A First-in-human Trial of GEN3017 in Hodgkin Lymphoma and Non-Hodgkin Lymphoma

NCT06018129 | Terminated Phase 1 Results FDA Drug

• 3 other identifiers: GCT3017-012023-503348-15-00jRCT2031230576
• Study Type: interventional
• Target: 9
• Locations: 2 countries
• Sites: 4

Brief 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.

Conditions

Classical Hodgkin Lymphoma; Non-Hodgkin Lymphoma

Outcome Measures

Primary Outcomes (2)

• Dose Escalation Part: Number of Participants With Dose-Limiting Toxicities (DLTs)

  A DLT was defined as any of the following toxicities except those that were clearly due to the underlying disease or extraneous cause: all Grade 5 toxicities, hematological toxicities (Grade 4 neutropenia, Grade 3 and Grade 4 febrile neutropenia lasting \>2 days, Grade 4 thrombocytopenia of any duration with clinically significant bleeding or ≥ Grade 3 thrombocytopenia requiring platelet transfusion, Grade 4 anemia), non-hematological toxicities (Grade 4 cytokine release syndrome \[CRS\] per American Society for Transplantation and Cellular Therapy \[ASTCT\] criteria or Grade 3 unresolved to ≤ Grade 2 within 48 hours following adequate intervention, Grade 4 immune effector cell-associated neurotoxicity syndrome \[ICANS\] according to ASTCT criteria or Grade 3 unresolved to ≤ Grade 2 within 48 hours following adequate intervention, tumor lysis syndrome \[TLS\] Grade 4 or Grade 3 unresolved within 5 days, any ≥ Grade 3 \[severe or life-threatening\] non-hematological toxicities \[with exceptions\]).

  21 days

• Dose Escalation Part: Number of Participants With Adverse Events (AEs)

  An AE was defined as any untoward medical occurrence in a clinical trial participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE was therefore any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product.

  Up to approximately 1 year 2 months

Secondary Outcomes (12)

• Dose Escalation Part: Maximum (Peak) Plasma Concentration (Cmax) of GEN3017

  Day 1 and Day 8

• Dose Escalation Part: Time to Reach Cmax (Tmax) of GEN3017

  Day 1 and Day 8

• Dose Escalation Part: Pre-dose (Trough) Concentration (Ctrough) of GEN3017

  Day 1 and Day 8

• Dose Escalation Part: Area Under the Concentration-time Curve (AUC) From Time Zero to Infinity (AUCinf) of GEN3017

  Day 1 and Day 8

• Dose Escalation Part: Area Under the Concentration-time Curve (AUC) From Time Zero to Last Quantifiable Sample (AUClast) of GEN3017

  Day 1 and Day 8

Study Arms (2)

R/R CD30+ cHL Cohort

EXPERIMENTAL

Biological: GEN3017

R/R CD30+ TCL Cohort

EXPERIMENTAL

Biological: GEN3017

Interventions

GEN3017 BIOLOGICAL

Subcutaneous injection

Also known as: DuoBody® CD3xCD30

R/R CD30+ TCL Cohort; R/R CD30+ cHL Cohort

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Dose Escalation Part:
• 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:
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Genmab: lead

Study Sites (4)

City of Hope Helford Clinical Research Hospital

Duarte, California, 91010, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Peter MacCallum Cancer Institute trading as Peter MacCallum Cancer Centre

Melbourne, Victoria, Australia

Location

Related Links

• Results Summary in Plain Language

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Limitations and Caveats

Early termination meant only a small number of participants were analyzed and data were not collected for the dose expansion part.

Results Point of Contact

• Title: CLINICAL TRIAL INFORMATION
• Organization: Genmab

clinicaltrials@genmab.com

+45 7020 2728

Study Officials

• Study Official

  Genmab

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2023
• First Posted: August 30, 2023
• Study Start: September 21, 2023
• Primary Completion: February 5, 2025
• Study Completion: February 5, 2025
• Last Updated: September 25, 2025
• Results First Posted: September 23, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1); US (3)