A First-in-human Trial of GEN3017 in Hodgkin Lymphoma and Non-Hodgkin Lymphoma (NCT06018129) | Clinical Trial Compass
TerminatedPhase 1/2
A First-in-human Trial of GEN3017 in Hodgkin Lymphoma and Non-Hodgkin Lymphoma
Stopped: Genmab discontinued GEN3017 program following a strategic re-evaluation of Genmab's portfolio.
United States, Australia9 participantsStarted 2023-09-21
Plain-language 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 with relapsed or refractory (R/R) CD30-expressing lymphomas.
GEN3017 will be administered via subcutaneous injections.
All participants will receive active drug; no one will be given placebo.
Who can participate
Age range16 Years
SexALL
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Inclusion criteria
✓. 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:
Exclusion criteria
✕. Primary central nervous system (CNS) tumor or known CNS involvement.
✕
What they're measuring
1
Dose Escalation Part: Number of Participants With Dose-Limiting Toxicities (DLTs)
Timeframe: 21 days
2
Dose Escalation Part: Number of Participants With Adverse Events (AEs)
. 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.