A Phase Ia/b Trial to Evaluate the Safety and Tolerability of CG-806 in Patients With CLL/SLL or Non-Hodgkin's Lymphomas
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 36
- 试验地点
- 30
- 主要终点
- Establish a CG-806 dose that maintains a biologically active plasma concentration
研究概览
简要总结
This study is being done to evaluate the safety, tolerability and effectiveness of Oral CG-806 for the treatment of patients with chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), or Non-Hodgkin's Lymphomas who have failed or are intolerant to two or more lines of established therapy or for whom no other treatment options are available.
详细描述
This is a multicenter, open-label, Phase Ia/b dose escalation study of safety, pharmacodynamics, and pharmacokinetics of CG-806 in ascending cohorts (3+3 design) to determine the MTD or recommended dose in patients with relapsed or refractory CLL/SLL or Non-Hodgkin's Lymphoma patients. This is to be followed by a cohort expansion phase at the MTD or recommended oral dose.
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
- •Age ≥ 18 years
- •Life expectancy of at least 2 months
- •ECOG Performance Status ≤ 2
- •Patients must be able to swallow capsules
- •Adequate hematologic parameters, unless cytopenias are disease caused
- •Adequate renal, liver and cardiac function parameters
排除标准
- •Patients with GVHD requiring systemic immunosuppressive therapy
- •Uncontrolled leptomeningeal disease, auto-immune hemolytic anemia and uncontrolled and clinical significant disease related metabolic disorder
- •Clinically significant intravascular coagulation
- •Treatment with other investigational drugs within 14 days prior to first study treatment administration
研究组 & 干预措施
Dose Escalation and Expansion
CG-806 will be given orally in ascending doses in patients with relapsed or refractory CLL/SLL or Non-Hodgkin's Lymphomas (escalation cohort), until the maximum tolerated dose or recommended dose is reached. Followed by up to 100 patients enrolled in the expansion cohort at the recommended dose.
干预措施: CG-806 (Drug)
结局指标
主要结局
Establish a CG-806 dose that maintains a biologically active plasma concentration
时间窗: Cycle 1 (28 days)
To determine the dose of CG-806 given orally every 12 hours that maintains a biologically active plasma concentration over a period of 28 days.
Establish recommended dose for future development of CG-806
时间窗: Up to 10 months
To establish the recommended Phase 2 dose (RP2D) of CG-806 for future clinical trials in patients with advanced CLL/SLL or NHL.
Incidence of treatment-emergent adverse events of CG-806
时间窗: Cycle 1 (28 days)
To determine the safety and tolerability of CG-806.
次要结局
- Pharmacokinetic variables including maximum plasma concentration (Cmax)(Cycle 1 (28 days))
- Pharmacokinetic variables including minimum plasma concentration (Cmin)(Cycle 1 (28 days))
- Pharmacokinetic variables including Area Under the Curve (AUC) Pharmacokinetic variables including Area Under the Curve (AUC Pharmacokinetic variables including Area Under the Curve (AUC(Cycle 1 (28 days))
- To assess the relative BA of formulation G1 against formulation G3(Cycle 1 Lead-Up (3 days))
- To assess the antitumor activity of CG-806 using FDG PET-CT imaging evaluations(Average 2 Cycles (8 weeks))
- Pharmacodynamic biomarkers of drug effect including selected mRNA levels(Average 2 cycles (8 weeks))
- Pharmacokinetic variables including volume of distribution(Cycle 1 (28 days))
- Pharmacokinetic variables including serum half-life(Cycle 1 (28 days))
- Pharmacokinetic variables including clearance(Cycle 1 (28 days))
- Pharmacodynamic biomarkers of drug effect including BTK activity(Average 2 cycles (8 weeks))
- To assess the relative BA of formulation G1 against formulation G2(Cycle 1 (28 days))