jRCT2031230576暂停不适用
A Phase 1/2a, Open-Label, Dose Escalation Trial of GEN3017 With Expansion Cohorts in Relapsed or Refractory CD30+ Classical Hodgkin Lymphoma and CD30+ Non-Hodgkin Lymphoma
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- Genmab
- 入组人数
- 12
- 主要终点
- Incidence of dose-limiting toxicities (DLTs)
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomized Controlled Trial
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Dose Escalation Part:
- •Must be at least 18 years of age.
- •Histologically confirmed R/R cHL or R/R TCL.
- •Participants must have at least 1 measurable lesion by fluorodeoxyglucose-positron emission tomography (FDG-PET) scan demonstrating positive lesion compatible with computed tomography (CT)- or magnetic resonance imaging (MRI)-defined anatomical tumor sites and a CT scan (or MRI) with involvement of >=1 measurable nodal lesion and/or >=1 measurable extranodal lesion.
- •Eastern Cooperative Oncology Group (ECOG) performance status score 0 or 1 for participants.
- •Confirmed CD30-positivity in tumor biopsy prior to the first dose of GEN
- •R/R cHL Cohort:
- •Must have relapsed or progressive cHL after receiving at least 2 or 3 prior lines of therapy; OR
- •Refractory to the second line of therapy.
排除标准
- •Primary central nervous system (CNS) tumor or known CNS involvement.
- •Received prior investigational CD30-targeting therapy.
- •Autologous hematopoietic stem cell transplant (HSCT) within 60 days prior to the first dose of GEN3017 or any prior allogeneic HSCT.
- •Chemotherapy within 2 weeks or major surgery within 4 weeks prior to the first dose of GEN
- •Curative radiotherapy within 4 weeks or palliative radiotherapy within 2 weeks prior to the first dose of GEN
- •Treatment with an investigational drug within 4 weeks or 5 half-lives of the drug, whichever is shorter prior to the first dose of GEN3017 or currently receiving any other investigational agents.
- •Prior treatment with live, attenuated vaccines within 30 days prior to the first dose of GEN
- •8 Receiving immunosuppressive drugs or systemic corticosteroids such as prednisone at doses >25 milligrams (mg) daily or its equivalent within 14 days prior to the first dose of GEN3017.
结局指标
主要结局
Incidence of dose-limiting toxicities (DLTs)
Incidence of dose-limiting toxicities (DLTs)
Incidence and severity of adverse events (AEs)
Incidence and severity of adverse events (AEs)
ORR based on the Lugano criteria as assessed by independent review committee (IRC)
ORR based on the Lugano criteria as assessed by independent review committee (IRC)
次要结局
未报告次要终点
研究者
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