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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03625037




Registration number
NCT03625037
Ethics application status
Date submitted
7/06/2018
Date registered
10/08/2018
Date last updated
15/02/2021

Titles & IDs
Public title
GEN3013 Trial in Patients With Relapsed, Progressive or Refractory B-Cell Lymphoma
Scientific title
A Phase 1/2, Open-Label Safety Trial of GEN3013 in Patients With Relapsed, Progressive or Refractory B-Cell Lymphoma
Secondary ID [1] 0 0
GCT3013-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diffuse Large B-cell Lymphoma 0 0
High-grade B-cell Lymphoma 0 0
Primary Mediastinal Large B-cell Lymphoma 0 0
Follicular Lymphoma 0 0
Mantle Cell Lymphoma 0 0
Small Lymphocytic Lymphoma 0 0
Marginal Zone Lymphoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Epcoritamab

Experimental: Epcoritamab (GEN3013, DuoBody®-CD3xCD20) - Open label, single arm trial where Epcoritamab will be administered.


Other interventions: Epcoritamab
Epcoritamab will be administered in cycles of 4 weeks i.e. 28 days.

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Escalation: Adverse Events (safety) to determine the Recommended Phase 2 Dose RP2D - -Number of Adverse Events, treatment emergent AEs as assessed by CTCAE V5.0.
Timepoint [1] 0 0
Adverse Events are assessed during the first cycle (28 days) in each cohort.
Primary outcome [2] 0 0
Escalation: Tolerability to determine the RP2D. - -Number of Dose limiting toxicities DLTs.
Timepoint [2] 0 0
DLTs are assessed during the first cycle (28 days) in each cohort.
Primary outcome [3] 0 0
Expansion: Safety, Adverse Event AE Evaluation. - -Total number of AEs and number of treatment emergent AEs as assessed by CTCAE V5.0.
Timepoint [3] 0 0
Until 1 year after last patient enters the trial, through study completion.
Primary outcome [4] 0 0
Expansion: Clinical Efficacy Evaluation. - -Antitumor activity as measured by the objective response rate according to Lugano classification
Timepoint [4] 0 0
Until 1 year after last patient enters the trial, through study completion.
Secondary outcome [1] 0 0
Escalation and Expansion: Pharmacokinetic parameters Cmax - -PK, peak plasma concentration through concentration and half life.
Timepoint [1] 0 0
Until 1 year after last patient enters the trial, through study completion.
Secondary outcome [2] 0 0
Escalation and Expansion: Pharmacokinetic parameters AUC - -Maximum concentration AUC 0-Clast, AUC 0-x and half life.
Timepoint [2] 0 0
During the first 4 doses in each patient
Secondary outcome [3] 0 0
Escalation and Expansion: Immunogenicity-Anti Drug Antibody. - -ADA titers measured as positive or negative host immune response and compared to PK, safety and tumor response.
Timepoint [3] 0 0
Until 1 year after last patient enters the trial, through study completion.
Secondary outcome [4] 0 0
Expansion: Evaluate Patient Reported Outcomes EQ-5D-3L. - -EQ-5D-3L; a six item questionnaire measuring changes from baseline; item 1 addressing a summary of the 5 next being; mobility, self care, usual activity, pain/discomfort, anxiety depression. Measured on a scale from 0 to 100, 100 being best.
Timepoint [4] 0 0
Until 1 year after last patient enters the trial, through study completion.
Secondary outcome [5] 0 0
Expansion: Evaluate Patient Reported Outcomes FACT-Lym. - -FACT-Lym is a 2 module quality of life questionnaire measuring changes from baseline. FACT-G for quality of life and Lym a lymphoma specific questionnaire both using by a 5 point scale 0-4, 4 being best.
Timepoint [5] 0 0
Until 1 year after last patient enters the trial, through study completion.

Eligibility
Key inclusion criteria
Main Inclusion Criteria Escalation Part

- Documented CD20+ mature B-cell neoplasm

1. Diffuse large B-cell lymphoma - de novo or transformed

2. High-grade B-cell lymphoma

3. Primary mediastinal large B-cell lymphoma

4. Follicular lymphoma

5. Mantle cell lymphoma

6. Small lymphocytic lymphoma

7. Marginal zone lymphoma (nodal, extranodal or mucosa associated)

- Relapsed, progressive and/or refractory disease following treatment with an anti-CD20
monoclonal antibody (e.g. rituximab) potentially in combination with chemotherapy
and/or relapsed after autologous stem cell rescue.

- ECOG performance status 0,1 or 2

- Patients must have measurable disease by CT, MRI or PET-CT scan

- Acceptable renal function

- Acceptable liver function

Main Inclusion Criteria Expansion Part

- Documented CD20 positive mature B cell neoplasm or CD20+ MCL

- Diffuse large B cell lymphoma, de novo or transformed (including double hit or triple
hit)

- Primary mediastinal large B cell lymphoma

- Follicular lymphoma grade 3B

- Histologic confirmed follicular lymphoma

- Marginal zone lymphomas

- Small lymphocytic lymphoma

- Mantle Cell Lymphoma (prior BTKi or intolerant to BTKi)

- At least 2 therapies including an anti CD20 monoclonal antibody containing
chemotherapy combination regimen

- Either failed prior autologous hematopoietic stem cell transplantation or ineligible
for autologous stem cell transplantation due to age or comorbidities

- At least 1 measurable site of disease based on CT, MRI or PET-CT scan with involvement
of 2 or more clearly demarcated lesions and or nodes
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1/Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Monash Health - Clayton
Recruitment hospital [2] 0 0
Concord Hospital - Concord
Recruitment hospital [3] 0 0
St. Vincent Hospital - Fitzroy
Recruitment hospital [4] 0 0
Integrated Clinical Oncology Network Pty Ltd (ICON) - Herston
Recruitment hospital [5] 0 0
Royal Hobart Hospital RHH - Hobart
Recruitment hospital [6] 0 0
St. George Hospital - Kogarah
Recruitment hospital [7] 0 0
Cabrini Hospital - Malvern
Recruitment hospital [8] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [9] 0 0
Gold Coast Hospital - Southport
Recruitment hospital [10] 0 0
St George Hospital - Sydney
Recruitment postcode(s) [1] 0 0
- Clayton
Recruitment postcode(s) [2] 0 0
- Concord
Recruitment postcode(s) [3] 0 0
- Fitzroy
Recruitment postcode(s) [4] 0 0
- Herston
Recruitment postcode(s) [5] 0 0
- Hobart
Recruitment postcode(s) [6] 0 0
- Kogarah
Recruitment postcode(s) [7] 0 0
- Malvern
Recruitment postcode(s) [8] 0 0
- Nedlands
Recruitment postcode(s) [9] 0 0
- Southport
Recruitment postcode(s) [10] 0 0
- Sydney
Recruitment outside Australia
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United States of America
State/province [1] 0 0
Arizona
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State/province [2] 0 0
California
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United States of America
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Colorado
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United States of America
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Florida
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United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Iowa
Country [7] 0 0
United States of America
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Louisiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Michigan
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United States of America
State/province [9] 0 0
Nebraska
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State/province [10] 0 0
New Jersey
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North Carolina
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Ohio
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Oregon
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Pennsylvania
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Rhode Island
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United States of America
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South Carolina
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United States of America
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Texas
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United States of America
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Wisconsin
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Canada
State/province [19] 0 0
Calgary
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Canada
State/province [20] 0 0
Toronto
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Denmark
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Copenhagen
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Denmark
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Odense
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Denmark
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Vejle
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Finland
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Helsinki
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Finland
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Kuopio
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Finland
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Tampere
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France
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Créteil
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Lille
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France
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Paris
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France
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Pierre-Bénite
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France
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Rouen cedex
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Tours
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Villejuif
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Cologne
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Essen
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Mainz
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München
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Alessandria
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Bologna
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Italy
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Candiolo
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Italy
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Meldola
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Italy
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Milan
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Korea, Republic of
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Busan
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Daegu
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Goyang-si
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Korea, Republic of
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Jeonju
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Korea, Republic of
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Seongnam-si
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Korea, Republic of
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Seoul
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Netherlands
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Amsterdam
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Maastricht
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Rotterdam
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Netherlands
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Utrecht
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Poland
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Bydgoszcz
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Gdansk
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Kraków
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Lublin
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Slupsk
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Warszawa
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Wroclaw
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Singapore
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Singapore
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Navarra
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Badalona
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Barcelona
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Madrid
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Lund
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Stockholm
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Sweden
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Uppsala
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United Kingdom
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Cardiff
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United Kingdom
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Manchester
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United Kingdom
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Plymouth
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United Kingdom
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Southampton
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United Kingdom
State/province [74] 0 0
Sutton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Genmab
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
AbbVie
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The trial is an open-label, multi-center safety trial of epcoritamab GEN3013
(DuoBody®-CD3xCD20). The trial consists of two parts: a dose escalation part phase 1,
first-in-human (FIH) and an expansion part phase 2a.
Trial website
https://clinicaltrials.gov/show/NCT03625037
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pieternella Lugtenburg, MD, PhD
Address 0 0
Erasmus MC University Medical Center Rotterdam
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Genmab A/S Trial Information
Address 0 0
Country 0 0
Phone 0 0
+45 70202728
Fax 0 0
Email 0 0
clinicaltrials@genmab.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03625037