An Open-Label, Multicenter, Monotherapy, Dose-Escalation, Phase 1 Clinical Trial of NB02 (Posseltinib) in Patients With Relapsed/Refractory Non-Hodgkin's Lymphoma
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 9
- 试验地点
- 6
- 主要终点
- MTD(maximum tolerated dose) or OBD(optimal biological dose)
研究概览
简要总结
This trial is an open-label, multicenter, monotherapy, dose-escalation, phase 1 clinical trial to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary anti-tumor activity of NB02 (posseltinib) in patients with relapsed/refractory NHL including FL, MCL and MZL
详细描述
The study will conduct dose-finding. The dose-finding will be set as 3+3 design to seek candidates for optimal doses. Patients will receive study drugs to determine the MTD and/or OBD. In this study, OBD is defined as the most reasonable dose considering the benefit/risk ratio from available non-clinical and clinical data. The OBD will be determined based on available safety, PK/PD, and preliminary efficacy data, with a focus on identifying the dose that optimally balances clinical activity and tolerability.
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
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 19 to 80 years.
- •Patients must voluntarily agree to participate in the study and provide written informed consent prior to any study-related procedures.
- •Patients with histologically confirmed follicular lymphoma, mantle cell lymphoma or marginal zone lymphoma.
- •relapsed/refractory Patients who have received more than two prior lines of therapy.
- •Measurable disease based on Lugano classification.
- •Eastern Cooperative Oncology Group (ECOG) performance status of ≤
- •Adequate organ function including:
排除标准
- •Previous treatment with NB02 (poseltinib).
- •Patients who have experienced progression on BTKi mono or BTKi containing regimen (However, patients who discontinued treatment due to adverse-effect-related intolerance or for economic or social reasons remain eligible for enrollment).
- •Unable to take oral medication.
- •Inability to comply with study and follow-up procedures.
- •Concurrent use of other investigational drugs or enrollment in another clinical trial within 4 weeks prior to study drug administration.
- •Patients who have previously been treated with NB02 (poseltinib) or any other BTK inhibitors (e.g., ibrutinib, acalabrutinib, zanubrutinib).
- •Known HIV, HCV and HBV infection with active diseases
研究组 & 干预措施
NB02 (Poseltinib)
Dose Level 1 Dose Level 2 Dose Level 3
干预措施: NB02 (Poseltinib) (Drug)
结局指标
主要结局
MTD(maximum tolerated dose) or OBD(optimal biological dose)
时间窗: Approximately 48 Months
MTD(maximum tolerated dose) or OBD(optimal biological dose)
AEs
时间窗: Approximately 48 Months
AEs
次要结局
- Pharmacokinetic (PK) Ctrough(Day 147)
- Pharmacokinetic (PK) t1/2(Day 147)
- Pharmacokinetic (PK) CL/F(Day 147)
- Pharmacokinetic (PK) Vz/F(Day 147)
- Pharmacokinetic (PK) Cmax(Day 147)
- Pharmacokinetic (PK) AUCtau(Day 147)
- Pharmacokinetic (PK) Tmax(Day 147)
- Overall response rate (ORR)(Approximately 48 Months)
- Duration of response (DoR)(Approximately 48 Months)
- Time to response (TTR)(Approximately 48 Months)
- Progression-free survival (PFS)(Approximately 48 Months)
- Overall Survival (OS)(Approximately 48 Months)