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
- 2
- 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
研究组 & 干预措施
Dose Escalation Stage/ Expansion Stage
The Dose-Escalation Stage will employ a modified 3 + 3 cohort design, subjects will receive up to 26 doses of IGN002.
In the Expansion Stage, subjects will receive up to 24 doses of IGN002 at the maximum tolerated dose administered weekly in three 8-week cycles.
干预措施: IGN002 (Biological)
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)