A Phase 1, Open-label, Dose Escalation Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of ONO-7018 in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma (NHL) in Japan
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 2
- 试验地点
- 6
- 主要终点
- Dose-limiting toxicities
研究概览
简要总结
ONO-7018 is a selective inhibitor of mucosa associated lymphoid tissue protein 1 (MALT1) and is expected to exhibit antitumor activity in NHL. This study is Phase1 study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (biomarkers) and efficacy of ONO-7018 in patients with relapsed or refractory NHL.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with histologically/cytologically confirmed diagnosis of any of the subtypes of B-cell NHL or T-cell NHL defined below as documented by medical records and with histology based on criteria established by the World Health Organization (Swerdlow 2017)
- •Relapsed or refractory patient who is refractory or intolerant to standard therapy or for whom, in the opinion of the investigator, there is no appropriate treatment for the primary disease.
- •Patient who has measurable disease
- •Eastern Cooperative Oncology Group Performance Status 0 to 2
- •Life expectancy of at least 3 months
排除标准
- •Any serious or uncontrolled medical disorder that may increase the risk associated with study participation or study treatment, or interfere with the interpretation of study results
- •Patient with malignancies other than lymphoid malignancy allowed per inclusion criteria
- •Prior treatment with a MALT1 inhibitor
- •Patient is unable to swallow tablets
研究组 & 干预措施
Evaluation of Tolerability
Up to 4 dose levels will be evaluated. Eligible patients will be assigned to a dose level cohort according to a traditional 3+3 dose escalation design.
干预措施: ONO-7018 (Drug)
结局指标
主要结局
Dose-limiting toxicities
时间窗: up to 3 weeks after the first dose
Observed toxicities will be graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0 to assess the tolerability of ONO-7018.
Incidence, causality, and severity of Treatment emergent adverse events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
时间窗: Up to 28 days after the last dose
Adverse events with the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0 used as a guide for the grading of severity.
次要结局
- Time to response (TTR)(through study completion, an average of 1 year)
- Plasma Concentration of ONO-7018(up to 16 weeks after the first dose)
- Maximum observed concentration (Cmax)(up to 16 weeks after the first dose)
- Time to Cmax (Tmax)(up to 16 weeks after the first dose)
- Area under the concentration-time curve to the end of the dosing period (AUCtau)(up to 16 weeks after the first dose)
- Elimination half-life (T1/2)(up to 16 weeks after the first dose)
- Predose trough concentration (Ctrough)(up to 16 weeks after the first dose)
- Overall Response Rate (ORR)(through study completion, an average of 1 year)
- Complete response rate (CRR)(through study completion, an average of 1 year)
- Best overall response (BOR)(through study completion, an average of 1 year)
- Duration of response (DOR)(through study completion, an average of 1 year)
- Progression-free survival (PFS)(through study completion, an average of 1 year)
- Overall survival (OS)(through study completion, an average of 1 year)
- Percent change of tumor volume(through study completion, an average of 1 year)
- Maximum percent reduction of tumor volume(through study completion, an average of 1 year)