A First-in-human Trial of GEN3017 in Hodgkin Lymphoma and Non-Hodgkin Lymphoma
Sponsor: Genmab
ClinicalTrials ID:NCT06018129
This trial assesses GEN3017's safety, tolerability, and efficacy in R/R CD30+ lymphomas. Conducted in two parts, it involves dose escalation to determine RP2D and expansion to evaluate anti-tumor activity. Eligible participants are 16+ with confirmed CD30+ tumors. Exclusions include prior CD30 therapy and recent HSCT. GEN3017 is administered via subcutaneous injection.
Patient Parameters
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Program Overview
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.
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) 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).
Eligibility Criteria
Inclusion Criteria
Dose Escalation Part:
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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.
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Histologically confirmed R/R cHL or R/R TCL.
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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.
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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.
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Confirmed CD30-positivity in tumor biopsy prior to the first dose of GEN3017.
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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 Criteria
- 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.
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