A Phase I, Open-label, Multi-center, Dose Escalation, and Expansion Study of BR101801 in Adult Patients With Advanced Hematologic Malignancies
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 9
- 主要终点
- Number of participants with adverse events (AE) as a measure of safety and tolerability of BR101801 when administered at the MTD or recommended dose (Phase Ia and Ib)
研究概览
简要总结
This is a Phase I, multi-center, open-label, FIH study comprising of 2 study parts (Phase Ia, Phase Ib).
The Phase Ia (dose escalation) part of the study is designed to determine the safety, tolerability, and maximum tolerated dose (MTD)/recommended dose for expansion (RP2D) of BR101801 in subjects with relapsed/refractory B cell lymphoma, chronic lymphocytic leukemia (CLL)/small lymphocytic leukemia (SLL), and peripheral T cell lymphoma (PTCL).
The Phase Ib (dose expansion) part of the study is designed to assess tumor response and safety in specific advanced relapsed/refractory Peripheral T-cell lymphoma(PTCL) at a dose of BR101801 identified in Phase Ia. Once the RP2D has been determined in Phase Ia (dose escalation), Phase Ib (dose expansion) will commence.
详细描述
- Phase Ia (Dose Escalation)
Primary Objectives
- To assess the safety and tolerability of BR101801 in patients with relapsed/refractory B-cell lymphoma, CLL/SLL, and PTCL.
- To assess DLT and to determine the MTD and/or the RDE dose for BR101801 when administered orally on a daily schedule in 4-week cycles until disease progression.
SecondaryObjectives
- To characterize the plasma and urine PK of BR101801.
- To assess the preliminary antitumor activity of BR101801.
- Phase Ib (Dose Expansion)
Primary Objectives
• To assess the safety and tolerability of BR101801 at the RP2D dose in subjects with relapsed/refractory Peripheral T-cell lymphoma (PTCL).
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Treatment (BR101801): Phase Ia (dose escalation)
Patients will receive BR101801 capsules orally, QD in 28-day cycles. The regimen may be changed to BID dosing based on emerging data.
干预措施: BR101801 (Phase Ia) (Drug)
Treatment (BR101801):Phase Ib (dose expansion)
• Subjects with PTCL NOS, PTCL AITL, Nodal PTCL with TFH and PTCL FTCL
干预措施: BR101801 (Phase Ib) (Drug)
结局指标
主要结局
Number of participants with adverse events (AE) as a measure of safety and tolerability of BR101801 when administered at the MTD or recommended dose (Phase Ia and Ib)
时间窗: through study completion, and about average of 1 year
To evaluate safety and tolerability the aggregate review will include but is not limited to: * CTCAE TEAEs, treatment-related TEAEs, Grade 3 or higher TEAEs, Grade 3 or higher treatment-related TEAEs, serious treatment-related TEAEs, and TEAEs leading to death. * Laboratory results; * Vital signs; * ECGs; * Physical examination * ECOG performance status
To determination of the MTD and RDE based on DLTs during Cycle 1 (Phase Ia)
时间窗: From baseline to Week 4
The recommended dose is determined by the number of patients who experience a dose limiting toxicity (DLT).
次要结局
- Cmax(Cycle1( each cycle is 28 days) Day 1 and Cycle 1( each cycle is 28 days) Day 15)
- Ae(Cycle 1( each cycle is 28 days)Day 15, Pre-dose to 12 hours for BID dosing and Pre-dose to 24 hours for QD dosing)
- AUC(0-inf)(Cycle1( each cycle is 28 days) Day 1)
- AUC(0-last)(Cycle1( each cycle is 28 days) Day 1 and Cycle 1( each cycle is 28 days) Day 15, Pre-dose to 24 hours after dosing)
- AUC(0-tau)(Cycle1( each cycle is 28 days) Day 1 and Cycle 1( each cycle is 28 days) Day 15, dosing interval: 24 or 12 hours)