NCT05467943已完成2 期
A Multicenter, Open-label, Phase II Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Tazemetostat for the Treatment of Patients With Relapsed/Refractory Follicular Lymphoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Hutchmed
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- efficacy of Tazemetostat in EZH2 (MT) (Cohort 1)
研究概览
简要总结
Treating Relapsed/Refractory Follicular Lymphoma with Tazemetostat
详细描述
This is an open-label, monotherapy, Phase II Study clinical study. The objective is to evaluate the efficacy, safety, and pharmacokinetics of Tazemetostat in the treatment of patients with relapsed/refractory follicular lymphoma. It is planned to enroll 39 Chinese patients in 2 cohorts.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fully aware this study and signed the informed consent form in voluntary manner, and willing and able to comply with the study procedure;
- •Age ≥18 years;
- •Patients with histologically confirmed R/R FL (Grades 1, 2, 3a)
- •Patients must have one measurable lesion
- •Life expectancy ≥ 12 weeks;
- •Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 2
- •Adequate bone marrow function, renal function and hepatic function:
- •Currently human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV) or cytomegalovirus (CMV) is inactive:
- •Female patients of childbearing potential must agree to adopt dual contraceptive method
排除标准
- •Previous use of Tazemetostat or other EZH2 inhibitors;
- •Patients with invasion of lymphoma to the central nervous system (CNS) or the pia mater;
- •Previous bone marrow malignancies,
- •Abnormalities associated with MDS and myeloproliferative neoplasms observed by cytogenetic testing and DNA sequencing;
研究组 & 干预措施
Cohort 1 based on the EZH2 mutations
Experimental
MT patients with R/R FL; planned enrollment number: 19;
干预措施: Tazemetostat (Drug)
Cohort 2 based on the EZH2 mutations,
Experimental
WT patients with R/R FL; planned enrollment number: 20;
干预措施: Tazemetostat (Drug)
结局指标
主要结局
efficacy of Tazemetostat in EZH2 (MT) (Cohort 1)
时间窗: 22 months
Objective response rate (ORR) of Cohort 1 evaluated by the Independent Review Committee (IRC) \[based on the International Working Group-Non-Hodgkin's Lymphoma \[IWG-NHL\] (Cheson) 2007\]
次要结局
- Median time to reach maximum concentration (Tmax) of tazemetostat and its metabolite EPZ-6930 in blood(Cycle1Day 1: predose of first administration; 0.5, 1, 2, 4, 6, 8, and 12 hours postdose. Cycle1Day15: predose of first administration; 0.5, 1, 2, 4, 6, 8, and 12 hours postdose. Cycle2Day1 and Cycle3Day1: predose of first administration.)
- efficacy of Tazemetostat in EZH2 (WT) (Cohort 2)(22 months)
- safety of Tazemetostat in EZH2 (WT) (Cohort 2)(22 months)
- Geomean maximum concentration (Cmax) of tazemetostat and its metabolite EPZ-6930 in blood(Cycle1Day1: predose of first administration; 0.5, 1, 2, 4, 6, 8, and 12 hours postdose. Cycle1Day15: predose of first administration ; 0.5, 1, 2, 4, 6, 8, and 12 hours postdose. Cycle2Day1 and Cycle3Day1: predose of first administration.)
- Geomean area under the drug concentration-time curve (AUC) of tazemetostat and its metabolite EPZ-6930 after administration of tazemetostat(Cycle1Day1: predose of first administration; 0.5, 1, 2, 4, 6, 8, and 12 hours postdose. Cycle1Day15: predose of first administration; 0.5, 1, 2, 4, 6, 8, and 12 hours postdose)
- Geomean minimum observed concentration at steady-state (Cmin) of tazemetostat and its metabolite EPZ-6930 in blood(Cycle1Day15, Cycle2Day1 and Cycle3Day1: predose of first administration)
研究者
研究点 (1)
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相关资讯
Hengrui Medicine Receives China's First EZH2 Inhibitor Approval for Hematological Malignancies- Hengrui Medicine's Zemetostat received conditional approval from China's NMPA, becoming the country's first EZH2 inhibitor for treating relapsed or refractory peripheral T-cell lymphoma.
- The drug demonstrated a 34% objective response rate in Phase II trials for patients with relapsed/refractory follicular lymphoma and EZH2 mutations, addressing a critical unmet medical need.
- Hengrui's regulatory milestone positions the company to capture significant market share in the global EZH2 inhibitors market, projected to reach $9.59 billion by 2034.
- The approval represents a strategic breakthrough for Hengrui's transition from generic drugs to innovative therapies, with innovative drug revenue accounting for 61% of total income.last yearChina's NMPA Grants Conditional Approval to Tazemetostat for EZH2-Mutant Follicular Lymphoma- China's National Medical Products Administration (NMPA) has granted conditional approval to tazemetostat (Tazverik) for adult patients with relapsed or refractory EZH2-mutated follicular lymphoma who have received at least two prior systemic therapies.
- Tazemetostat is the first and only EZH2 inhibitor approved in China, representing HUTCHMED's fourth approved product and its first in hematological malignancies, following previous approvals in the US and Japan.
- The approval was supported by a Phase II bridging study in China and international clinical trials, with the ongoing SYMPHONY-1 trial serving as the confirmatory study to validate clinical benefits.last year