Clinical trial • Phase I/II • Oncology
EPCORITAMAB for B-cell lymphoma | Non-Hodgkin B-cell lymphoma
Phase I/II trial of EPCORITAMAB for B-cell lymphoma | Non-Hodgkin B-cell lymphoma. open-label, adaptive. 312 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- B-cell lymphoma | Non-Hodgkin B-cell lymphoma
- Trial Stage
- Phase I/II
- Drug Modality
- Bispecific antibody
- Orphan Drug
- Yes
Key dates
- Initial CTIS Submission Date
- 08-01-2024
- First CTIS Authorization Date
- 07-02-2024
Trial design
open-label, adaptive Phase I/II trial in Italy, France, Finland and others.
- Open Label
- Yes
- Adaptive
- True, design includes dose-escalation to determine MTD and RP2D, expansion cohorts for efficacy assessment, and an optimization part to evaluate alternative priming/intermediate dose regimens intended to reduce CRS risk; includes planned PK, interim safety assessments and dose-limiting toxicity evaluations.
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 312
Eligibility
Recruits 312 Vulnerable population selected in the CTIS record. Only adults are eligible (minimum age 18 years; for expansion in some countries legal age 21 is required). Informed consent is required; multiple subject information and informed consent form (L1_SIS and ICF) documents are listed (country/language-specific versions, including documents titled 'Pregnant Partner' and 'Waiver for Knowledge'). No assent process for minors is described in the available trial data..
- Vulnerable Population
- Vulnerable population selected in the CTIS record. Only adults are eligible (minimum age 18 years; for expansion in some countries legal age 21 is required). Informed consent is required; multiple subject information and informed consent form (L1_SIS and ICF) documents are listed (country/language-specific versions, including documents titled 'Pregnant Partner' and 'Waiver for Knowledge'). No assent process for minors is described in the available trial data.
Inclusion criteria
- {"criterion_text":"- 1. Patient must be 18 years of age or older (for expansion: In countries where the legal age is 21 years of age; only patients 21 years of age or older are eligible)\n- 2. Documented CD20+ mature non-Hodgkin B-cell lymphoma according to WHO classification\n- 3. Relapsed, progressive and/or refractory disease (Cheson et al., 2007) following treatment with an anti-CD20 monoclonal antibody\n- 4. Patients must have received at least 2 prior lines of therapy\n- 5. Patients must have measurable disease by imaging\n- 6. Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2. For MCL: ECOG PS <2 required for participation.\n- 7. For the optimization part, patients must have R/R DLBCL, or FL grades 1-3A, or MCL (according to cohort)."}
Exclusion criteria
- {"criterion_text":"- 1. Primary central nervous system (CNS) lymphoma or known CNS involvement by lymphoma\n- 2. AST, and/or ALT > 3 x upper limit of normal\n- 3. Total bilirubin > 1.5 x upper limit of normal\n- 4. Creatinine clearance < 45 mL/min\n- 5. Known clinically significant cardiac disease, including: a. Onset of unstable angina pectoris within 6 months of signing ICF b. Acute myocardial infarction within 6 months of signing ICF c. Congestive heart failure (grade III or IV as classified by the New York Heart Association and/or known decrease ejection fraction of < 45%\n- 6. Ongoing active bacterial, viral, fungal, mycobacterial, parasitic, or other infection requiring systemic treatment (excluding prophylactic treatment) at the time of enrolment or within the previous 2 weeks prior to the first dose of epcoritamab, including COVID-19 infection.\n- 7. Eligible for curative salvage therapy with high dose therapy followed by stem cell rescue\n- 8. Active hepatitis B (DNA PCR-positive) or hepatitis C (RNA PCR positive infection). Subjects with evidence of prior HBV but who are PCRnegative are permitted in the trial but should receive prophylactic antiviral therapy.\n- 9. Known human immunodeficiency virus (HIV) infection.\n- 10. Exposed to live or live attenuated vaccine within 4 weeks prior to signing ICF\n- 11. Prior treatment with chimeric antigen receptor T-cell (CAR-T) therapy within 30 days prior to first GEN3013 administration\n- 12. Autologous HSCT within 100 days prior to first GEN3013 administration, or any prior allogeneic HSCT or solid organ transplantation\n- 13. Contraindication to all uric acid lowering agents"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Escalation End Points: - Dose limiting toxicity - Adverse events\n- Expansion End Points: - Overall response rate (ORR) determined by Lugano criteria as assessed by independent review committee (IRC)\n- Optimization End Points: - Adverse events; Rating of ≥ Grade 2 CRS events","definition_or_measurement_approach":"Escalation: DLT and adverse events (safety reporting). Expansion: ORR determined by Lugano criteria assessed by an independent review committee (IRC). Optimization: adverse events with specific assessment of Grade ≥2 CRS events (CRS grading as per protocol)."}
Secondary endpoints
- {"endpoint_text":"- Escalation End Points: - Cytokine measures - Laboratory parameters (biochemistry, hematology including immunophenotyping for absolute T-cell and B-cell counts as well as Tcell activation and exhaustion markers) - PK parameters (clearance, volume of distribution and area-under-the concentration- time curve (AUC0-Clast and AUC0-∞), maximum concentration (Cmax), time of Cmax (Tmax), pre dose values, and halflife)\n- Escalation End Points: - Immunogenicity of GEN3013 - Anti-lymphoma activity, i.e. resolution of constitutional symptoms, reduction in tumor size, objective and best response - Duration of response - Progression free survival - Time to next anti-lymphoma therapy - Overall survival\n- Expansion/Optimization: - Duration of response (DOR) determined by Lugano criteria - Complete response (CR) rate determined by Lugano criteria - Duration of CR (DoCR) by Lugano criteria - Progression-free survival (PFS) determined by Lugano criteria - Time to response (TTR) determined by Lugano criteria\n- Expansion/Optimization: - Objective and best response rate determined by LYRIC; PFS, DOR, DoCR, TTR, OS determined by LYRIC\n- Expansion/Optimization: - Time to next (anti-lymphoma) therapy (TTNT) - Rate of MRD negativity - Safety (adverse events, laboratory parameters, hospitalizations, and cytokine measures)\n- Expansion/Optimization: - PK parameters and incidence of ADAs to GEN3013 - Changes in lymphoma symptoms measured by FACT-Lym\n- Expansion/Optimization: - Rate of ≥ Grade 2 CRS events and all grade CRS events following first full dose and overall","definition_or_measurement_approach":"Includes cytokine assays, laboratory tests, PK parameter calculations (AUC, Cmax, Tmax, clearance, half-life), immunogenicity assays (ADA), efficacy assessments by Lugano and LYRIC criteria (by IRC and investigator), MRD assessment, survival endpoints (DOR, PFS, OS), PROs via FACT-Lym, and CRS grading (≥ Grade 2 events) as specified in protocol."}
Recruitment
- Planned Sample Size
- 312
- Recruitment Window Months
- 120
- Consent Approach
- Informed consent obtained from adult participants. Age eligibility: ≥18 years (expansion cohorts in some countries require ≥21 years). Multiple country- and language-specific subject information and informed consent form documents are listed (L1_SIS and ICF files in EN, IT, FR, FI, DE, NL, PL, SE etc.). Additional ICF material referenced includes 'Pregnant Partner' information and a 'Waiver for Knowledge' document in some jurisdictions. No assent process for minors is described in available documents.
Geography
- Total Number Of Sites
- 41
- Total Number Of Participants
- 395
Italy
- Earliest CTIS Part Ii Submission Date
- 22-01-2024
- Latest Decision Or Authorization Date
- 24-02-2026
- Processing Time Days
- 764
- Number Of Sites
- 5
- Number Of Participants
- 42
Sites
- Site Name
- Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
- Department Name
- Onco-hematology
- Contact Person Name
- Pierluigi Zinzani
- Contact Person Email
- pierluigi.zinzani@unibo.it
- Site Name
- Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS
- Department Name
- Onco-hematology
- Contact Person Name
- Umberto Vitolo
- Contact Person Email
- umberto.vitolo@ircc.it
- Site Name
- Ospedale San Raffaele S.r.l.
- Department Name
- Onco-Hematology - Lymphoma Unit
- Contact Person Name
- Andrés José Maria Ferreri
- Contact Person Email
- ferreri.andres@hsr.it
- Site Name
- Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
- Department Name
- Hematology
- Contact Person Name
- Gerardo Musuraca
- Contact Person Email
- gerardo.musuraca@irst.emr.it
- Site Name
- Azienda Ospedaliera Nazionale Ss Antonio E Biagio E C Arrigo Alessandria
- Department Name
- Hematology
- Contact Person Name
- Manuela Zanni
- Contact Person Email
- manuela.zanni@ospedale.al.it
France
- Earliest CTIS Part Ii Submission Date
- 22-01-2024
- Latest Decision Or Authorization Date
- 23-02-2026
- Processing Time Days
- 763
- Number Of Sites
- 5
- Number Of Participants
- 61
Sites
- Site Name
- Assistance Publique Hopitaux De Paris (Creteil Cedex)
- Department Name
- Unite Hemopathies Lymphoïdes
- Contact Person Name
- Corinne HAIOUN
- Contact Person Email
- corinne.haioun@aphp.fr
- Site Name
- Assistance Publique Hopitaux De Paris (Paris Cedex 10)
- Department Name
- Service Hematologie-Oncologie
- Contact Person Name
- Catherine THIEBLEMONT
- Contact Person Email
- catherine.thieblemont@aphp.fr
- Site Name
- Centre Hospitalier Regional Universitaire De Tours
- Department Name
- Centre Henri S. Kaplan / Hematologie et Therapie Cellulaire
- Contact Person Name
- Emmanuel GYAN
- Contact Person Email
- emmanuel.gyan@univ-tours.fr
- Site Name
- Hospices Civils De Lyon
- Department Name
- Service d’Hematologie Clinique
- Contact Person Name
- Herve GHESQUIERES
- Contact Person Email
- herve.ghesquieres@chu-lyon.fr
- Site Name
- Centre Henri Becquerel
- Department Name
- Service Hematologie
- Contact Person Name
- Herve TILLY
- Contact Person Email
- herve.tilly@chb.unicancer.fr
Finland
- Earliest CTIS Part Ii Submission Date
- 22-01-2024
- Latest Decision Or Authorization Date
- 24-02-2026
- Processing Time Days
- 764
- Number Of Sites
- 3
- Number Of Participants
- 10
Sites
- Site Name
- HUS-Yhtymae
- Department Name
- Department of Oncology
- Contact Person Name
- Sirpa Leppa
- Contact Person Email
- sirpa.leppa@hus.fi
- Site Name
- Tampere University Hospital
- Department Name
- Department of Oncology
- Contact Person Name
- Marjukka Pollari
- Contact Person Email
- marjukka.pollari@pirha.fi
- Site Name
- Kuopio University Hospital
- Department Name
- Department of Oncology
- Contact Person Name
- Outi Kuittinen
- Contact Person Email
- outi.kuittinen@kuh.fi
Netherlands
- Earliest CTIS Part Ii Submission Date
- 22-01-2024
- Latest Decision Or Authorization Date
- 24-02-2026
- Processing Time Days
- 764
- Number Of Sites
- 4
- Number Of Participants
- 68
Sites
- Site Name
- University Hospital Maastricht
- Department Name
- Hematology
- Contact Person Name
- Marjolein van der Poel
- Contact Person Email
- marjolein.vander.poel@mumc.nl
- Site Name
- Universitair Medisch Centrum Utrecht
- Department Name
- Hematology
- Contact Person Name
- Rimke Oostvogels
- Contact Person Email
- r.oostvogels@umcutrecht.nl
- Site Name
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Department Name
- Hematology
- Contact Person Name
- Pieternella Lugtenburg
- Contact Person Email
- p.lugtenburg@erasmusmc.nl
- Site Name
- Amsterdam UMC
- Department Name
- Hematology
- Contact Person Name
- Martine Chamuleau
- Contact Person Email
- m.chamuleau@vumc.nl
Denmark
- Earliest CTIS Part Ii Submission Date
- 22-01-2024
- Latest Decision Or Authorization Date
- 23-02-2026
- Processing Time Days
- 763
- Number Of Sites
- 3
- Number Of Participants
- 59
Sites
- Site Name
- Lillebaelt Hospital
- Department Name
- Department of Hematology
- Contact Person Name
- Michael Roost Clausen
- Contact Person Email
- michael.roost.clausen@rsyd.dk
- Site Name
- Odense University Hospital
- Department Name
- Haematological Research Unit
- Contact Person Name
- Jacob Haaber
- Contact Person Email
- jacob.h.christensen@rsyd.dk
- Site Name
- Rigshospitalet
- Department Name
- Department of Hematology
- Contact Person Name
- Martin Hutchings
- Contact Person Email
- Martin.Hutchings@regionh.dk
Sweden
- Earliest CTIS Part Ii Submission Date
- 22-01-2024
- Latest Decision Or Authorization Date
- 24-02-2026
- Processing Time Days
- 764
- Number Of Sites
- 3
- Number Of Participants
- 22
Sites
- Site Name
- Region Skane Skanes Universitetssjukhus
- Department Name
- Hematology/Oncology/Radiology
- Contact Person Name
- Mats Jerkeman
- Contact Person Email
- mats.jerkeman@med.lu.se
- Site Name
- Karolinska University Hospital
- Department Name
- Hematology Clinic
- Contact Person Name
- Kristina Sonnevi
- Contact Person Email
- kristina.sonnevi@regionstockholm.se
- Site Name
- Uppsala University Hospital
- Department Name
- Hematology/Oncology Clinic
- Contact Person Name
- Ingrid Glimelius
- Contact Person Email
- ingrid.glimelius@igp.uu.se
Germany
- Earliest CTIS Part Ii Submission Date
- 22-01-2024
- Latest Decision Or Authorization Date
- 25-02-2026
- Processing Time Days
- 765
- Number Of Sites
- 6
- Number Of Participants
- 16
Sites
- Site Name
- University Hospital Cologne AöR
- Department Name
- Studienzentrum der Klinik I für Innere Medizin (CTU Cologne)Universitätsklinikum Köln AöR
- Contact Person Name
- Jan-Michel Heger
- Contact Person Email
- jan-michel.heger@uk-koeln.de
- Site Name
- Universitaetsklinikum Essen AöR
- Department Name
- Klinik für Hämatologie und Stammzelltransplantation
- Contact Person Name
- Bastian von Tresckow
- Contact Person Email
- bastian.vontreskow@uk-essen.de
- Site Name
- Klinikum der Universitaet Muenchen AöR
- Department Name
- Medizinische Klinik und Poliklinik III
- Contact Person Name
- Martin Heinz Dreyling
- Contact Person Email
- Martin.Dreyling@med.uni-muenchen.de
- Site Name
- Charite Universitaetsmedizin Berlin KöR
- Department Name
- Medizinische Klinik mit Schwerpunkt Hämatologie, Onkologie und Tumorimmunologie (CBF)
- Contact Person Name
- Corinna Leng
- Contact Person Email
- corinna.leng@charite.de
- Site Name
- Vivantes Netzwerk fuer Gesundheit GmbH
- Department Name
- Haematologie und Onkologie
- Contact Person Name
- Christian Scholz
- Contact Person Email
- christian.scholz@vivantes.de
- Site Name
- Johannes Gutenberg University Mainz
- Department Name
- III Med. Hämatologie/Onkologie
- Contact Person Name
- Georg Hess
- Contact Person Email
- georg.hess@unimedizin-mainz.de
Poland
- Earliest CTIS Part Ii Submission Date
- 22-01-2024
- Latest Decision Or Authorization Date
- 26-02-2026
- Processing Time Days
- 766
- Number Of Sites
- 7
- Number Of Participants
- 60
Sites
- Site Name
- Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
- Department Name
- Klinika Hematologii, Nowotworów Krwi i Transplantacji Szpiku
- Contact Person Name
- Tomasz Wróbel
- Contact Person Email
- twrobel@usk.wroc.pl
- Site Name
- Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
- Department Name
- Klinika Nowotworów Układu Chłonnego
- Contact Person Name
- Joanna Romejko-Jarosińska
- Contact Person Email
- joanna.romejko-jarosinska@pib-nio.pl
- Site Name
- Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy
- Department Name
- Klinika Hematologii
- Contact Person Name
- Jarosław Czyż
- Contact Person Email
- hematologia.sekretariat@biziel.pl
- Site Name
- SZPITAL NA KLINACH Grupa Neo Hospital
- Contact Person Name
- Wojciech Jurczak
- Contact Person Email
- wojciech.jurczak@pratia.com
- Site Name
- Uniwersyteckie Centrum Kliniczne
- Department Name
- Ośrodek Badań Klinicznych Wczesnych Faz
- Contact Person Name
- Jan Zaucha
- Contact Person Email
- jzaucha@gumed.edu.pl
- Site Name
- Pratia S.A.
- Department Name
- Pratia MCM Krakow
- Contact Person Name
- Wojciech Jurczak
- Contact Person Email
- wojciech.jurczak@pratia.com
- Site Name
- Wojewodzki Szpital Specjalistyczny Im. Janusza Korczaka W Slupsku Sp. z o.o.
- Department Name
- Oddział Hematologiczny/Transplantacji Szpiku
- Contact Person Name
- Wojciech Homenda
- Contact Person Email
- wojhom@sl.home.pl
Spain
- Earliest CTIS Part Ii Submission Date
- 22-01-2024
- Latest Decision Or Authorization Date
- 25-02-2026
- Processing Time Days
- 765
- Number Of Sites
- 5
- Number Of Participants
- 57
Sites
- Site Name
- Hospital Universitario Fundacion Jimenez Diaz
- Department Name
- Hematology
- Contact Person Name
- Daniel Morillo Gile
- Contact Person Email
- dmorillo@startmadrid.com
- Site Name
- Clinica Universidad De Navarra
- Department Name
- Hematology
- Contact Person Name
- Miguel Angel Canales
- Contact Person Email
- macanales@unav.es
- Site Name
- Institut Catala D'oncologia
- Department Name
- Hematology
- Contact Person Name
- Ana Maria Sureda Balari
- Contact Person Email
- asureda@iconcologia.net
- Site Name
- Hospital Germans Trias I Pujol
- Department Name
- Hematology
- Contact Person Name
- Juan Manuel Sancho
- Contact Person Email
- jsancho@iconcologia.net
- Site Name
- Fir Huvh Fundacio Institut De Recerca Hospital Universitari Vall De Hebron
- Department Name
- Hematology
- Contact Person Name
- Pau Abrisqueta
- Contact Person Email
- pabrisqueta@vhebron.net
Sponsor
Primary sponsor
- Full Name
- Genmab A/S
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Denmark
Contract research organisations
- Name
- Icon (Lr) Limited
- Responsibilities
- data entry
- Name
- Clinipace Inc.
- Responsibilities
- Programming and statistics; additional responsibilities (codes 6 and 7)
- Name
- Syneos Health Netherlands B.V.
- Responsibilities
- Multiple operational sponsor duties (management/operational roles listed under several duty codes)
- Name
- Covance Caps Limited
- Responsibilities
- Management of safety database and AE reporting
Third parties
- {"country":"Ireland","full_name":"Icon (Lr) Limited","duties_or_roles":"data entry","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Canada","full_name":"Cellcarta Biosciences Inc.","duties_or_roles":"handling biomarker analysis and biomarker testing","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Roche Molecular Systems Inc.","duties_or_roles":"Biomarker analysis and DNA sequencing","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Q Squared Solutions Limited","duties_or_roles":"(duty code 4) (specific duty text not provided)","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Belgium","full_name":"International Drug Development Institute","duties_or_roles":"duties codes 6 and 7 (specific duty text not provided)","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Clinipace Inc.","duties_or_roles":"Programming and statistics; duties codes 6 and 7 (additional duties listed)","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"Expansion ePRO/eCOA, Escalation central ECG","organisation_type":"Pharmaceutical company"}
- {"country":"Netherlands","full_name":"Pharma Bio-Research Group","duties_or_roles":"Handling of bionanalysis","organisation_type":"Pharmaceutical company"}
- {"country":"France","full_name":"Pixilib","duties_or_roles":"Calculation of Total Metabolic Tumor Volume - TMTV","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Covance Caps Limited","duties_or_roles":"Managment of safety database and AE reporting","organisation_type":"Pharmaceutical company"}
- {"country":"Netherlands","full_name":"Syneos Health Netherlands B.V.","duties_or_roles":"Multiple sponsor duties (codes 1,2,5,8,11,12) – roles include project management and operational trial activities (specific text not provided)","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Adaptive Biotechnologies Corp.","duties_or_roles":"handling biomarker analysis and biomarker testing","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Perceptive Informatics Inc.","duties_or_roles":"duty code 13 (specific duty text not provided)","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- Epcoritamab
- Active Substance
- EPCORITAMAB
- Modality
- Bispecific antibody
- Routes Of Administration
- Subcutaneous use
- Route
- Subcutaneous
- Authorisation Status
- Authorised
- Orphan Designation
- Yes
Related trials
Other published trials that may interest you.
- GDC-9545 for Locally advanced or metastatic estrogen receptor-positive breast cancer
- Abemaciclib for Stage IV lung cancer | Breast cancer
- BGB-43395 for Advanced or metastatic solid tumors | Hormone receptor positive HER2 negative breast cancer
- AZD9833 for Estrogen receptor-positive HER2-negative advanced breast cancer
- Pembrolizumab for Classical Hodgkin lymphoma | Melanoma | Solid tumours (MSI-H/dMMR) | Solid tumours (TMB-H)