Status:
TERMINATED
A First-in-human Trial of GEN3017 in Hodgkin Lymphoma and Non-Hodgkin Lymphoma
Lead Sponsor:
Genmab
Conditions:
Classical Hodgkin Lymphoma
Non-Hodgkin Lymphoma
Eligibility:
All Genders
16+ years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this trial is to evaluate the safety, tolerability, immunogenicity, pharmacokinetics (PK), pharmacodynamics (PD), and anti-tumor activity of GEN3017 as a monotherapy in participants wit...
Detailed Description
This multicenter trial will be conducted in 2 parts: Dose Escalation (phase 1) and Expansion (phase 2a). The Dose Escalation Part (phase 1) of the trial will evaluate dose-limiting toxicities (DLTs) ...
Eligibility Criteria
Inclusion
- Key
- Dose Escalation Part:
- 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.
- 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:
- 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
- Primary central nervous system (CNS) tumor or known CNS involvement.
- Received prior investigational CD30-targeting therapy (except brentuximab vedotin).
- Autologous hematopoietic stem cell transplant (HSCT) within 60 days (applies to both cHL and TCL). Allogeneic HSCT within 90 days (applies to cHL) prior to the first dose of GEN3017.
- 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 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.
Key Trial Info
Start Date :
September 21 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 5 2025
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT06018129
Start Date
September 21 2023
End Date
February 5 2025
Last Update
September 25 2025
Active Locations (4)
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1
City of Hope Helford Clinical Research Hospital
Duarte, California, United States, 91010
2
Washington University School of Medicine
St Louis, Missouri, United States, 63110
3
MD Anderson Cancer Center
Houston, Texas, United States, 77030
4
Peter MacCallum Cancer Institute trading as Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia