Clinical trial • Phase I/II • Oncology|Rare Disease
EPCORITAMAB for Diffuse large B-cell lymphoma | B-cell Non-Hodgkin lymphoma
Phase I/II trial of EPCORITAMAB for Diffuse large B-cell lymphoma | B-cell Non-Hodgkin lymphoma. open-label, adaptive. 74 participants.
Overview
- Trial Therapeutic Area
- Oncology|Rare Disease
- Trial Disease
- Diffuse large B-cell lymphoma | B-cell Non-Hodgkin lymphoma
- Trial Stage
- Phase I/II
- Drug Modality
- Bispecific antibody|ADC|Monoclonal antibody|Small molecule
- Orphan Drug
- Yes
Key dates
- Initial CTIS Submission Date
- 30-11-2023
- First CTIS Authorization Date
- 05-02-2024
Trial design
open-label, adaptive Phase I/II trial across 40 sites in Spain, Denmark, Czechia and others.
- Open Label
- Yes
- Adaptive
- True, Dose-escalation elements are included: assessment of DLTs to determine the recommended dose for further investigation (phase 1b dose-finding objectives stated).
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 74
Eligibility
Recruits 74 adults.
Inclusion criteria
- {"criterion_text":"- Adult male or female, at least 18 years old"}
- {"criterion_text":"- (Arms 1, 2, 3, and 4) Diagnosis of DLBCL (de novo or histologically transformed from follicular lymphoma or nodal marginal zone lymphoma) with histologically confirmed CD20+ disease, inclusive of the following according to WHO 2016 classification and documented in pathology report: DLBCL, not otherwise specified (NOS) - High-grade B cell lymphoma with MYC and BCL-2 and/or BCL-6 translocations per World Health Organization (WHO) 2016 (\"double-hit\" or \"triple-hit\") Note: High-grade B-cell lymphomas NOS or other double-/triple-hit lymphomas (with histologies not consistent with DLBCL) are not eligible - FL Grade 3B OR FL with histologically confirmed CD20+ Grade 1 to 3a and no evidence of histologic transformation to an aggressive lymphoma at most recent representative tumor biopsy, according to WHO 2016 classification. OR MCL with histologically confirmed CD20+ disease at most recent representative tumor biopsy according to the WHO 2016 classification with evidence of overexpression of cyclin D1 in association with relevant markers or evidence of t(11;14) assessed by flow cytometry, FISH, or PCR"}
- {"criterion_text":"- Subject must have Eastern Cooperative Oncology Group (ECOG) performance status 0 – 2, except for Arms 6, 7 and 8where ECOG performance status must be 0-1"}
- {"criterion_text":"- Subject must have 1 or more measurable disease sites: A positron emission tomography/computed tomography (PET/CT) scan demonstrating PET-positive lesion(s) AND - At least 1 measurable nodal lesion (long axis > 1.5 cm) or ≥ 1 measurable extra-nodal lesion (long axis > 1.0 cm) on CT scan or MRI"}
Exclusion criteria
- {"criterion_text":"- Diagnosis of High-grade B-cell lymphomas NOS or other double- /triple-hit lymphomas (with histologies not consistent with DLBCL)"}
- {"criterion_text":"- Subjects who have had prior treatment with epcoritamab or any other bispecific antibody targeting CD3 and CD20"}
Endpoints
Primary endpoints
- {"endpoint_text":"- The primary endpoint is DLTs of epcoritamab in combination with antineoplastic agents.","definition_or_measurement_approach":""}
Secondary endpoints
- {"endpoint_text":"- Best overall response (BOR) by Lugano 2014 criteria as assessed by investigator for epcoritamab in combination with other antineoplastic agents.","definition_or_measurement_approach":"Assessed by investigator using Lugano 2014 criteria"}
- {"endpoint_text":"- Antilymphoma activity of epcoritamab in combination with other antineoplastic agents: - Duration of response determined per Lugano 2014 criteria as assessed by investigator. - Progression free survival determined per Lugano 2014 criteria as assessed by investigator. - Complete response during the study determined per Lugano 2014 criteria as assessed by investigator. - Time to response determined per Lugano 2014 criteria as assessed by investigator. - Time to next antilymphoma therapy.","definition_or_measurement_approach":"Components determined per Lugano 2014 criteria as assessed by investigator"}
Recruitment
- Digital Remote Recruitment
- True, country-specific website copy, downloadable patient study guides, online brochures and website materials (documents titled 'Website Copy', 'Patient Downloadable Study Guide', 'EPCORE Website Copy', and other K2 recruitment materials) are included.
- Planned Sample Size
- 74
- Recruitment Window Months
- 125
- Consent Approach
- Informed consent is obtained from adult subjects (≥18 years) using country-specific subject information and informed consent forms; multiple country-language ICFs are provided (e.g., ES, NL, CZ, DE, FR, HU, DK). Optional and specific ICFs are available (e.g., Optional ICFs, Pregnant partner ICF, Genetic ICFs, Pregnancy Prevention Plans) and a Power of Attorney form is listed for use where applicable.
Methods
- Spain: Country-specific recruitment materials listed (K1_M22-132 ES Recruitment and ICF Procedures; K2_M22-132 ES EPCORE Website Copy; EPCORE Patient-Doctor Discussion Guide; EPCORE Patient Downloadable Study Guide) — materials indicate website and patient-facing downloadable guides and patient-doctor discussion aids.
- Netherlands: Recruitment materials and brochures listed (K1_M22-132_NL_Recruitment and ICF Procedures; K2_M22-132_NL_Recruitment Material Brochure) — country-specific brochures and website copy.
- Czechia: Recruitment brochure documents listed (K2 M22-132 CZ Recruitment Brochure_Public) indicating use of recruitment brochures.
- Germany: Recruitment and ICF procedures and recruitment brochure/ad materials listed (K1_M22-132_DE_Recruitment and ICF procedures_public; K2_M22-132_DE_Recruitment Brochure_public; ad and caregiver booklet) indicating local brochures/ads and caregiver-targeted materials.
- France, Hungary, Denmark: Country-specific recruitment and ICF procedure documents are present in the document list indicating local recruitment materials and procedures.
Geography
- Total Number Of Sites
- 40
- Total Number Of Participants
- 59
Spain
- Earliest CTIS Part Ii Submission Date
- 15-12-2023
- Latest Decision Or Authorization Date
- 12-11-2025
- Processing Time Days
- 698
- Number Of Sites
- 10
- Number Of Participants
- 29
Sites
- Site Name
- Hospital Universitario 12 De Octubre
- Contact Person Name
- Ana Jimenez Ubieto
- Contact Person Email
- anitiju@hotmail.com
- Site Name
- University Hospital Virgen Del Rocio S.L.
- Contact Person Name
- Guillermo Rodriguez
- Contact Person Email
- grgarcia@gmail.com
- Site Name
- Clinica Universidad De Navarra
- Contact Person Name
- Carlos Grande Garcia
- Contact Person Email
- cgrandeg@unav.es
- Site Name
- Hospital Universitari Vall D Hebron
- Contact Person Name
- Pau Abrisqueta Costa
- Contact Person Email
- pabrisqueta@vhio.net
- Site Name
- Hospital Universitario Fundacion Jimenez Diaz
- Contact Person Name
- Daniel Morillo Giles
- Contact Person Email
- dmorillo@startmadrid.com
- Site Name
- Institut Catala D'oncologia
- Contact Person Name
- Juan Manuel Sancho
- Contact Person Email
- jsancho@iconcologia.net
- Site Name
- Institut Catala D'oncologia
- Contact Person Name
- Anna Sureda Balari
- Contact Person Email
- asureda@iconcologia.net
- Site Name
- Hospital Universitario De Salamanca
- Contact Person Name
- Alejandro Martin Garcia-Sancho
- Contact Person Email
- amartingar@usal.es
- Site Name
- Clinica Universidad De Navarra
- Contact Person Name
- arlos Grande Garcia
- Contact Person Email
- cgrandeg@unav.es
- Site Name
- Hospital Clinico Universitario De Valencia
- Contact Person Name
- Maria Jose Terol Castera
- Contact Person Email
- maria.jose.terol@uv.es
Denmark
- Earliest CTIS Part Ii Submission Date
- 15-12-2023
- Latest Decision Or Authorization Date
- 10-11-2025
- Processing Time Days
- 696
- Number Of Sites
- 2
- Number Of Participants
- 1
Sites
- Site Name
- Region Midtjylland
- Department Name
- Department of Hematology
- Contact Person Name
- Judit Joergensen
- Contact Person Email
- judit.joergensen@aarhus.rm.dk
- Site Name
- Aalborg University Hospital
- Department Name
- Department of Hematology
- Contact Person Name
- Paw Jensen
- Contact Person Email
- paje@rn.dk
Czechia
- Earliest CTIS Part Ii Submission Date
- 15-12-2023
- Latest Decision Or Authorization Date
- 10-11-2025
- Processing Time Days
- 696
- Number Of Sites
- 4
- Number Of Participants
- 5
Sites
- Site Name
- Fakultni Nemocnice Brno
- Contact Person Name
- Jiri Mayer
- Contact Person Email
- mayer.jiri@fnbrno.cz
- Site Name
- Fakultni Nemocnice Hradec Kralove
- Contact Person Name
- David Belada
- Contact Person Email
- david.belada@fnhk.cz
- Site Name
- Fakultni Nemocnice Ostrava
- Contact Person Name
- Roman Hajek
- Contact Person Email
- roman.hajek@fno.cz
- Site Name
- Vseobecna Fakultni Nemocnice V Praze
- Contact Person Name
- Mark Trneny
- Contact Person Email
- trneny@cesnet.cz
Netherlands
- Earliest CTIS Part Ii Submission Date
- 15-12-2023
- Latest Decision Or Authorization Date
- 10-11-2025
- Processing Time Days
- 696
- Number Of Sites
- 4
- Number Of Participants
- 5
Sites
- Site Name
- University Hospital Maastricht
- Contact Person Name
- Marjolein van der Poel
- Contact Person Email
- Research.hematologie@mumc.nl
- Site Name
- Amsterdam UMC
- Contact Person Name
- Martine Chamuleau
- Contact Person Email
- hematology@amsterdamumc.nl
- Site Name
- Academisch Ziekenhuis Leiden
- Contact Person Name
- Joost Vermaat
- Contact Person Email
- j.s.p.vermaat@lumc.nl
- Site Name
- Universitair Medisch Centrum Groningen
- Contact Person Name
- Marcel Nijland
- Contact Person Email
- trialbureauhematologie@onco.umcg.nl
Hungary
- Earliest CTIS Part Ii Submission Date
- 15-12-2023
- Latest Decision Or Authorization Date
- 11-11-2025
- Processing Time Days
- 697
- Number Of Sites
- 4
- Number Of Participants
- 4
Sites
- Site Name
- Orszagos Onkologiai Intezet
- Contact Person Name
- Andras Masszi
- Contact Person Email
- masszi.andras@oncol.hu
- Site Name
- Somogy Varmegyei Kaposi Mor Oktato Korhaz
- Contact Person Name
- Peter Rajnics
- Contact Person Email
- hematologia@kmmk.hu
- Site Name
- Semmelweis University
- Contact Person Name
- Zsolt Nagy
- Contact Person Email
- nagy.zsolt@med.semmelweis-univ.hu
- Site Name
- University Of Debrecen
- Contact Person Name
- Arpad Illes
- Contact Person Email
- illesarpaddr@gmail.com
Germany
- Earliest CTIS Part Ii Submission Date
- 15-12-2023
- Latest Decision Or Authorization Date
- 10-11-2025
- Processing Time Days
- 696
- Number Of Sites
- 6
- Number Of Participants
- 1
Sites
- Site Name
- Universitaetsklinikum Regensburg
- Contact Person Name
- Stephanie Mayer
- Contact Person Email
- Ectu.Ukr@klinik.uni-regensburg.de
- Site Name
- Universitaetsklinikum Wuerzburg AöR
- Contact Person Name
- Johannes Duell
- Contact Person Email
- Duell_J@ukw.de
- Site Name
- Universitaetsklinikum Augsburg
- Contact Person Name
- Boris Kubuschok
- Contact Person Email
- Studien2.med@uk-augsburg.de
- Site Name
- Universitaetsklinikum Ulm AöR
- Contact Person Name
- Andreas Viardot
- Contact Person Email
- ectu.cooperation@uniklinik-ulm.de
- Site Name
- Philipps-Universitaet Marburg
- Contact Person Name
- Joerg Hoffmann
- Contact Person Email
- studien-onkologie@uni-marburg.de
- Site Name
- Universitaet Leipzig
- Contact Person Name
- Carmen Herling
- Contact Person Email
- Haematologie.Studieneinheit@medizin.uni-leipzig.de
France
- Earliest CTIS Part Ii Submission Date
- 15-12-2023
- Latest Decision Or Authorization Date
- 21-11-2025
- Processing Time Days
- 707
- Number Of Sites
- 10
- Number Of Participants
- 14
Sites
- Site Name
- Centre Hospitalier Universitaire De Rennes
- Contact Person Name
- Roch Houot
- Contact Person Email
- roch.houot@chu-rennes.fr
- Site Name
- Hopital Saint Louis
- Contact Person Name
- Catherine Thieblemont
- Contact Person Email
- catherine.thieblemont@sls.aphp.fr
- Site Name
- CHRU De Nancy
- Contact Person Name
- Pierre Feugier
- Contact Person Email
- p.feugier@chu-nancy.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Contact Person Name
- Corinne Haioun
- Contact Person Email
- corinne.haioun@aphp.fr
- Site Name
- University Hospital Of Clermont-Ferrand
- Contact Person Name
- Romain Guieze
- Contact Person Email
- rguieze@chu-clermontferrand.fr
- Site Name
- University Hospitals Pitie Salpetriere Charles Foix
- Contact Person Name
- Sylvain Choquet
- Contact Person Email
- sylvain.choquet@psl.aphp.fr
- Site Name
- Centre Hospitalier Universitaire De Lille
- Contact Person Name
- Franck Morschhauser
- Contact Person Email
- franck.morschhauser@chru-lille.fr
- Site Name
- Institut Universitaire Du Cancer Toulouse-Oncopole
- Contact Person Name
- Lucie Oberic
- Contact Person Email
- oberic.lucie@iuct-oncopole.fr
- Site Name
- Centre Hospitalier Universitaire De Nantes
- Contact Person Name
- Benoit Tessoulin
- Contact Person Email
- benoit.tessoulin@chu-nantes.fr
- Site Name
- Centre Hospitalier Lyon Sud
- Contact Person Name
- Herve Ghesquieres
- Contact Person Email
- herve.ghesquieres@chu-lyon.fr
Sponsor
Primary sponsor
- Full Name
- AbbVie Deutschland GmbH & Co. KG
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Germany
Contract research organisations
- Name
- Clinical Trial Media Inc.
- Responsibilities
- Global recruitment vendor
- Name
- Medidata Solutions Inc.
- Responsibilities
- ePRO and EDC
- Name
- Perceptive Informatics Inc.
- Responsibilities
- Medical Imaging and IRC
- Name
- Cerba Research
- Name
- Labcorp
- Name
- Q Squared Solutions Limited
- Name
- Labcorp Central Laboratory Services S.a.r.l.
Third parties
- {"country":"United States","full_name":"Clinical Trial Media Inc.","duties_or_roles":"Global recruitment vendor","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Medical Equipment Supplies And Management Limited","duties_or_roles":"Thermometer supply","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"ePRO and EDC","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services S.a.r.l.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Q Squared Solutions Limited","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Belgium","full_name":"Cerba Research","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Perceptive Informatics Inc.","duties_or_roles":"Medical Imaging and IRC","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Labcorp","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
Investigational products
- Investigational Product Name
- Epcoritamab (GEN3013)
- Active Substance
- EPCORITAMAB
- Modality
- Bispecific antibody
- Routes Of Administration
- Subcutaneous injection
- Route
- Subcutaneous
- Authorisation Status
- 1
- Orphan Designation
- Yes
- Investigational Product Name
- Polivy 30 mg powder for concentrate for solution for infusion.
- Active Substance
- POLATUZUMAB VEDOTIN
- Modality
- ADC
- Routes Of Administration
- Intravenous
- Route
- Intravenous
- Authorisation Status
- 2
- Investigational Product Name
- Truxima 100 mg concentrate for solution for infusion
- Active Substance
- RITUXIMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- Intravenous
- Route
- Intravenous
- Authorisation Status
- 2
- Investigational Product Name
- IMBRUVICA 140 mg hard capsules
- Active Substance
- IBRUTINIB
- Modality
- Small molecule
- Routes Of Administration
- Oral
- Route
- Oral
- Authorisation Status
- 2
- Investigational Product Name
- Golcadomide
- Active Substance
- GOLCADOMIDE
- Modality
- Small molecule
- Routes Of Administration
- Oral
- Route
- Oral
- Authorisation Status
- 1
- Investigational Product Name
- Revlimid (lenalidomide) hard capsules (various strengths)
- Active Substance
- LENALIDOMIDE
- Modality
- Small molecule
- Routes Of Administration
- Oral
- Route
- Oral
- Authorisation Status
- 2
- Investigational Product Name
- PIRTOBRUTINIB
- Active Substance
- PIRTOBRUTINIB
- Modality
- Small molecule
- Routes Of Administration
- Oral
- Route
- Oral
- Authorisation Status
- 2
- Investigational Product Name
- Cyclophosphamide Injection 500 mg.
- Active Substance
- CYCLOPHOSPHAMIDE
- Modality
- Small molecule
- Routes Of Administration
- Intravenous
- Route
- Intravenous
- Authorisation Status
- 2
- Investigational Product Name
- Venetoclax (ABT-199)
- Active Substance
- VENETOCLAX
- Modality
- Small molecule
- Routes Of Administration
- Oral
- Route
- Oral
- Authorisation Status
- 1
- Investigational Product Name
- Decortin® H (Prednisolone) tablets
- Active Substance
- PREDNISOLONE
- Modality
- Small molecule (steroid)
- Routes Of Administration
- Oral
- Route
- Oral
- Authorisation Status
- 2
- Investigational Product Name
- Adriblastin® (Doxorubicin hydrochloride) 50 mg
- Active Substance
- DOXORUBICIN HYDROCHLORIDE
- Modality
- Small molecule (cytotoxic chemotherapy)
- Routes Of Administration
- Intravenous
- Route
- Intravenous
- Authorisation Status
- 2
- Combination Treatment
- Yes
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