A Phase I, Open-label, Dose Escalation Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of ONO-7018 in Patients With Relapsed or Refractory NHL or CLL
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 9
- 试验地点
- 21
- 主要终点
- Estimate of Maximum Tolerated Dose (MTD)
研究概览
简要总结
This is a Phase 1, open-label, multicenter study. This will be the first-in-human clinical study for ONO-7018 and will be conducted in two phases: a Dose Escalation Phase (Part 1) and a Dose Expansion Phase (Part 2).
详细描述
ONO-7018 is a selective inhibitor of mucosa associated lymphoid tissue protein 1 (MALT1) and is expected to exhibit antitumor activity in NHL and CLL. The purpose of this study is to determine the MTD and to evaluate the safety, tolerability, PK, pharmacodynamics (biomarkers), and efficacy of ONO-7018 in patients with relapsed or refractory NHL or CLL.
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
- •Patient aged ≥ 18 years
- •Written informed consent by the patient or the patient's legally authorized representative
- •Patient with histologically/cytologically confirmed diagnosis of NHL or CLL
- •Patient with relapsed or refractory disease who has no available therapeutic options known to provide clinical benefit
- •Patient who has measurable disease
- •All acute toxic effects of any prior antitumor therapy, including investigational therapy, resolved to Grade ≤ 1 before the start of study therapy
- •Eastern Cooperative Oncology Group Performance Status 0 to 2
- •Adequate bone marrow, renal and hepatic functions
排除标准
- •History of lymphoid malignancy other than those allowed per inclusion criteria
- •Patient with central nervous system involvement
- •Patient with systemic and active infection
- •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
- •Prior treatment with a MALT1 inhibitor
- •Patient receiving any other investigational drug within 4 weeks prior to study entry
- •Patient is unable to swallow tablets
- •Patient is found to be otherwise ineligible for the study by the investigator or sub investigator
研究组 & 干预措施
Dose Escalation Phase (Part 1)
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)
Dose Expansion Phase (Part 2)
Eligible patients will be assigned to the recommended dose level(s) selected from Part 1.
干预措施: ONO-7018 (Drug)
结局指标
主要结局
Estimate of Maximum Tolerated Dose (MTD)
时间窗: Up to 3 weeks
MTD will be estimated based on Dose limiting toxicity (DLT) observed during the first 3 weeks of treatment
Incidence, causality, and severity of Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
时间窗: Through study completion, an average of 1 year
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
- Antitumor Activity of ONO-7018 (Overall Response Rate [ORR])(Through study completion, an average of 1 year)
- Plasma Concentration of ONO-7018(Up to 48 weeks)
- Antitumor Activity of ONO-7018 (Duration of Response [DOR])(Through study completion, an average of 1 year)
- Antitumor Activity of ONO-7018 (Overall Survival [OS])(Through study completion, an average of 1 year)
- Antitumor Activity of ONO-7018 (Progression Free Survival [PFS])(Through study completion, an average of 1 year)