 & 干预措施
Phase Ia: ICP-189 Dose Escalation
干预措施: ICP-189 (Drug)
结局指标
主要结局
The incidence and severity of adverse event (AE) of ICP-189 assessed by NCI-CTCAE V5.0
时间窗: through study completion, an average of 2 years
To assess the safety and tolerability of ICP-189 in patients with advanced solid tumors.
Dose-Limiting Toxicities (DLTs)
时间窗: through study completion, an average of 2 years
Percentage of Participants Experiencing Dose Limiting Toxicities (DLTs).
Recommended Phase 2 Dose (RP2D) and/or maximum tolerated dose (MTD)
时间窗: through study completion, an average of 2 years
To preliminarily determine the PR2D and the MTD of ICP-189 in patients with advanced solid tumors
次要结局
- The maximum plasma concentration observed (Cmax)(through study completion, an average of 2 years)
- Time of maximum observed plasma concentration (Tmax)(through study completion, an average of 2 years)
- Area under plasma concentration-time curve (AUC0-t and AUC0-∞)(through study completion, an average of 2 years)
- Apparent volume of distribution (Vz/F)(through study completion, an average of 2 years)
- Progression-free survival (PFS)(through study completion, an average of 2 years)
- Apparent clearance (CL/F)(through study completion, an average of 2 years)
- Duration of response (DoR)(through study completion, an average of 2 years)
- Overall survival (OS)(through study completion, an average of 3.5 years)
- Elimination half-life (t1/2)(through study completion, an average of 2 years)
- The objective response rate (ORR)(through study completion, an average of 2 years)