A Phase 1 Pharmacokinetic and Pharmacodynamic Study of TG-1701, an Irreversible Bruton's Tyrosine Kinase Inhibitor, in Patients With B-Cell Malignancies
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 172
- 试验地点
- 1
- 主要终点
- Maximum Tolerated Dose acceptable for participants
研究概览
简要总结
This is a Phase 1 trial to evaluate the safety, pharmacokinetics and efficacy of TG-1701, a Bruton's Tyrosine Kinase (BTK) inhibitor in patients with relapsed or refractory B-cell malignancies.
详细描述
This Phase I clinical trial aims to evaluate the safety of the investigational drug TG-1701 both as a single-agent and in combination with other investigational drugs, specifically ublituximab and umbralisib. As per protocol v6.0, combination therapy (TG-1701 + Ublituximab + Umbralisib) will be discontinued and the participants from Arm 1 and 2 will be transitioned to the long-term extension period to receive TG-1701 monotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Relapsed or refractory histologically confirmed B-cell lymphoma or CLL
- •Eastern Cooperative Oncology Group (ECOG) score of 0 to 2
- •Adequate organ function
排除标准
- •Prior therapy with a BTK inhibitor (ibrutinib, acalabrutinib, other)
- •Any major surgery, chemotherapy or immunotherapy within the last 21 days
- •Known hepatitis B virus, hepatitis C virus or HIV infection
研究组 & 干预措施
Arm 1: TG-1701 Monotherapy
Participants will receive TG-1701 oral daily dose. As per protocol v6.0, participants from this arm will be transitioned to the long-term extension arm to receive TG-1701 monotherapy.
干预措施: TG-1701 (Drug)
Arm 2: TG-1701 + Ublituximab + Umbralisib
Participants will receive TG-1701, oral dose in combination with ublituximab, oral dose and umbralisib, fixed IV infusion on specific Days of Cycles 1 and 2, followed by maintenance infusions in Cycles 3 to 6 (Cycle=28 days). As per protocol v6.0, participants from this arm will be transitioned to the long-term extension arm to receive TG-1701 monotherapy.
干预措施: TG-1701 (Drug)
Arm 2: TG-1701 + Ublituximab + Umbralisib
Participants will receive TG-1701, oral dose in combination with ublituximab, oral dose and umbralisib, fixed IV infusion on specific Days of Cycles 1 and 2, followed by maintenance infusions in Cycles 3 to 6 (Cycle=28 days). As per protocol v6.0, participants from this arm will be transitioned to the long-term extension arm to receive TG-1701 monotherapy.
干预措施: Umbralisib (Drug)
Arm 2: TG-1701 + Ublituximab + Umbralisib
Participants will receive TG-1701, oral dose in combination with ublituximab, oral dose and umbralisib, fixed IV infusion on specific Days of Cycles 1 and 2, followed by maintenance infusions in Cycles 3 to 6 (Cycle=28 days). As per protocol v6.0, participants from this arm will be transitioned to the long-term extension arm to receive TG-1701 monotherapy.
干预措施: Ublituximab (Biological)
Arm 3: Long Term Safety Extension - TG-1701 Monotherapy
All the ongoing participants from Arm 1 and 2, will be transitioned to TG-1701 monotherapy in long-term extension period, per protocol version 6.0.
干预措施: TG-1701 (Drug)
结局指标
主要结局
Maximum Tolerated Dose acceptable for participants
时间窗: From first dose up to 30 days post last dose (Up to approximately 4.8 years)
To determine the incidence of adverse events, any potential abnormal laboratory results and any dose-limiting toxicities.
次要结局
- Overall Response Rate(Up to approximately 4.8 years)