JPRN-jRCT2031230576招募中1 期
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
Seki Hidekuni0 个研究点目标入组 12 人开始时间: 2024年1月18日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Dose Escalation Part:
- •1. Must be at least 18 years of age.
- •2. Histologically confirmed R/R cHL or R/R TCL.
- •3. 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.
- •4. Eastern Cooperative Oncology Group (ECOG) performance status score 0 or 1 for participants.
- •5. Confirmed CD30-positivity in tumor biopsy prior to the first dose of GEN3017.
- •6. 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
- •1. Primary central nervous system (CNS) tumor or known CNS involvement.
- •2. Received prior investigational CD30-targeting therapy.
- •3. Autologous hematopoietic stem cell transplant (HSCT) within 60 days prior to the first dose of GEN3017 or any prior allogeneic HSCT.
- •4. Chemotherapy within 2 weeks or major surgery within 4 weeks prior to the first dose of GEN3017.
- •5. Curative radiotherapy within 4 weeks or palliative radiotherapy within 2 weeks prior to the first dose of GEN3017.
- •6. 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.
- •7. Prior treatment with live, attenuated vaccines within 30 days prior to the first dose of GEN3017.
- •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.
研究者
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