A Phase 1, Open-Label, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Multiple Intravenous Doses of IGN002 Administered Weekly to Subjects With Refractory Non-Hodgkin Lymphoma (NHL)
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 62
- 试验地点
- 4
- 主要终点
- To evaluate the safety and tolerability of multiple doses of IGN002 administered weekly as an intravenous (IV) infusion to subjects with refractory NHL
研究概览
简要总结
A Phase 1, Open-Label, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Multiple Intravenous Doses of IGN002 Administered Weekly to Subjects with Refractory Non-Hodgkin Lymphoma (NHL)
详细描述
This open-label, non-randomized, first-in-human Phase 1 study involves two stages:
In the Dose-Escalation Stage, ascending dose cohorts will be treated in 2 periods until the maximum tolerated dose is identified. In Period 1, subjects will receive 2 doses of IGN002 administered weekly. In Period 2, subjects will receive up to 24 additional doses of IGN002 administered weekly in three 8-week cycles. Subjects that have not progressed following the treatment period will be followed for another 6 months.
In the Expansion Stage, subjects will receive up to 24 doses of IGN002 at the identified maximum tolerated dose administered weekly in three 8-week cycles. Subjects that have not progressed following the treatment period will be followed for another 6 months.
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
- •Documented history of immunohistochemistry (IHC)-confirmed CD20-positive (with no subsequent history of CD20-negativity) B-cell, NHL, including diffuse large B cell (DLBCL), mantle cell, marginal zone, lymphoplasmacytic, follicular, transformed follicular, or primary mediastinal B cell lymphoma
- •Refractory disease, having failed available therapies
- •Measurable disease
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- •Life expectancy > 3 months
- •Adequate organ function
排除标准
- •Treatment with an approved or investigational chemotherapy drug within 28 days of Day 1
- •Treatment with an approved or investigational anti-CD20 drug within 28 days of Day 1
- •Treatment with an approved or investigational biologic drug that does not target CD20 within 90 days of Day 1
- •Radiation therapy within 4 weeks of Day 1
结局指标
主要结局
To evaluate the safety and tolerability of multiple doses of IGN002 administered weekly as an intravenous (IV) infusion to subjects with refractory NHL
时间窗: Weekly for 6 months
Adverse Event collection and assessment will be done for all potentially treated subjects to assess the safety, tolerability, and determine the maximum tolerated dose
次要结局
- To characterize the pharmacokinetic (PK) profile of ascending doses of IGN002 administered weekly(Weekly for 6 months)
- To assess the anti-tumor activity of IGN002 using the Lugano Classification for NHL(Every 8 weeks for 6 months, then at 1, 3 and 6 months)