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 - GCT3017-01

Genmab A/S0 个研究点目标入组 240 人开始时间: 2023年7月31日最近更新: 2024年7月22日

适应症

试验速览

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•Dose Escalation: Must be at least 18 years of age. For subjects in the R/R cHL Cohort in the United States (US) and Australia, must be at least 16 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 18 years of age and above. For participants =16 and <18 years of age (US and Australia only), Karnofsky score of >60% per Karnofsky performance scale., Confirmed CD30-positivity in tumor biopsy prior to the first dose of GEN3017., R/R cHL Cohort in Dose Escalation:• 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

•Primary central nervous system (CNS) tumor or known CNS involvement., Received prior investigational CD30-targeting therapy., Autologous 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 GEN3017., Curative radiotherapy within 4 weeks or palliative radiotherapy within 2 weeks prior to the first dose of GEN3017., 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 GEN3017., Receiving immunosuppressive drugs or systemic corticosteroids such as prednisone at doses >25 mg daily or its equivalent within 14 days prior to the first dose of GEN3017. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

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