A Phase I/II，Multicenter, Open-Label, Study of a Novel Bruton's Tyrosine Kinase Inhibitor, Orelabrutinib, in Patients With B-Cell Malignancies
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 81
- 试验地点
- 65
- 主要终点
- Part 1 Dose Escalation：The maximum tolerated dose (MTD)
研究概览
简要总结
This is a Phase I/II, multicenter, open-label study to evaluate the safety, efficacy, tolerability, and pharmacokinetics of a novel BTK inhibitor, Orelabrutinib (ICP-022) in Patients with B-cell malignancies. The study contains two parts, Part 1 (dose escalation) and Part 2 (dose expansion).
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
- •Signed Informed Consent.
- •Age ≥ 18 years.
- •Part 1: Patients with histologically confirmed relapsed or refractory B-cell malignancies, including Grades 1-3a FL, MZL, MCL, and CLL/SLL.
- •Part 2: Patients with histologically confirmed B-cell malignancies including r/r FL, r/r MZL and CLL/SLL with/without prior treatment.
- •Life expectancy (in the opinion of the investigator) of ≥ 4 months.
- •ECOG performance status of 0 ~
- •Must have adequate organ function.
- •Negative test results for HBV ([HBsAg (-)] and non-active HBV or HCV infection
排除标准
- •Pregnant or breast-feeding or intending to become pregnant during the study.
- •Prior treatment with systemic immunotherapeutic agents.
- •Known allergies to Orelabrutinib (ICP-022) or its excipients or infection with HIV.
- •Treatment with any chemotherapeutic agent, or any other investigational therapies within 4 weeks prior to first dose of the study drug.
- •History of allogeneic stem-cell (or other organ) transplantation or confirmed progressive PML.
- •Any external beam radiation therapy within 6 weeks prior to the first dose of the study drug.
- •Concurrent use of warfarin or other vitamin K antagonists or anticoagulation therapies or strong CYP3A inhibitor.
- •Active uncontrolled infections.
- •Recent infection requiring IV anti-infective treatment that was completed ≤ 14 days before the first dose of study drug.
- •Unresolved toxicities from prior anti-cancer therapy.
- •Medically apparent CNS lymphoma or leptomeningeal disease.
- •Current or previous history of CNS disease.
- •Major surgery or significant traumatic injury < 28 days prior to the first dose of the study drug.
- •Patients with another invasive malignancy in the last 2 years.
- •Significant cardiovascular disease or active pulmonary disease.
- •Received systemic immunosuppressive medications.
研究组 & 干预措施
Part 1 Dose Escalation
Patients with r/r B-cell malignancies including Grades 1-3a FL, MZL, MCL, and CLL/SLL
干预措施: Orelabrutinib (ICP-022) (Drug)
Part 2 Dose Expansion
Arm 1: Patients with r/r MCL
Arm 2: Patients with other types of B-cell malignancies, including:
- CLL/SLL with/without prior treatment
- r/r FL
- r/r MZL
干预措施: Orelabrutinib (ICP-022) (Drug)
结局指标
主要结局
Part 1 Dose Escalation：The maximum tolerated dose (MTD)
时间窗: Incidence of dose limiting toxicities (DLTs) up to 28 days
To determine the maximum tolerated dose (MTD)
Part 2 Dose Expansion：ORR
时间窗: Up to 2 years
To assess anti-tumor activity of Orelabrutinib (ICP-022) in Patients with B-cell malignancies including r/r MCL, r/r FL, r/r MZL and CLL/SLL with/without prior treatment.
次要结局
- Part 1 Dose Escalation：T1/2(Up to 2 years)
- Part 2 Dose Expansion：Incidence and severity of treatment-emergent adverse events (AEs) [Safety and Tolerability](Up to 2 years)
- Part 1 Dose Escalation：ORR(Up to 2 years)
- Part 2 Dose Expansion：DOR(Up to 2 years)
- Part 1 Dose Escalation：Incidence and severity of treatment-emergent adverse events (AEs) [Safety and Tolerability](Up to 2 years)