Clinical trial • Phase I/II • Oncology
EPCORITAMAB for B-cell non-Hodgkin lymphoma | Diffuse large B-cell lymphoma | Follicular lymphoma
Phase I/II trial of EPCORITAMAB for B-cell non-Hodgkin lymphoma | Diffuse large B-cell lymphoma | Follicular lymphoma. open-label, adaptive.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- B-cell non-Hodgkin lymphoma | Diffuse large B-cell lymphoma | Follicular lymphoma
- Trial Stage
- Phase I/II
- Drug Modality
- Bispecific antibody | Monoclonal antibody | Small molecule | Peptide/protein/enzyme
- Orphan Drug
- Yes
Key dates
- Initial CTIS Submission Date
- 01-12-2023
- First CTIS Authorization Date
- 23-01-2024
Trial design
open-label, adaptive Phase I/II trial across 41 sites in Finland, France, Norway and others.
- Open Label
- Yes
- Adaptive
- True - includes a dose escalation phase (DLT assessment) followed by expansion cohorts; specific escalation rules or stopping rules not provided in the supplied data
- Biomarker Stratified
- True, CD20 positivity required (CD20-positive NHL)
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 188
- Trial Duration For Participant
- 730
Eligibility
Recruits 188 Vulnerable population flag selected. Subjects must sign an informed consent form (ICF). Trial enrols adults (≥18 years). Consent materials and ICFs are provided (multiple country/language versions available). No information on assent or parental consent for minors is provided in the supplied data..
- Vulnerable Population
- Vulnerable population flag selected. Subjects must sign an informed consent form (ICF). Trial enrols adults (≥18 years). Consent materials and ICFs are provided (multiple country/language versions available). No information on assent or parental consent for minors is provided in the supplied data.
Inclusion criteria
- {"criterion_text":"- Subject must sign an ICF"}
- {"criterion_text":"- At least 18 years of age"}
- {"criterion_text":"- Measurable disease defined as ≥1 measurable nodal lesion (long axis >1.5 cm and short axis >1.0 cm) or ≥1 measurable extra-nodal lesion (long axis >1.0 cm) on CT or MRI"}
- {"criterion_text":"- ECOG PS score of 0, 1 or 2"}
- {"criterion_text":"- Acceptable organ function at screening"}
- {"criterion_text":"- CD20-positive NHL at most recent representative tumor biopsy"}
- {"criterion_text":"- If of childbearing potential subject must practicing a highly effective method of birth control"}
- {"criterion_text":"- A man who is sexually active with a woman of childbearing potential must agree to use a barrier method of birth control"}
- {"criterion_text":"- Life expectancy >2 months with SOC treatment. Arm 1: One of these confirmed histologies: - DLBCL, NOS - T-cell/histiocyte rich DLBCL - \"double-hit\" or \"triple-hit\" DLBCL - FL Grade 3B Arm 2 and Arm 9: R/R FL Arm 3: Newly diagnosed, previously untreated FL grade 1-3A Arm 4 and Arm 10: One of these confirmed histologies and eligible for HDT-ASCT - DLBCL, NOS - T-cell/histiocyte rich DLBCL - \"double-hit\" or \"triple-hit\" DLBCL - FL Grade 3B Arm 5: One of these confirmed histologies and ineligible for HDT-ASCT - DLBCL, NOS - T-cell/histiocyte rich DLBCL - \"double-hit\" or \"triple-hit\" DLBCL - FL Grade 3B Arm 6: previously untreated CD20+ FL Arm 7: FL and in CR or PR per Lugano criteria following first-line or second-line treatment with SOC regiment at last treatment received, and last dose of SOC within 6 months prior to enrollment Arm 8: One of these confirmed histologies: - DLBCL, NOS - T-cell/histiocyte rich DLBCL - \"double-hit\" or \"triple-hit\" DLBCL -FL Grade 3B For Arm8, subjects must be ineligible to receive full-dose anthracycline (as part of R-CHOP) per eligibility criteria Arm 9: Must have received only 1 prior line of therapy. This first-line therapy must have included an anti-CD20 antibody in combination with chemotherapy. Progressed within 24 months of initiating first-line treatment"}
Exclusion criteria
- {"criterion_text":"- Chemotherapy, radiation therapy, or major surgery within 4 weeks prior to the first dose of epcoritamab"}
- {"criterion_text":"- Subject has current seizure disorder requiring anti-epileptic therapy"}
- {"criterion_text":"- Any prior treatment with a bispecific antibody targeting CD3 and CD20."}
- {"criterion_text":"- Treatment with CAR-T therapy within 100 days prior to first dose of epcoritamab"}
- {"criterion_text":"- Clinically significant cardiovascular disease"}
- {"criterion_text":"- Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results"}
- {"criterion_text":"- Primary CNS lymphoma or known CNS involvement by lymphoma at screening as confirmed by MRI/CT scan of the brain and, if clinically indicated, by lumbar puncture"}
- {"criterion_text":"- Active HBV or HCV (DNA PCR positive infection)"}
- {"criterion_text":"- Known history of seropositivity for human immunodeficiency virus (HIV)"}
- {"criterion_text":"- Active tuberculosis or history of completed treatment for active tuberculosis within the past 12 months"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Dose Escalation Phase: - Incidence of dose-limiting toxicities - Incidence and severity of adverse events (AEs) - Incidence and severity of changes in laboratory values - Incidence of dose interruptions and delays","definition_or_measurement_approach":"Safety endpoints (DLTs, AEs, lab changes, dose interruptions/delays) recorded and reported during Dose Escalation Phase; specific measurement rules not provided in supplied data"}
- {"endpoint_text":"- Expansion Phase: Arms 1-6 and 8-10: - ORR determined by Lugano criteria Arm 7: - Incidence and severity of AEs - Incidence and severity of changes in laboratory values - Incidence of dose interruptions and delays","definition_or_measurement_approach":"ORR assessed per Lugano criteria (explicitly stated). Safety endpoints recorded as incidence and severity; specific schedules/methods not provided beyond Lugano criteria for ORR."}
Secondary endpoints
- {"endpoint_text":"- Dose Escalation Phase:- PK parameters- Pharmacodynamic markers in blood samples and within tumor (ontreatment biopsy)- Incidence of anti-drug antibodies (ADAs) to epcoritamab- ORR determined by Lugano criteria- Duration of response (DOR) determined by Lugano criteria- Time to response (TTR) determined by Lugano criteria- Progression-free survival (PFS) determined by Lugano criteria- Overall survival (OS)- TTNT- Rate and duration of minimal residual disease (MRD) negativity","definition_or_measurement_approach":"PK parameters measured from blood samples; pharmacodynamic markers in blood and on-treatment tumor biopsies; ADA incidence measured; efficacy endpoints (ORR, DOR, TTR, PFS) determined by Lugano criteria; MRD measures and TTNT specified but exact assays/timepoints not detailed here."}
- {"endpoint_text":"- Expansion Phase:-DOR determined by Lugano criteria (Arms 1-6 and 8-10)-TTR determined by Lugano criteria (Arms 1-6 and 8-10)-PFS determined by Lugano criteria (Arms 1-6 and 8-10)-CR rate (Arm 1-10 except Arm 7 subjects in CR at baseline)-OS (Arms 1-10)-TTNT (Arms 1-10)-Rate and duration of MRD negativity (Arms 1-10)-Rate of conversion from MRD positivity to MRD negativity (Arm 7)-CR rate (Arm 7 subjects in PR at baseline)-TTCR (Arms 1-10 except Arm 7 subjects in CR at baseline)-DoCR (Arms 1-10)","definition_or_measurement_approach":"Multiple efficacy measures specified for Expansion Phase primarily determined by Lugano criteria; MRD and TTNT endpoints included; specific measurement details not provided in the JSON."}
- {"endpoint_text":"- Incidence and severity of AEs (Arms 1-6, and 8-10) -Incidence and severity of changes in laboratory values (Arms 1-6, and 8-10) -Incidence of dose interruptions and delays (Arms 1-6, and 8-10)","definition_or_measurement_approach":"Safety endpoints recorded by incidence and severity; specific grading scale not stated in provided data (commonly CTCAE but not specified here)."}
- {"endpoint_text":"- PK parameters","definition_or_measurement_approach":"Pharmacokinetic parameters to be measured from blood samples; specific PK parameters and sampling schedule not provided in the JSON."}
- {"endpoint_text":"- Pharmacodynamic markers in blood samples and within tumor (on treatment biopsy)","definition_or_measurement_approach":"PD markers assessed in blood and tumor biopsies during treatment; specific markers not listed in the provided data."}
- {"endpoint_text":"- Incidence of ADAs to epcoritamab","definition_or_measurement_approach":"Incidence of anti-drug antibodies to epcoritamab assessed; assay details not provided in the supplied data."}
Recruitment
- Planned Sample Size
- 188
- Recruitment Window Months
- 96
- Consent Approach
- Subjects must sign an informed consent form (ICF). ICF and subject information materials exist in multiple country/language versions (documents in EN, FR, NL, CZ, DK, FI, IT, NO, SE, ES are present). Trial enrols adults (≥18); no assent/parental consent procedures for minors are provided in the supplied data.
Methods
- Site-based recruitment at participating hospitals/clinics (multiple hospital sites listed across countries)
- Physician referral (recruitment materials include a 'Physician Referral Letter' document)
Geography
- Total Number Of Sites
- 41
- Total Number Of Participants
- 367
Finland
- Earliest CTIS Part Ii Submission Date
- 14-12-2023
- Latest Decision Or Authorization Date
- 08-04-2026
- Processing Time Days
- 846
- Number Of Sites
- 2
- Number Of Participants
- 11
Sites
- Site Name
- Kuopio University Hospital
- Department Name
- Department of Oncology
- Principal Investigator Name
- Outi Kuittinen
- Principal Investigator Email
- outi.kuittinen@kuh.fi
- Contact Person Name
- Outi Kuittinen
- Contact Person Email
- outi.kuittinen@kuh.fi
- Site Name
- HUS-Yhtymae
- Department Name
- Department of Oncology
- Principal Investigator Name
- Sirpa Leppä
- Principal Investigator Email
- sirpa.leppa@hus.fi
- Contact Person Name
- Sirpa Leppä
- Contact Person Email
- sirpa.leppa@hus.fi
France
- Earliest CTIS Part Ii Submission Date
- 14-12-2023
- Latest Decision Or Authorization Date
- 31-03-2026
- Processing Time Days
- 838
- Number Of Sites
- 4
- Number Of Participants
- 17
Sites
- Site Name
- Centre Hospitalier Lyon Sud
- Department Name
- Clinical Hematology
- Principal Investigator Name
- Hervé GHESQUIERES
- Principal Investigator Email
- Herve.ghesquieres@chu-lyon.fr
- Contact Person Name
- Hervé GHESQUIERES
- Contact Person Email
- Herve.ghesquieres@chu-lyon.fr
- Site Name
- Assistance Publique Hopitaux De Marseille
- Department Name
- Phase I
- Principal Investigator Name
- Regis COSTELLO
- Principal Investigator Email
- Regis.COSTELLO@ap-hm.fr
- Contact Person Name
- Regis COSTELLO
- Contact Person Email
- Regis.COSTELLO@ap-hm.fr
- Site Name
- Centre Hospitalier Universitaire De Lille
- Department Name
- Blood Diseases
- Principal Investigator Name
- Franck MORSCHHAUSER
- Principal Investigator Email
- Franck.MORSCHHAUSER@CHRU-LILLE.FR
- Contact Person Name
- Franck MORSCHHAUSER
- Contact Person Email
- Franck.MORSCHHAUSER@CHRU-LILLE.FR
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Oncology-Hematology
- Principal Investigator Name
- Catherine THIEBLEMONT
- Principal Investigator Email
- catherine.thieblemont@ap-hp.fr
- Contact Person Name
- Catherine THIEBLEMONT
- Contact Person Email
- catherine.thieblemont@ap-hp.fr
Norway
- Earliest CTIS Part Ii Submission Date
- 14-12-2023
- Latest Decision Or Authorization Date
- 27-03-2026
- Processing Time Days
- 834
- Number Of Sites
- 1
- Number Of Participants
- 10
Sites
- Site Name
- Oslo University Hospital HF
- Department Name
- Oslo Universitetssykehus HF, Radiumhospitalet
- Principal Investigator Name
- Alexander Fosså
- Principal Investigator Email
- AFF@ous-hf.no
- Contact Person Name
- Alexander Fosså
- Contact Person Email
- AFF@ous-hf.no
Italy
- Earliest CTIS Part Ii Submission Date
- 14-12-2023
- Latest Decision Or Authorization Date
- 30-03-2026
- Processing Time Days
- 837
- Number Of Sites
- 7
- Number Of Participants
- 41
Sites
- Site Name
- Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
- Department Name
- Hematology
- Principal Investigator Name
- Francesca Gaia Rossi Dardanoni
- Principal Investigator Email
- francescagaia.rossi@policlinico.mi.it
- Contact Person Name
- Francesca Gaia Rossi Dardanoni
- Contact Person Email
- francescagaia.rossi@policlinico.mi.it
- Site Name
- Azienda Ospedaliera Papa Giovanni XXIII
- Department Name
- U.O. di Ematologia
- Principal Investigator Name
- Giuseppe Gritti
- Principal Investigator Email
- g.gritti@asst-pg23.it
- Contact Person Name
- Giuseppe Gritti
- Contact Person Email
- g.gritti@asst-pg23.it
- Site Name
- Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
- Department Name
- Ematologia
- Principal Investigator Name
- Gerardo Musuraca
- Principal Investigator Email
- gerardo.musuraca@irst.emr.it
- Contact Person Name
- Gerardo Musuraca
- Contact Person Email
- gerardo.musuraca@irst.emr.it
- Site Name
- Fondazione IRCCS Policlinico San Matteo
- Department Name
- Ematologia
- Principal Investigator Name
- Luca Arcaini
- Principal Investigator Email
- luca.arcaini@unipv.it
- Contact Person Name
- Luca Arcaini
- Contact Person Email
- luca.arcaini@unipv.it
- Site Name
- Azienda USL IRCCS Di Reggio Emilia
- Department Name
- Ematologia
- Principal Investigator Name
- Stefano Luminari
- Principal Investigator Email
- luminari.stefano@asmn.re.it
- Contact Person Name
- Stefano Luminari
- Contact Person Email
- luminari.stefano@asmn.re.it
- Site Name
- Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS
- Department Name
- Div. di Oncologia Medica ed Ematologia
- Principal Investigator Name
- Umberto Vitolo
- Principal Investigator Email
- umberto.vitolo@ircc.it
- Contact Person Name
- Umberto Vitolo
- Contact Person Email
- umberto.vitolo@ircc.it
- Site Name
- Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
- Department Name
- U.O.C. Ematologia
- Principal Investigator Name
- Luigi Zinzani
- Principal Investigator Email
- pierluigi.zinzani@unibo.it
- Contact Person Name
- Luigi Zinzani
- Contact Person Email
- pierluigi.zinzani@unibo.it
Netherlands
- Earliest CTIS Part Ii Submission Date
- 14-12-2023
- Latest Decision Or Authorization Date
- 30-03-2026
- Processing Time Days
- 837
- Number Of Sites
- 6
- Number Of Participants
- 55
Sites
- Site Name
- Amsterdam UMC
- Department Name
- Hematology
- Principal Investigator Name
- Martine Chamuleau
- Principal Investigator Email
- m.chamuleau@amsterdamumc.nl
- Contact Person Name
- Martine Chamuleau
- Contact Person Email
- m.chamuleau@amsterdamumc.nl
- Site Name
- Universiteit Maastricht
- Department Name
- Hematology
- Principal Investigator Name
- Marjolein van der Poel
- Principal Investigator Email
- marjolein.vander.poel@mumc.nl
- Contact Person Name
- Marjolein van der Poel
- Contact Person Email
- marjolein.vander.poel@mumc.nl
- Site Name
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Department Name
- Hematology
- Principal Investigator Name
- Pieternella Lugtenburg
- Principal Investigator Email
- p.lugtenburg@erasmusmc.nl
- Contact Person Name
- Pieternella Lugtenburg
- Contact Person Email
- p.lugtenburg@erasmusmc.nl
- Site Name
- Universitair Medisch Centrum Groningen
- Department Name
- Hematology
- Principal Investigator Name
- Marcel Nijland
- Principal Investigator Email
- m.nijland@umcg.nl
- Contact Person Name
- Marcel Nijland
- Contact Person Email
- m.nijland@umcg.nl
- Site Name
- Academisch Ziekenhuis Leiden
- Department Name
- Hematology
- Principal Investigator Name
- Joost Vermaat
- Principal Investigator Email
- J.S.P.Vermaat@lumc.nl
- Contact Person Name
- Joost Vermaat
- Contact Person Email
- J.S.P.Vermaat@lumc.nl
- Site Name
- Utrecht University
- Department Name
- Hematology
- Principal Investigator Name
- Rimke Oostvogels
- Principal Investigator Email
- r.oostvogels@umcutrecht.nl
- Contact Person Name
- Rimke Oostvogels
- Contact Person Email
- r.oostvogels@umcutrecht.nl
Belgium
- Earliest CTIS Part Ii Submission Date
- 14-12-2023
- Latest Decision Or Authorization Date
- 30-03-2026
- Processing Time Days
- 837
- Number Of Sites
- 3
- Number Of Participants
- 29
Sites
- Site Name
- Az St-Jan Brugge-Oostende A.V.
- Department Name
- Hematology
- Principal Investigator Name
- Sylvia Snauwaert
- Principal Investigator Email
- sylvia.snauwaert@azsintjan.be
- Contact Person Name
- Sylvia Snauwaert
- Contact Person Email
- sylvia.snauwaert@azsintjan.be
- Site Name
- Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
- Department Name
- Hematology
- Principal Investigator Name
- Marc Andre
- Principal Investigator Email
- marc.andre@chuuclnamur.uclouvain.be
- Contact Person Name
- Marc Andre
- Contact Person Email
- marc.andre@chuuclnamur.uclouvain.be
- Site Name
- Universitair Ziekenhuis Gent
- Department Name
- Hematology
- Principal Investigator Name
- Fritz Offner
- Principal Investigator Email
- fritz.offner@ugent.be
- Contact Person Name
- Fritz Offner
- Contact Person Email
- fritz.offner@ugent.be
Denmark
- Earliest CTIS Part Ii Submission Date
- 14-12-2023
- Latest Decision Or Authorization Date
- 29-03-2026
- Processing Time Days
- 836
- Number Of Sites
- 4
- Number Of Participants
- 45
Sites
- Site Name
- Aarhus Universitetshospital
- Department Name
- Department of Hematology
- Principal Investigator Name
- Judit Jørgensen
- Principal Investigator Email
- judijoer@rm.dk
- Contact Person Name
- Judit Jørgensen
- Contact Person Email
- judijoer@rm.dk
- Site Name
- Sygehus Lillebaelt Vejle Sygehus
- Department Name
- Department of Hematology
- Principal Investigator Name
- Michael Clausen
- Principal Investigator Email
- michael.roost.clausen@rsyd.dk
- Contact Person Name
- Michael Clausen
- Contact Person Email
- michael.roost.clausen@rsyd.dk
- Site Name
- Odense University Hospital
- Department Name
- Department of Hematology
- Principal Investigator Name
- Jacob Haaber Christensen
- Principal Investigator Email
- jacob.h.christensen@rsyd.dk
- Contact Person Name
- Jacob Haaber Christensen
- Contact Person Email
- jacob.h.christensen@rsyd.dk
- Site Name
- Rigshospitalet
- Department Name
- Department of Hematology
- Principal Investigator Name
- Martin Hutchings
- Principal Investigator Email
- martin.hutchings@regionh.dk
- Contact Person Name
- Martin Hutchings
- Contact Person Email
- martin.hutchings@regionh.dk
Spain
- Earliest CTIS Part Ii Submission Date
- 14-12-2023
- Latest Decision Or Authorization Date
- 01-04-2026
- Processing Time Days
- 839
- Number Of Sites
- 5
- Number Of Participants
- 66
Sites
- Site Name
- Hospital Universitario La Paz
- Department Name
- Hematology
- Principal Investigator Name
- Pilar Gómez Prieto
- Principal Investigator Email
- pilargp84@gmail.com
- Contact Person Name
- Pilar Gómez Prieto
- Contact Person Email
- pilargp84@gmail.com
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Hematology
- Principal Investigator Name
- Pau Abrisqueta Costa
- Principal Investigator Email
- pabrisqueta@vhio.net
- Contact Person Name
- Pau Abrisqueta Costa
- Contact Person Email
- pabrisqueta@vhio.net
- Site Name
- Hospital Universitario Fundacion Jimenez Diaz
- Department Name
- Oncology
- Principal Investigator Name
- Daniel Morillo Giles
- Principal Investigator Email
- dmorillo@startmadrid.com
- Contact Person Name
- Daniel Morillo Giles
- Contact Person Email
- dmorillo@startmadrid.com
- Site Name
- Hospital Universitario De Salamanca
- Department Name
- Hematology
- Principal Investigator Name
- Alejandro Martin García-Sancho
- Principal Investigator Email
- amartingar@usal.es
- Contact Person Name
- Alejandro Martin García-Sancho
- Contact Person Email
- amartingar@usal.es
- Site Name
- Institut Catala D'oncologia
- Department Name
- Hematology
- Principal Investigator Name
- Anna Sureda Balari
- Principal Investigator Email
- asureda@iconcologia.net
- Contact Person Name
- Anna Sureda Balari
- Contact Person Email
- asureda@iconcologia.net
Czechia
- Earliest CTIS Part Ii Submission Date
- 14-12-2023
- Latest Decision Or Authorization Date
- 31-03-2026
- Processing Time Days
- 838
- Number Of Sites
- 4
- Number Of Participants
- 53
Sites
- Site Name
- Fakultni Nemocnice V Motole
- Department Name
- Onkologická klinika
- Principal Investigator Name
- Kateřina Kopečková
- Principal Investigator Email
- katerina.kopeckova@fnmotol.cz
- Contact Person Name
- Kateřina Kopečková
- Contact Person Email
- katerina.kopeckova@fnmotol.cz
- Site Name
- Fakultni Nemocnice Hradec Kralove
- Department Name
- IV. interní hematologická klinika
- Principal Investigator Name
- David Belada
- Principal Investigator Email
- david.belada@fnhk.cz
- Contact Person Name
- David Belada
- Contact Person Email
- david.belada@fnhk.cz
- Site Name
- Fakultni Nemocnice Ostrava
- Department Name
- Klinika hematoonkologie
- Principal Investigator Name
- Juraj Ďuraš
- Principal Investigator Email
- juraj.duras@fno.cz
- Contact Person Name
- Juraj Ďuraš
- Contact Person Email
- juraj.duras@fno.cz
- Site Name
- Vseobecna Fakultni Nemocnice V Praze
- Department Name
- I. interní klinika – hematologie
- Principal Investigator Name
- Marek Trněný
- Principal Investigator Email
- trneny@cesnet.cz
- Contact Person Name
- Marek Trněný
- Contact Person Email
- trneny@cesnet.cz
Sweden
- Earliest CTIS Part Ii Submission Date
- 14-12-2023
- Latest Decision Or Authorization Date
- 27-03-2026
- Processing Time Days
- 834
- Number Of Sites
- 5
- Number Of Participants
- 40
Sites
- Site Name
- Karolinska University Hospital
- Department Name
- Studiebehandlingsenheten B8:09
- Principal Investigator Name
- Björn Wahlin
- Principal Investigator Email
- bjorn.wahlin@sll.se
- Contact Person Name
- Björn Wahlin
- Contact Person Email
- bjorn.wahlin@sll.se
- Site Name
- Sodra Alvsborg Hospital-Vastra Gotalandsregionen
- Department Name
- Hematolog dagvård
- Principal Investigator Name
- Per-Ola Andersson
- Principal Investigator Email
- per-ola.andersson@vgregion.se
- Contact Person Name
- Per-Ola Andersson
- Contact Person Email
- per-ola.andersson@vgregion.se
- Site Name
- Uppsala University Hospital
- Department Name
- Kliniska forsknings- och utvecklingsenheten
- Principal Investigator Name
- Mats Hellström
- Principal Investigator Email
- mats.hellstrom@akademiska.se
- Contact Person Name
- Mats Hellström
- Contact Person Email
- mats.hellstrom@akademiska.se
- Site Name
- Sahlgrenska University Hospital-Vastra Gotalandsregionen
- Department Name
- Sektionen för Hematologi och Koagulation, Forskningsenhet Hematologi
- Principal Investigator Name
- Catharina Lewerin
- Principal Investigator Email
- catharina.lewerin@vgregion.se
- Contact Person Name
- Catharina Lewerin
- Contact Person Email
- catharina.lewerin@vgregion.se
- Site Name
- Region Skane Skanes Universitetssjukhus
- Department Name
- Department of Oncology
- Principal Investigator Name
- Kristina Drott
- Principal Investigator Email
- kristina.drott@med.lu.se
- Contact Person Name
- Kristina Drott
- Contact Person Email
- kristina.drott@med.lu.se
Sponsor
Primary sponsor
- Full Name
- Genmab A/S
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Denmark
Contract research organisations
- Name
- IQVIA Limited
- Responsibilities
- Project management, expedited and aggregate safety reporting to investigators and ECs; additional sponsor duties codes: [1,11,12,2,5,7]
- Name
- Icon Clinical Research Limited
- Responsibilities
- Responsibilities code: [4]
- Name
- Clinipace Inc.
- Responsibilities
- Responsibilities code: [10]
- Name
- Endpoint Clinical Inc.
- Responsibilities
- Responsibilities code: [3]
Third parties
- {"country":"United Kingdom","full_name":"Fortrea Development Limited","duties_or_roles":"Sponsor duties codes: [8]; contact info: info@labcorp.com","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"Sponsor duties codes: [1,11,12,15(value: Project management, expedited and aggregate safety reporting to investigators and ECs),2,5,7]; contact: eu_clinical_trials_information@iqvia.com","organisation_type":"Pharmaceutical company"}
- {"country":"Denmark","full_name":"Klifo A/S","duties_or_roles":"Sponsor duties codes: [14]; contact: Tove.andersen@klifo.com","organisation_type":"Pharmaceutical company"}
- {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"Sponsor duties codes: [4]; contact: ladaina.rosoboro@iconplc.com","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"Sponsor duties codes: [15(value: Central ECG and ePRO)]; contact: customercare@ert.com","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Clinipace Inc.","duties_or_roles":"Sponsor duties codes: [10]; contact: info@caidya.com","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Adaptive Biotechnologies Corp.","duties_or_roles":"Sponsor duties codes: [15(value: FFPE for MRD, plasma for MRD, aspirate for MRD & whole blood for TCR Sequencing),4]; contact: regulatory@adaptivebiotech.com","organisation_type":"Pharmaceutical company"}
- {"country":"Belgium","full_name":"CellCarta","duties_or_roles":"Sponsor duties codes: [15(value: FFPE for IHC),4]; contact: info@cellcarta.com","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Endpoint Clinical Inc.","duties_or_roles":"Sponsor duties codes: [3]; contact: info@endpointclinical.com","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Perceptive Informatics Inc.","duties_or_roles":"Sponsor duties codes: [15(value: Central Imaging Reading)]; contact: Jeyme.zuleta@calyx.ai","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Q Squared Solutions Limited","duties_or_roles":"Sponsor duties codes: [4]; contact: q2_eu_clinical_trials_information@q2labsolutions.com","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Bioagilytix Labs LLC","duties_or_roles":"Sponsor duties codes: [4]; contact: mychal.feeny@bioagilytix.com","organisation_type":"Pharmaceutical company"}
- {"country":"Netherlands","full_name":"ICON Bioanalytical Laboratories","duties_or_roles":"Sponsor duties codes: [15(value: PK and ADA samples)]; contact: Wikke.Koopmans@iconplc.com","organisation_type":"Health care"}
Investigational products
- Investigational Product Name
- Epcoritamab
- Active Substance
- EPCORITAMAB
- Modality
- Bispecific antibody
- Routes Of Administration
- Subcutaneous
- Route
- Subcutaneous
- Authorisation Status
- Authorised (prodAuthStatus: 1)
- Orphan Designation
- Yes
- Investigational Product Name
- GEMCITABINE
- Active Substance
- GEMCITABINE HYDROCHLORIDE
- Modality
- Small molecule
- Routes Of Administration
- Intravenous
- Route
- Intravenous
- Investigational Product Name
- BENDAMUSTINE
- Active Substance
- BENDAMUSTINE HYDROCHLORIDE
- Modality
- Small molecule
- Routes Of Administration
- Intravenous
- Route
- Intravenous
- Investigational Product Name
- CYTARABINE
- Active Substance
- CYTARABINE
- Modality
- Small molecule
- Routes Of Administration
- Intravenous
- Route
- Intravenous
- Investigational Product Name
- OXALIPLATIN
- Active Substance
- OXALIPLATIN
- Modality
- Small molecule
- Routes Of Administration
- Intravenous
- Route
- Intravenous
- Investigational Product Name
- CYCLOPHOSPHAMIDE
- Active Substance
- CYCLOPHOSPHAMIDE
- Modality
- Small molecule
- Routes Of Administration
- Intravenous
- Route
- Intravenous
- Investigational Product Name
- DOXORUBICIN
- Active Substance
- DOXORUBICIN HYDROCHLORIDE
- Modality
- Small molecule
- Routes Of Administration
- Intravenous
- Route
- Intravenous
- Investigational Product Name
- CARBOPLATIN
- Active Substance
- CARBOPLATIN
- Modality
- Small molecule
- Routes Of Administration
- Intravenous
- Route
- Intravenous
- Investigational Product Name
- ETOPOSIDE
- Active Substance
- ETOPOSIDE
- Modality
- Small molecule
- Routes Of Administration
- Intravenous
- Route
- Intravenous
- Investigational Product Name
- IFOSFAMIDE
- Active Substance
- IFOSFAMIDE
- Modality
- Small molecule
- Routes Of Administration
- Intravenous
- Route
- Intravenous
- Investigational Product Name
- RITUXIMAB
- Active Substance
- RITUXIMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- Intravenous
- Route
- Intravenous
- Investigational Product Name
- VINORELBINE
- Active Substance
- VINORELBINE
- Modality
- Small molecule
- Routes Of Administration
- Intravenous
- Route
- Intravenous
- Investigational Product Name
- LENALIDOMIDE
- Active Substance
- LENALIDOMIDE
- Modality
- Small molecule
- Routes Of Administration
- Oral
- Route
- Oral
- Investigational Product Name
- DEXAMETHASONE
- Active Substance
- DEXAMETHASONE ISONICOTINATE
- Modality
- Small molecule
- Routes Of Administration
- Intravenous
- Route
- Intravenous
- Investigational Product Name
- PREDNISONE
- Active Substance
- PREDNISOLONE
- Modality
- Small molecule
- Routes Of Administration
- Intravenous
- Route
- Intravenous
- Combination Treatment
- Yes
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