A Phase 1/2, Open-Label, Multicenter Trial Investigating the Safety, Tolerability, and Preliminary Antineoplastic Activity of IPH6501 in Patients With Relapsed and/or Refractory CD20-expressing Non-Hodgkin Lymphoma
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 23
- 试验地点
- 18
- 主要终点
- Safety and tolerability
研究概览
简要总结
This is an international, first-in-human, multicenter, open-label Phase 1/2 study to evaluate the safety profile, tolerability of IPH6501, and determine the recommended phase 2 dose (RP2D) for patients with B-Cell non-Hodgkin lymphoma.
详细描述
In Phase 1 - Dose finding, patients with advanced histologically confirmed, documented CD20+ B-cell non-Hodgkin lymphoma (NHL) will be enrolled. The dose finding part will include 2 sub-parts: Dose escalation will determine the Maximum Tolerated Dose (MTD) or the highest tested dose, Dose assessment will determine RP2D.
In Phase 2 - Dose expansion, one or more cohorts will be selected with patients with subtypes of advanced histologically confirmed, documented CD20+ B-cell non-Hodgkin lymphoma.
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 64 years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Main Inclusion criteria
- •Patients with advanced histologically confirmed, documented CD20+ B-cell non-Hodgkin's lymphoma (NHL) including the following types defined by WHO 2016: Diffuse Large B Cell Lymphoma (DLBCL); high grade; thymic; Follicular Lymphoma (FL); Mantle cell lymphoma (MCL); Marginal zone lymphoma (MZL)
- •Relapsed, progressive and/or refractory disease without established alternative therapy
- •Must have received at least 2 prior systemic therapies including at a minimum anti-CD20 antibody therapy (e.g., rituximab) potentially in combination with chemotherapy and/or relapsed after autologous stem cell rescue.
- •Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
- •Adequate organ and hematological function
- •Able to provide a fresh biopsy from a safely accessible site (or historical biopsy), per investigator determination.
排除标准
- •Patients with another invasive malignancy in the last 2 years
- •Prior chemotherapy, immunotherapy or other anti-cancer therapy within less than 4 weeks before study drug administration.
- •Autologous stem cell transplant or treatment with CAR-T (Chimeric Antigen Receptor T-Cell) cell therapy within 100 days prior to first dose of study drug
- •Subjects with brain or subdural metastases are not eligible, nor those with history of central nervous system (CNS) lymphoma
- •Current or past history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease.
- •Known history of infection with human immunodeficiency virus (HIV) or hepatitis B or C
- •Major surgery within 4 weeks before the first dose of study drug
- •Comorbidities including diabetes, cardiovascular diseases, immunodeficiencies/autoimmune condition
- •Pregnant / breastfeeding woman
研究组 & 干预措施
IPH6501 monotherapy
干预措施: IPH6501 (Drug)
结局指标
主要结局
Safety and tolerability
时间窗: From time of informed consent through treatment period and including the follow-up: up to 22 months
To evaluate the safety profile (including dose limiting toxicities (DLT(s), the maximum tolerated dose (MTD) or highest tested dose), tolerability and determine the recommended phase 2 dose (RP2D)
MTD or highest tested dose evaluation
MTD or highest tested dose evaluation
Safety and tolerability analysis
Safety and tolerability analysis
次要结局
- Objective Response Rate (ORR)(From time of informed consent through treatment period and including the follow-up: up to 22 months)
- Duration Of Response (DoR)(From time of informed consent through treatment period and including the follow-up: up to 22 months)
- Progression Free Survival (PFS)(From time of informed consent through treatment period and including the follow-up: up to 22 months)
- Maximum Observed Plasma Concentration (Cmax)(From time of informed consent through treatment period and including the follow-up: up to 22 months)
- Area Under the Plasma Concentration (AUC)(From time of informed consent through treatment period and including the follow-up: up to 22 months)
- Incidence of antidrug antibodies (ADA) against IPH6501(From time of informed consent through treatment period and including the follow-up: up to 22 months)
- Efficacy analysis
- Pharmacokinetics and Immunogenicity analysis