A Phase I Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of ICP-033 in Patients With Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Recommended phase II dose (RP2D)
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-033 Tablets 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
- •Pregnant and lactating women, or women planning to become pregnant during the study through at least 6 months after the last dose of study drug.
- •Patients with unstable primary central nervous system (CNS) tumors or CNS metastases.
- •Patients who have active or history of interstitial lung disease or noninfectious pneumonia.
- •Patients with QTc > 450 ms in males and > 470 ms in females on ECG at screening, or other clinically significant abnormalities in the ECG at the discretion of the investigator.
- •Patient with the Medication history and surgical history as stated in the protocol
- •Those who are unsuitable for blood collection or contraindicated for blood collection.
- •Other conditions considered unsuitable for participation in this trial at the discretion of the investigator.
研究组 & 干预措施
ICP-033 Dose Escalation
Drug: ICP-033 tablet Administered orally，once a day，every 28 days is a cycle.
干预措施: ICP-033 tablet (Drug)
结局指标
主要结局
Recommended phase II dose (RP2D)
时间窗: through study completion, an average of 2 years
The incidence and severity of adverse event (AE) of ICP-033 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-033 in patients with advanced solid tumors.
Dose-Limiting Toxicities (DLTs)
时间窗: through study completion, an average of 2 years
To assess the safety and tolerability of ICP-033 in patients with advanced solid tumors.
Maximum tolerated dose (MTD)
时间窗: through study completion, an average of 2 years
To assess the safety and tolerability of ICP-033 in patients with advanced solid tumors.
次要结局
- Overall survival (OS)(through study completion, an average of 2 years)
- 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)
- Elimination half-life (t1/2)(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)
- The objective response rate (ORR)(through study completion, an average of 2 years)
- Duration of response (DoR)(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)
- Apparent volume of distribution (Vz/F)(through study completion, an average of 2 years)