Ensayos clínicos

Key Inclusion Criteria:

1. Must be at least 18 years of age. For participants in the R/R cHL Cohort in the United
States (US) and Australia, must be at least 16 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 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.

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.

Key Exclusion Criteria:

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.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 10/19/23. Questions regarding updates should be directed to the study team contact.