A First-in-human Trial of GEN3017 in Hodgkin Lymphoma and Non-Hodgkin Lymphoma

JRCT ID: jRCT2031230576

Registered date:18/01/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Classical Hodgkin Lymphoma and Non-Hodgkin Lymphoma
• Date of first enrollment: 01/10/2024
• Target sample size: 12
• Countries of recruitment: USA,Japan,Australia,Japan,Denmark,Japan,France,Japan,Germany,Japan,Italy,Japan,Netherlands,Japan
• Study type: Interventional
• Intervention(s): Biological: GEN3017

Outcome(s)

Primary Outcome

- Incidence of dose-limiting toxicities (DLTs)
- Incidence and severity of adverse events (AEs)
- ORR based on the Lugano criteria as assessed by independent review committee (IRC)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

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.

Exclude 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.

Related Information

• Primary Sponsor: Seki Hidekuni
• Secondary ID(s): NCT06018129