A first-in-human trial of safety and efficacy of GEN3017 in subjects with Hodgkin lymphoma or non-Hodgkin lymphoma

Prior treatment

• 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.

Other

• Primary central nervous system (CNS) tumor or known CNS involvement.

• 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