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RecruitingLast updated: 1 December 2023

This study is evaluating how safe, tolerable and effective a new drug (called GEN3017) is in 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

Trial purpose

Medical clipboardCancer treatment

Tumor type

Blood Cancers Haematological

Age

People16+

Clinical summary

Summary

This study will be conducted in 2 parts: Dose Escalation (phase 1) and Expansion (phase 2a).

In the Dose Escalation Part (phase 1), eligible participants with relapsed or refractory (R/R) CD30+ classical Hodgkin lymphoma  and R/R CD30+ T-cell lymphoma will receive the study drug GEN3017 as an injection under the skin. This part of the study aims to determine the recommended phase 2 dose (RP2D), and if reached, the maximum tolerated dose (MTD).

In the Expansion Part (phase 2a), the safety and effectiveness of GEN3017 will further be evaluated at the RP2D identified in the first part and selected dosage(s) in people with R/R CD30+ classical Hodgkin Lymphoma and in people with selected R/R CD30+ T-cell lymphoma subtypes.

Conditions

This trial is treating people with relapsed or refractory classical Hodgkin Lymphoma or T-cell lymphoma

Eligibility

Inclusion

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.

Exclusion

Key Exclusion 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.

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

Inclusion

  • You have had a certain type of treatment or surgical procedure.
  • 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 (relapsed or recurrent).

Exclusion

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

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

  • GCT301701; GCT3017-01; 2023-503348-15-00

Trial sponsor

Genmab

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

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