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RecruitingLast updated: 4 January 2024

This study is evaluating how safe, tolerable and effective a new drug (called GEN3017) is when given to people with relapsed or refractory CD30-expressing lymphomasA Phase 1/2a, Open-Label, Dose Escalation Trial of GEN3017 With Expansion Cohorts in Relapsed or Refractory CD30+ Classical Hodgkin Lymphoma and CD30+ Non-Hodgkin Lymphoma

Clinical summary


This study will be conducted in 2 parts (Dose Escalation and Expansion) and will be evaluating a new drug, called GEN3017, in people with relapsed/refractory (R/R) CD30+ classical Hodgkin lymphoma (cHL) and R/R CD30+ T-cell lymphoma.

The Dose Escalation part of the study will evaluate how safe and tolerable GEN3017 is, and aims to determine the recommended phase 2 dose (RP2D) and, if reached, the maximum tolerated dose (MTD).

The Expansion Part will further evaluate the safety and effectiveness of GEN3017 at the RP2D identified in the Dose Escalation part, and at other selected doses. 



This trial is treating patients with CD30+ classical Hodgkin lymphoma and T-cell lymphoma


Blood Cancers Haematological





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Trial Identifiers

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Trial sponsor


Scientific Title

A Phase 1/2a, Open-Label, Dose Escalation Trial of GEN3017 With Expansion Cohorts in Relapsed or Refractory CD30+ Classical Hodgkin Lymphoma and CD30+ Non-Hodgkin Lymphoma



Dose Escalation Part:

  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.


  1. Primary central nervous system (CNS) tumor or known CNS involvement.
  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.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.


  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have had treatment, but your cancer has come back.


  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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