Phase 1A/1B Trial of BTM-3566 in Relapsed/Refractory Mature B Cell Lymphomas
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 24
- 试验地点
- 3
- 主要终点
- Adverse Event and dose-limiting toxicity event rates
研究概览
简要总结
The goal of this clinical trial is to learn if BMT-3566 can safety be given to adult patients with relapsed or refractory mature b cell lymphomas. It will also learn how well BTM-3566 works to treat relapsed or refractory mature b cell lymphomas. The main questions it aims to answer are:
What are the side effects of BTM-3566 at different doses? What are the levels of BTM-3566 in the blood at different timepoints around dosing? What is the clinical benefit of BTM-3566 in treating cancer (i.e. how well does it slow or stop disease progression)?
Participants will:
Take BTM-3566 in 14-day periods with 7 days of dosing followed by 7 days of no dosing Visit the clinic regularly for checkups and tests Keep a diary of their dosing and weight
详细描述
This is an open label, phase 1 dose escalation trial of BTM-3566 in relapsed/refractory mature b cell lymphomas. Dose escalation will utilize traditional 3+3 methodology to determine the maximum tolerated dose of BTM-3566. Treatment will be given as two-week cycles, with BTM-3566 taken daily during the first week of the cycle, and the second week 'off therapy'. DLT window will be the first two cycles of therapy (days 1 to 28). All enrolled patients will undergo a baseline FDG-PET/CT scan within 3 weeks prior to starting therapy. FDG-PET/CT will be repeated at the start of Cycles 3 and 5 or more frequently as clinically indicated. Beginning at Cycle 5, imaging will be repeated every 3 months (or as clinically indicated) for up to 12 months, and every 6 months thereafter, until disease progression or start of subsequent anti-cancer therapy.
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
- •must be age ≥18 years
- •must have a diagnosis of relapsed or refractory mature B cell lymphoma
- •must have measurable disease per response evaluation criteria in lymphoma (Lugano classification)
- •must have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2
- •must have a predicted life expectancy of ≥3 months
- •must agree to use adequate birth control throughout their participation and for 90 days following the last dose of BTM-3566
排除标准
- •has primary CNS lymphoma
- •has ongoing toxicities from prior anti-cancer treatment > Grade 1
- •has symptomatic or uncontrolled neurologic disease (brain metastases, leptomeningeal disease, or spinal cord compression) not definitively treated with surgery or radiation
- •has received any anti-cancer therapy (including radiation of curative intent) <28 days prior to administration of BTM-3566
- •has current second malignancy at other sites (exceptions: non-melanomatous skin cancer, adequately treated in situ carcinoma, or indolent prostate cancer under observation).
- •is pregnant or breastfeeding
研究组 & 干预措施
BTM-3566 Treatment
BTM-3566 Oral Solution
干预措施: BTM-3566 (Drug)
结局指标
主要结局
Adverse Event and dose-limiting toxicity event rates
时间窗: 24 months
The rate of adverse events and dose-limiting toxicity of therapy with BTM-3566
次要结局
未报告次要终点