Classical Hodgkin LymphomaPhase 1/2NCT06018129
A First-in-human Trial of GEN3017 in Hodgkin Lymphoma and Non-Hodgkin Lymphoma
A Phase 1/2 study testing GEN3017 in people with Classical Hodgkin Lymphoma and Non-Hodgkin Lymphoma, run by Genmab at 4 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Classical Hodgkin Lymphoma, Non-Hodgkin Lymphoma
- What is being tested?
- GEN3017
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 21 Sep 2023to 5 Feb 2025
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
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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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States3 sites
City of Hope Helford Clinical Research Hospital
Duarte, California, 91010
MD Anderson Cancer Center
Houston, Texas, 77030
Washington University School of Medicine
St Louis, Missouri, 63110
Australia1 site
Peter MacCallum Cancer Institute trading as Peter MacCallum Cancer Centre
Melbourne, Victoria
About this study
Official 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
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.
Read the detailed 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).
- Conditions
- Classical Hodgkin Lymphoma, Non-Hodgkin Lymphoma
- Being tested
- GEN3017
- Medical subject headings
- Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GEN3017Biological
Also called DuoBody® CD3xCD30
Subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| R/R CD30+ cHL Cohort | Experimental | Not described Receives: Biological: GEN3017 |
| R/R CD30+ TCL Cohort | Experimental | Not described Receives: Biological: GEN3017 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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]).
Measured: 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.
Measured: Up to approximately 1 year 2 months
Secondary outcomes (12)
Dose Escalation Part: Maximum (Peak) Plasma Concentration (Cmax) of GEN3017
Venous blood samples were collected for analyzing concentrations of GEN3017.
Measured: Day 1 and Day 8
Dose Escalation Part: Time to Reach Cmax (Tmax) of GEN3017
Venous blood samples were collected for analyzing concentrations of GEN3017.
Measured: Day 1 and Day 8
Dose Escalation Part: Pre-dose (Trough) Concentration (Ctrough) of GEN3017
Venous blood samples were collected for analyzing concentrations of GEN3017.
Measured: Day 1 and Day 8
Dose Escalation Part: Area Under the Concentration-time Curve (AUC) From Time Zero to Infinity (AUCinf) of GEN3017
Venous blood samples were collected for analyzing concentrations of GEN3017.
Measured: 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
Venous blood samples were collected for analyzing concentrations of GEN3017.
Measured: Day 1 and Day 8
Dose Escalation Part: Elimination Half-life (T1/2) of GEN3017
Venous blood samples were collected for analyzing concentrations of GEN3017.
Measured: Day 1 and Day 8
Dose Escalation Part: Total Body Clearance (CL) of Drug From Plasma of GEN3017
Venous blood samples were collected for analyzing concentrations of GEN3017.
Measured: Day 1 and Day 8
Dose Escalation Part: Volume of Distribution (Vd) of GEN3017
Venous blood samples were collected for analyzing concentrations of GEN3017.
Measured: Day 1 and Day 8
Dose Escalation Part: Number of Participants With Anti-drug Antibodies (ADAs) to GEN3017
Venous blood samples were drawn for analysis of ADAs in serum samples.
Measured: Up to approximately 1 year 2 months
Dose Escalation Part: Objective Response Rate (ORR)
ORR was defined as the number of participants with a best overall response of complete response (CR) or partial response (PR) based on the Lugano criteria as assessed by investigator. All other categories, including not evaluable, were considered non-response. CR was defined as all of the following: disappearance of all target and non-target tumor lesions, and reduction in short axis to <10 millimeters (mm) in all pathological target and non-target lymph nodes, and normalization of tumor marker level (if applicable). PR was defined as ≥30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Data are presented for the number of participants with ORR.
Measured: Up to approximately 1 year 2 months
Dose Escalation Part: Duration of Response (DOR)
DOR was defined as the time from the first documentation of response (CR or PR) to the date of progressive disease or death, whichever occurred earlier based on the Lugano criteria as assessed by investigator.
Measured: Up to approximately 1 year 2 months
Dose Escalation Part: Time to Response (TTR)
TTR was defined as the time from Day 1 to first documentation of objective response (CR or PR) in participants achieving PR or CR based on the Lugano criteria as assessed by investigator.
Measured: Up to approximately 1 year 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2023
- Study start21 Sep 2023
- Primary completion5 Feb 2025
- Study completion5 Feb 2025
Why it stopped: Genmab discontinued GEN3017 program following a strategic re-evaluation of Genmab's portfolio.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Classical Hodgkin LymphomaStudies of the same condition, open and under way.
- More trials run by GenmabThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genmab
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Official, Study director, Genmab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06018129
- Sponsor's protocol ID
- GCT3017-01
- Other IDs
- 2023-503348-15-00, jRCT2031230576, 2023
- Status last verified
- Sep 2025
- First submitted
- 25 Aug 2023
- Last updated
- 25 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06018129
- Acronym / sponsor ID
- GCT3017-01
- Conditions
- Classical Hodgkin Lymphoma, Non-Hodgkin Lymphoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Genmab discontinued GEN3017 program following a strategic re-evaluation of Genmab's portfolio.
- Enrolment
- 9 participants (actual)
- Lead sponsor
- GenmabIndustry (pharma, biotech, devices)
- Study start
- 21 Sep 2023 (actual)
- Primary completion
- 5 Feb 2025 (actual)
- Study completion
- 5 Feb 2025 (actual)
- First posted
- 30 Aug 2023 (actual)
- Results
- Posted 23 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| R/R CD30+ cHL Cohort | Experimental | Biological: GEN3017 |
| R/R CD30+ TCL Cohort | Experimental | Biological: GEN3017 |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GEN3017Also: DuoBody® CD3xCD30Subcutaneous injection | Biological | R/R CD30+ TCL Cohort, R/R CD30+ cHL Cohort |
Primary outcome
Dose Escalation Part: Number of Participants With Dose-Limiting Toxicities (DLTs)
Time frame: 21 days
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]).
Dose Escalation Part: Number of Participants With Adverse Events (AEs)
Time frame: Up to approximately 1 year 2 months
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.
12 secondary outcomes
Dose Escalation Part: Maximum (Peak) Plasma Concentration (Cmax) of GEN3017
Time frame: Day 1 and Day 8
Dose Escalation Part: Time to Reach Cmax (Tmax) of GEN3017
Time frame: Day 1 and Day 8
Dose Escalation Part: Pre-dose (Trough) Concentration (Ctrough) of GEN3017
Time frame: Day 1 and Day 8
Dose Escalation Part: Area Under the Concentration-time Curve (AUC) From Time Zero to Infinity (AUCinf) of GEN3017
Time frame: 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
Time frame: Day 1 and Day 8
Dose Escalation Part: Elimination Half-life (T1/2) of GEN3017
Time frame: Day 1 and Day 8
Dose Escalation Part: Total Body Clearance (CL) of Drug From Plasma of GEN3017
Time frame: Day 1 and Day 8
Dose Escalation Part: Volume of Distribution (Vd) of GEN3017
Time frame: Day 1 and Day 8
Dose Escalation Part: Number of Participants With Anti-drug Antibodies (ADAs) to GEN3017
Time frame: Up to approximately 1 year 2 months
Dose Escalation Part: Objective Response Rate (ORR)
Time frame: Up to approximately 1 year 2 months
Dose Escalation Part: Duration of Response (DOR)
Time frame: Up to approximately 1 year 2 months
Dose Escalation Part: Time to Response (TTR)
Time frame: Up to approximately 1 year 2 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results Summary in Plain LanguageLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Official study director
Genmab
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing GEN3017 in people with Classical Hodgkin Lymphoma and Non-Hodgkin Lymphoma, run by Genmab at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose Escalation Part: Number of Participants With Dose-Limiting Toxicities (DLTs) (time frame: 21 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2025.