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Trial Title:
A First-in-human Trial of GEN3017 in Hodgkin Lymphoma and Non-Hodgkin Lymphoma
NCT ID:
NCT06018129
Condition:
Classical Hodgkin Lymphoma
Non-Hodgkin Lymphoma
Conditions: Official terms:
Lymphoma
Lymphoma, Non-Hodgkin
Hodgkin Disease
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
GEN3017
Description:
Subcutaneous injection
Arm group label:
R/R CD30+ TCL Cohort
Arm group label:
R/R CD30+ cHL Cohort
Other name:
DuoBody® CD3xCD30
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.
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).
Criteria for eligibility:
Criteria:
Key Inclusion Criteria:
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.
Key Exclusion Criteria:
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.
Gender:
All
Minimum age:
16 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
City of Hope
Address:
City:
Duarte
Zip:
91010
Country:
United States
Status:
Recruiting
Facility:
Name:
Dana-Farber Cancer Institute
Address:
City:
Boston
Zip:
02215
Country:
United States
Status:
Recruiting
Facility:
Name:
Washington University
Address:
City:
Saint Louis
Zip:
63110
Country:
United States
Status:
Recruiting
Facility:
Name:
Ohio State University
Address:
City:
Columbus
Zip:
43210
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Texas M. D. Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Facility:
Name:
Peter MacCallum Cancer Institute trading as Peter MacCallum Cancer Centre
Address:
City:
Melbourne
Country:
Australia
Status:
Recruiting
Start date:
September 21, 2023
Completion date:
December 31, 2032
Lead sponsor:
Agency:
Genmab
Agency class:
Industry
Source:
Genmab
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06018129
