A Phase 1 Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Antitumor Activity of LAVA-051 in Patients with Relapsed or Refractory CLL, MM, or AML
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 16
- 试验地点
- 14
- 主要终点
- Part 1 & Part 2 - Frequency and severity of AEs:
研究概览
简要总结
A phase 1, first-in-human trial to evaluate the safety and tolerability of LAVA-051 in patients with relapsed or refractory Chronic Lymphocytic Leukemia (CLL), Multiple Myeloma (MM), or Acute Myeloid Leukemia (AML).
详细描述
An open-label, phase 1 dose escalation trial with disease-specific expansion cohorts to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary anti-tumor activity of LAVA-051 in patients with relapsed or refractory CLL, MM, or AML.
The trial was intended to be a Phase 1/2 trial (but the trial never moved forward to Phase 2).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
LAVA-051
Part 1 (dose escalation): LAVA-051 will be given to patients via intravenous (IV) infusion with dose escalation. A selected group of patients will also receive a low dose of interleukin 2 via subcutaneous injection.
- Group A: LAVA-051
- Group B: LAVA-051 + low dose interleukin 2
Part 2 (dose expansion): patients will receive LAVA-051 at the dose and regimen established in Part 1 of the study
干预措施: LAVA-051 (Biological)
LAVA-051
Part 1 (dose escalation): LAVA-051 will be given to patients via intravenous (IV) infusion with dose escalation. A selected group of patients will also receive a low dose of interleukin 2 via subcutaneous injection.
- Group A: LAVA-051
- Group B: LAVA-051 + low dose interleukin 2
Part 2 (dose expansion): patients will receive LAVA-051 at the dose and regimen established in Part 1 of the study
干预措施: Interleukin 2 (Biological)
结局指标
主要结局
Part 1 & Part 2 - Frequency and severity of AEs:
时间窗: Approximately 6 months
Frequency, severity, and grading of Adverse Events using the Common Terminology Criteria and grading for Adverse Events (CTCAE) v5.0. CRS will be evaluated using the ASTCT.
Part 1 - Frequency and type of DLT
时间窗: First 28 days of treatment
A DLT is defined as an adverse event that is unrelated to disease progression, intercurrent illness, or concomitant medications and is occurring during the first 28 days of treatment. These events will be classified according to the CTCAE v5.0; CRS will be evaluated according to the ASTCT consensus criteria
次要结局
- Part 1 & Part 2: Pharmacokinetics of LAVA-051, area under the plasma concentration versus time curve (AUC)(Approximately 6 months)
- Part 1 & Part 2: Number of participants with an antitumor response(Approximately 6 months)
- Part 1 & Part 2: Incidence and prevalence anti-LAVA-051 antibodies(Approximately 6 months)