A Multi-Center, Open Label Phase 1/2 Study of CYT-0851 in Patients With Relapsed/Refractory B-Cell Malignancies and Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 169
- 试验地点
- 16
- 主要终点
- Part B: Objective response rate
研究概览
简要总结
This clinical trial is an interventional, active-treatment, open-label, multi-center, Phase 1/2 study. The study objectives are to assess the safety, tolerability and pharmacokinetics (PK) of CYT-0851 in patients with relapsed/refractory B-cell malignancies and advanced solid tumors and to identify a recommended Phase 2 dose as a monotherapy and in combination with chemotherapy for evaluation in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
CYT-0851 dose escalation
Part A: CYT-0851 administered orally in rising doses QD or BID for 28 day cycles
干预措施: CYT-0851 (Drug)
CYT-0851 dose expansion
Part B: CYT-0851 administered orally at the selected Phase 2 dose for 28 day cycles
干预措施: CYT-0851 (Drug)
CYT-0851 and rituximab and bendamustine
Part C: Daily oral doses of CYT-0851 for 28 days in combination with rituximab on Day 1 and bendamustine on Days 1 and 2 of each 28 day cycle
干预措施: CYT-0851 (Drug)
CYT-0851 and rituximab and bendamustine
Part C: Daily oral doses of CYT-0851 for 28 days in combination with rituximab on Day 1 and bendamustine on Days 1 and 2 of each 28 day cycle
干预措施: CYT-0851 in combination with rituximab and bendamustine (Drug)
CYT-0851 and gemcitabine
Part D: Daily oral doses of CYT-0851 for 28 days in combination with gemcitabine on Day 1, 8 and 15 of each 28 day cycle
干预措施: CYT-0851 (Drug)
CYT-0851 and gemcitabine
Part D: Daily oral doses of CYT-0851 for 28 days in combination with gemcitabine on Day 1, 8 and 15 of each 28 day cycle
干预措施: CYT-0851 in combination with gemcitabine (Drug)
CYT-0851 and capecitabine
Part E: Daily oral doses of CYT-0851 for 21 days in combination with capecitabine on Days to 14 of each 21 day cycle
干预措施: CYT-0851 (Drug)
CYT-0851 and capecitabine
Part E: Daily oral doses of CYT-0851 for 21 days in combination with capecitabine on Days to 14 of each 21 day cycle
干预措施: CYT-0851 in combination with capecitabine (Drug)
结局指标
主要结局
Part B: Objective response rate
时间窗: 24 Weeks
clinical benefit as determined by investigator assessments of tumor response
Part D: Incidence of dose limiting toxicity
时间窗: 28 Days
Cycle 1 Dose limiting toxicities and determination of the maximum tolerated dose in combination with gemcitabine
Part E: Incidence of dose limiting toxicity
时间窗: 21 Days
Cycle 1 Dose limiting toxicities and determination of the maximum tolerated dose in combination with capecitabine
Part A: Incidence of dose limiting toxicity
时间窗: 28 Days
Cycle 1 Dose limiting toxicities and determination of the maximum tolerated dose
Part C: Incidence of dose limiting toxicity
时间窗: 28 Days
Cycle 1 Dose limiting toxicities and determination of the maximum tolerated dose in combination with rituximab and bendamustine
次要结局
- Part C: Incidence of adverse events and other safety measures(28 Days)
- Part C: Assessment of pharmacokinetic parameters(Phase 1: 12 months)
- Part B: Anti-tumor activity by PFS(24 months)
- Part D: Incidence of adverse events and other safety measures(28 Days)
- Part A: Incidence of adverse events and other safety measures(28 Days)
- Part E: Incidence of adverse events and other safety measures(21 Days)
- Part C: Objective response rate(24 months)
- Part B: Anti-tumor activity and by DOR(24 months)
- Part D: Assessment of pharmacokinetic parameters(Phase 1: 12 months)
- Part E: Assessment of pharmacokinetic parameters(Phase 1: 12 months)
- Part A: Objective response rate(24 months)
- Part B: Safety assessment(24 months)
- Part D: Objective response rate(24 months)
- Part B: Anti-tumor activity by OS(24 months)
- Part A: Assessment of pharmacokinetic parameters(Phase 1: 12 months)
- Part B: Assessment of pharmacokinetic parameters(Phase 1: 12 months)
- Part E: Objective response rate(24 months)
- Part B: Anti-tumor activity by DCR(24 months)