NCT04414163进行中（未招募）2 期
An Open-label, Single-arm, Phase 2 Study to Investigate the Efficacy and Safety of IMC-001 in Patients With Relapsed or Refractory Extranodal NK/T Cell Lymphoma, Nasal Type
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 23
- 试验地点
- 10
- 主要终点
- Occurrence of Objective Response Rate(ORR)
研究概览
简要总结
This is a phase 2, Open-label, to investigate the efficacy and safety of IMC-001 in patients with Relapsed or Refractory extranodal NK/T cell lymphoma, nasal type
详细描述
IMC-001 is a PD-L1 targeting, fully human monoclonal antibody. The purpose of this study is to determine and evaluate the efficacy and safety of IMC-001. 20mg/kg every 2 weeks, IV infusion of IMC-001 will be tested in subjects with Relapsed or Refractory extranodal NK/T cell lymphoma, nasal type.
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
- •ENKTL diagnosis;
- •Histologically confirmed diagnosed with extranodal NK/T-cell lymphoma, nasal type
- •At least 1 previous line of systemic therapy
- •Documented disease progression of last therapy
- •Adult age(as defined by respective country)
- •The nature of the study and voluntarily sign an ICF
- •Adequate hematologic function, hepatic function, and renal function
排除标准
- •Previously treated with an anti-PD-L1 or anti-PD-1 antibody
- •Known presence of symptomatic CNS metastases
- •Prior allogeneic HSCT or solid organ transplantation
- •Any active autoimmune disease or a documented history of autoimmune disease
- •Apparent active or latent TB and known viral infection with hepatitis B virus or hepatitis C virus
- •Pregnant or lactating
研究组 & 干预措施
IMC-001
Experimental
Single Dose level (IMC-001 20mg/kg, every 2 weeks)
干预措施: IMC-001 (Drug)
结局指标
主要结局
Occurrence of Objective Response Rate(ORR)
时间窗: through study completion, an average of 1 year
Lugano criteria with LYRIC modification
次要结局
- Evaluate safety of IMC-001(through study completion, an average of 1 year)
- Evaluate additional efficacy variables of IMC-001 : Complete Response (CR) rate(The imaging assessment will be performed every 12 weeks (± 1 week) according to the Lugano criteria with LYRIC modification by centralized independent review, and the Lugano criteria with LYRIC modification and the Lugano Criteria by investigator.)
- Evaluate additional efficacy variables of IMC-001 : Disease Control Rate (DCR)(The imaging assessment will be performed every 12 weeks (± 1 week) according to the Lugano criteria with LYRIC modification by centralized independent review, and the Lugano criteria with LYRIC modification and the Lugano Criteria by investigator.)
- Evaluate additional efficacy variables of IMC-001 : Progression-Free Survival (PFS)(The imaging assessment will be performed every 12 weeks (± 1 week) according to the Lugano criteria with LYRIC modification by centralized independent review, and the Lugano criteria with LYRIC modification and the Lugano Criteria by investigator.)
- Evaluate additional efficacy variables of IMC-001 : Duration of Response (DOR)(The imaging assessment will be performed every 12 weeks (± 1 week) according to the Lugano criteria with LYRIC modification by centralized independent review, and the Lugano criteria with LYRIC modification and the Lugano Criteria by investigator.)
- Evaluate additional efficacy variables of IMC-001 : Time to Progression (TTP)(The imaging assessment will be performed every 12 weeks (± 1 week) according to the Lugano criteria with LYRIC modification by centralized independent review, and the Lugano criteria with LYRIC modification and the Lugano Criteria by investigator.)
- Evaluate additional efficacy variables of IMC-001 : Overall Response Rate (ORR)(The imaging assessment will be performed every 12 weeks (± 1 week) according to the Lugano criteria with LYRIC modification by centralized independent review, and the Lugano criteria with LYRIC modification and the Lugano Criteria by investigator.)
- Evaluate additional efficacy variables of IMC-001 : Overall Survival (OS)(through study completion, an average of 1 year)
- Determine the pharmacokinetic (PK) profile of IMC-001 : Ctrough(Cycle 1 Day 1(Pre-dose/EOI + 1 hr ± 5 min), Cycle 2, 4, 7, 10, 13 Day 1(Pre-dose up to 1 hr before/EOI + 1 hr ± 5 min) (each cycle is 14 days))
- Determine the pharmacokinetic (PK) profile of IMC-001 : Cmax(Cycle 1 Day 1(Pre-dose/EOI + 1 hr ± 5 min), Cycle 2, 4, 7, 10, 13 Day 1(Pre-dose up to 1 hr before/EOI + 1 hr ± 5 min) (each cycle is 14 days))
- Characterize the immunogenicity of IMC-001 : Incidence of Anti-Drug Antibodies (ADA)(Screening, prior to infusion at Cycle 4, 7, 10, and 13, End of Treatment, Safety Follow up (each cycle is 14 days, EOT: 28-day (+ 3 days) after the last dose of study drug, Safety Follow up: 90-day (±7 days) after the end-of treatment visit))
- Characterize the immunogenicity of IMC-001 : Correlation Between ADA and Drug Exposure and Activity(Screening, prior to infusion at Cycle 4, 7, 10, and 13, End of Treatment, Safety Follow up (each cycle is 14 days, EOT: 28-day (+ 3 days) after the last dose of study drug, Safety Follow up: 90-day (±7 days) after the end-of treatment visit))
研究者
研究点 (10)
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