A First-in-human Trial of GEN3017 in Hodgkin Lymphoma and Non-Hodgkin Lymphoma
NCT ID: NCT06018129
Last Updated: 2025-09-25
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE1/PHASE2
9 participants
INTERVENTIONAL
2023-09-21
2025-02-05
Brief Summary
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GEN3017 will be administered via subcutaneous injections.
All participants will receive active drug; no one will be given placebo.
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Detailed Description
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The Dose Escalation Part (phase 1) of the trial will evaluate dose-limiting toxicities (DLTs) to determine the recommended phase 2 dose (RP2D), and if reached, the maximum tolerated dose (MTD) for R/R CD30+ classical Hodgkin lymphoma (cHL) and R/R CD30+ T-cell lymphoma (TCL), respectively.
The Expansion Part (phase 2a) will evaluate the anti-tumor activity of GEN3017 at the RP2D and selected dosage(s) will be assessed together with safety, immunogenicity, pharmacokinetics, and pharmacodynamics in R/R CD30+ cHL participants (including adults; and adolescent and young adults) and in participants with selected R/R CD30+ TCL subtypes (adults only).
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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R/R CD30+ cHL Cohort
GEN3017
Subcutaneous injection
R/R CD30+ TCL Cohort
GEN3017
Subcutaneous injection
Interventions
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GEN3017
Subcutaneous injection
Other Intervention Names
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Eligibility Criteria
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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.
Exclusion Criteria
2. Received prior investigational CD30-targeting therapy (except brentuximab vedotin).
3. 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.
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.
16 Years
ALL
No
Sponsors
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Genmab
INDUSTRY
Responsible Party
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Principal Investigators
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Study Official
Role: STUDY_DIRECTOR
Genmab
Locations
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City of Hope Helford Clinical Research Hospital
Duarte, California, United States
Washington University School of Medicine
St Louis, Missouri, United States
MD Anderson Cancer Center
Houston, Texas, United States
Peter MacCallum Cancer Institute trading as Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Results Summary in Plain Language
Other Identifiers
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2023-503348-15-00
Identifier Type: CTIS
Identifier Source: secondary_id
jRCT2031230576
Identifier Type: REGISTRY
Identifier Source: secondary_id
GCT3017-01
Identifier Type: -
Identifier Source: org_study_id
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