A Phase 1/2, Open-label, Multicenter Study to Investigate the Safety, Pharmacokinetics, and Efficacy of Fadraciclib (CYC065), an Oral CDK 2/9 Inhibitor, in Subjects With Advanced Solid Tumors and Lymphoma
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 330
- 试验地点
- 4
- 主要终点
- Overall Response Rate (ORR)
研究概览
简要总结
This is a 2-part, phase 1/2, open-label, multicenter study designed to evaluate the safety, tolerability, PK, pharmacodynamics, PGx, and efficacy of fadraciclib administered orally BID. This study consists of Phase 1 and Phase 2 components in subjects with advanced solid tumors and lymphoma who have progressed despite having standard therapy or for which no standard therapy exists.
详细描述
Phase 1 part of the study will consist of a dose-escalation and a dose-finding component .
Phase 2 will enroll subjects with locally advanced, recurrent, or metastatic, histologically confirmed advanced solid tumors or lymphoma, who have failed all standard therapies or for whom standard therapy does not exist, into 8 groups:
Group 1: Endometrial or Ovarian cancer
Group 2: Biliary tract cancer
Group 3: HCC
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 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
Phase I Dose escalation
Phase I = Fadraciclib administered orally in escalating doses starting at 50mg bid MWF for 3 weeks of a 4 week cycle. Subsequent cohorts will escalate in dose and schedule until optimized phase 2 dose and schedule is achieved.
Phase 2 = Recommended Fadraciclib phase 2 dose and schedule administered orally in 28 day cycles.
干预措施: Fadraciclib (Drug)
结局指标
主要结局
Overall Response Rate (ORR)
时间窗: 18 months
Assessment of response criteria according to RESIST, Lugano or mSWAT
Maximum tolerated dose
时间窗: 6 months
The incidence rate of dose-limiting toxicities (first cycle only) at each dose level
次要结局
- Tmax(6 months)
- AUC(6 months)
- Adverse events(24 months)
- Cmax(6 months)
- T1/2(6 months)