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GEN3013, studio con Epcoritamab in pazienti con linfoma a cellule B recidivato, progressivo o refrattario EPCORE™ NHL-1 (EPCORE™ NHL-1)

2 novembre 2026 aggiornato da: Genmab

Uno studio di sicurezza in aperto di fase 1/2 di GEN3013 in pazienti con linfoma a cellule B recidivato, progressivo o refrattario EPCORE™NHL-1

The purpose of this trial is to measure the following in participants with relapsed and/or refractory B-cell lymphoma who receive epcoritamab, an antibody also known as EPKINLY™ and GEN3013 (DuoBody®-CD3xCD20):

  • The dose schedule for epcoritamab
  • The side effects seen with epcoritamab
  • What the body does with epcoritamab once it is administered
  • What epcoritamab does to the body once it is administered
  • How well epcoritamab works against relapsed and/or refractory B-cell lymphoma

The trial consists of 3 parts:

  • a dose-escalation part (Phase 1, first-in-human [FIH])
  • an expansion part (Phase 2a)
  • a dose-optimization part (OPT) (Phase 2a)

The trial time for each participant depends on which trial part the participant enters:

  • For the dose-escalation part, each participant will be in the trial for approximately 1 year, which is made up of 21 days of screening, 6 months of treatment (the total time of treatment may be different for each participant), and 6 months of follow-up (the total time of follow-up may be different for each participant).
  • For the expansion and dose-OPT parts, each participant will be in the trial for approximately 1.5 years, which is made up of 21 days of screening, 1 year of treatment (the total time of treatment may be different for each participant), and 6 months of follow-up (the total time of follow-up may be different for each participant).

Participation in the study will require visits to the sites. During the first month, participants must visit every day or every few days, depending on which trial part the participant enters. After that, participants must visit weekly, every other week, once a month, and once every 2 months, as trial participation ends.

All participants will receive active drug, and no participants will be given placebo.

Panoramica dello studio

Stato

Attivo, non reclutante

Condizioni

Intervento / Trattamento

Descrizione dettagliata

The purpose of the dose-escalation part of the trial is to determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D), as well as to establish the safety profile of epcoritamab in participants with relapsed or refractory B-cell lymphoma.

In the expansion part, additional participants will be treated with epcoritamab, at the RP2D and the purpose is to further explore and determine the safety and efficacy of epcoritamab.

The dose-OPT part will evaluate alternative priming and intermediate dose regimens of epcoritamab in participants with:

  • Diffuse large B-cell lymphoma (DLBCL)
  • Follicular lymphoma (FL)
  • Mantle cell lymphoma (MCL)

All participants will receive epcoritamab at the RP2D.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

666

Fase

  • Fase 2
  • Fase 1

Accesso esteso

Approvato per la vendita al pubblico. Vedi record di accesso esteso.

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Australia
      • Clayton, Australia
        • Monash Health
      • Concord, Australia
        • Concord Hospital
      • Fitzroy, Australia
        • St. Vincent Hospital
      • Herston, Australia
        • Royal Brisbane and Women's Hospital
      • Hobart, Australia
        • Royal Hobart Hospital RHH
      • Kogarah, Australia
        • St. George Hospital
      • Malvern, Australia
        • Cabrini Hospital
      • Nedlands, Australia
        • Sir Charles Gairdner Hospital
      • Southport, Australia
        • Gold Coast Hospital
      • Sydney, Australia
        • Westmead Hospital
  • Canada
      • Calgary, Canada
        • Tom Baker Cancer Care
      • Toronto, Canada
        • Toronto-Sunnybrook Regional Cancer Ctr
  • Corea del Sud
      • Busan, Corea del Sud
        • Dong-A University Hospital
      • Daegu, Corea del Sud
        • Keimyung University Dongsan Medical Center
      • Goyang-si, Corea del Sud
        • National Cancer Center
      • Jeonju, Corea del Sud
        • Chonbuk National University Hospital
      • Seongnam-si, Corea del Sud
        • Seoul National University Bundang Hospital
      • Seoul, Corea del Sud
        • Asan Medical Center
      • Seoul, Corea del Sud
        • Samsung Medical Center
      • Seoul, Corea del Sud
        • Seoul National University Hospital
      • Seoul, Corea del Sud
        • Severance Hospital, Yonsei University
  • Danimarca
      • Copenhagen, Danimarca
        • Rigshospitalet
      • Odense, Danimarca, 5000 C
        • Odense University Hospital
      • Vejle, Danimarca
        • Vejle Hospital
  • Finlandia
      • Helsinki, Finlandia
        • Helsinki University Hospital
      • Kuopio, Finlandia
        • Kuopio University Hospital
      • Tampere, Finlandia
        • Tampere University Hospital
  • Francia
      • Créteil, Francia
        • Hopital Henri Mondor
      • Montpellier, Francia
        • CHU Montpellier
      • Paris, Francia
        • Hospital Saint-Louis
      • Pierre-Bénite, Francia
        • Hospices Civils de Lyon Centre Hospitalier Lyon Sud
      • Rouen, Francia
        • Centre Henri Becquerel
      • Tours, Francia
        • CHU de Tours-Hopital Bretonneau
  • Germania
      • Berlin, Germania
        • Charite - Universitaetsmedizin Berlin
      • Berlin, Germania
        • Klinik fur Innere Medizin Hamatologie and Onkologie
      • Cologne, Germania
        • Universitaetsklinikum Koeln
      • Essen, Germania
        • Universitaetsklinikum Essen
      • Mainz, Germania
        • Johannes Gutenberg University
      • München, Germania
        • Der Universität Munchen Medizinische Klinik III LMU
  • Italia
      • Alessandria, Italia
        • Ao Ss Antonio E Biagio Alessandria
      • Bologna, Italia
        • Policlinico S. Orsola-Ematologia LA Seragnoli
      • Candiolo, Italia
        • Istituto di Candiolo- Fondazione del Piemonte per l'Oncologia
      • Meldola, Italia
        • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
      • Milan, Italia
        • IRCCS Ospedale San Raffaele
  • Olanda
      • Amsterdam, Olanda
        • VU University Medical Center
      • Maastricht, Olanda, 6229 HX
        • Maastricht University Medical Center
      • Rotterdam, Olanda
        • Erasmus MC Cancer Institute
      • Utrecht, Olanda
        • Universitair Medisch Centrum Utrecht
  • Polonia
      • Bydgoszcz, Polonia
        • Szpital Uniwersytecki nr 2 im dr. Jana Biziela
      • Gdansk, Polonia
        • Uniwersyteckie Centrum Kliniczne
      • Krakow, Polonia
        • Pratia-McM
      • Słupsk, Polonia
        • Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka
      • Warsaw, Polonia
        • Maria Sklodowska-Curie Memorial Cancer Center and Institute
      • Wroclaw, Polonia
        • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego
  • Regno Unito
      • Manchester, Regno Unito
        • The Christie NHS Foundation Trust
      • Plymouth, Regno Unito
        • Plymouth University School of Medicine- Derriford Hospital
      • Southampton, Regno Unito
        • University Hospital Southampton NHS Foundation Trust
      • Sutton, Regno Unito
        • Royal Marsden NHS Foundation Trust
  • Singapore
      • Singapore, Singapore
        • National University Hospital
      • Singapore, Singapore
        • Singapore General Hospital
  • Spagna
      • Badalona, Spagna
        • Hospital Germans Trias i Pujol
      • Barcelona, Spagna
        • Institut Catala de Oncologia
      • Barcelona, Spagna
        • Hospital Universitario Vall dHebron
      • Madrid, Spagna
        • Hospital Universitario Fundacin Jimnez Daz
    • Navarre
      • Pamplona, Navarre, Spagna, 31008
        • Clinica Universidad de Navarra
  • Stati Uniti
    • Arizona
      • Phoenix, Arizona, Stati Uniti, 85054
        • Arizona Mayo Clinic
    • California
      • San Francisco, California, Stati Uniti, 94117
        • University of California at San Francisco
    • Colorado
      • Denver, Colorado, Stati Uniti, 80218
        • Colorado Blood Cancer Institute
    • Florida
      • Tampa, Florida, Stati Uniti, 33612
        • H. Lee Moffitt Cancer Center and Research Institute
    • Iowa
      • Iowa City, Iowa, Stati Uniti, 52242
        • University of Iowa Hospital and Clinics
    • Louisiana
      • New Orleans, Louisiana, Stati Uniti, 70121
        • Ochsner Medical Center
    • Michigan
      • Ann Arbor, Michigan, Stati Uniti, 48109
        • University of Michigan
      • Detroit, Michigan, Stati Uniti, 48334
        • Barbara Ann Karmanos Cancer Institute
    • Nebraska
      • Omaha, Nebraska, Stati Uniti, 68198
        • University of Nebraska Medical Center
    • New Jersey
      • Hackensack, New Jersey, Stati Uniti, 07601
        • Hackensack Meridian Health
    • Ohio
      • Cleveland, Ohio, Stati Uniti, 44195
        • The Cleveland Clinic Foundation
    • Oregon
      • Portland, Oregon, Stati Uniti, 97210
        • OHSU Knight Cancer Institute
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Stati Uniti, 15232
        • Hillman Cancer Center
    • Rhode Island
      • Providence, Rhode Island, Stati Uniti, 02903
        • Rhode Island Hospital
    • South Carolina
      • Charleston, South Carolina, Stati Uniti, 29425
        • Medical University of South Carolina
    • Texas
      • Dallas, Texas, Stati Uniti, 75390
        • UT Southwestern
      • Houston, Texas, Stati Uniti, 77030
        • MD Anderson Cancer Center
  • Svezia
      • Lund, Svezia
        • Skåne University Hospital
      • Stockholm, Svezia
        • Karolinska University Hospital Huddinge
      • Uppsala, Svezia
        • Akademiska sjukhuset Uppsala University Hospital

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Main Inclusion Criteria - Escalation Part (recruitment completed)

  • Documented CD20+ mature B-cell neoplasm

    1. DLBCL - de novo or transformed
    2. HGBCL
    3. PMBCL
    4. FL
    5. MCL
    6. SLL
    7. MZL (nodal, extranodal or mucosa associated)

  • Relapsed 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.

  • Eastern Cooperative Oncology Group (ECOG) performance status 0,1 or 2.

  • Participants must have measurable disease by computed tomography (CT), magnetic resonance imaging (MRI) or Positron emission tomography-Computed tomography (PET-CT) scan

  • Acceptable renal function.

  • Acceptable liver function.

Main Inclusion Criteria - Expansion & Dose-OPT Parts

  • Documented CD20 positive mature B cell neoplasm or CD20+ MCL.
  • DLBCL, de novo or transformed (including double hit or triple hit).
  • PMBCL
  • FL grade 3B
  • Histologic confirmed FL
  • MZL
  • SLL
  • MCL (prior Bruton's tyrosine kinase inhibitor [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 (HSCT) 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.

Main Exclusion Criteria - All Parts

  • Primary central nervous system (CNS) lymphoma or CNS involvement by lymphoma at screening.
  • Known past or current malignancy other than inclusion diagnosis.
  • Aspartate aminotransferase (AST), and/or alanine transaminase (ALT) >3 × upper limit of normal.
  • Total bilirubin >1.5 × upper limit of normal, unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin.
  • Estimated Creatinine clearance (CrCl) <45 milliliters (mL)/min.
  • Known clinically significant cardiovascular disease.
  • Ongoing active bacterial, viral, fungal, mycobacterial, parasitic, or other infection requiring systemic treatment (excluding prophylactic treatment). Past coronavirus disease 2019 (COVID-19) infection may be a risk factor.
  • Confirmed history or current autoimmune disease or other diseases resulting in permanent immunosuppression or requiring permanent immunosuppressive therapy.
  • Seizure disorder requiring therapy (such as steroids or anti-epileptics).
  • Any prior therapy with an investigational bispecific antibody targeting CD3 and CD20.
  • Prior treatment with chimeric antigen receptor T-cell (CAR-T) therapy within 30 days prior to first epcoritamab administration.
  • Eligible for curative intensive salvage therapy followed by high dose chemotherapy with HSCT rescue.
  • Autologous HSCT within 100 days prior to first epcoritamab administration, or any prior allogeneic HSCT or solid organ transplantation.
  • Active hepatitis B (deoxyribonucleic acid [DNA] polymerase chain reaction [PCR]-positive) or hepatitis C (ribonucleic acid [RNA] PCR-positive infection). Participants with evidence of prior hepatitis B (HBV) but who are PCR-negative are permitted in
  • Known human immunodeficiency virus (HIV) infection.
  • Exposed to live or live attenuated vaccine within 4 weeks prior to signing Informed consent form (ICF).
  • Pregnancy or breast feeding.
  • Participant is known or suspected of not being able to comply with the study protocol or has any condition for which, participation would not be in the best interest of the participant.
  • Contraindication to all uric acid lowering agents.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione sequenziale
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Epcoritamab

Epcoritamab will be administered by subcutaneous injections in cycles of 28 days.
Biologico: Epcoritamab

Administered as specified in the treatment arm.

Altri nomi:
  • GEN3013
  • DuoBody®-CD3xCD20
  • EPKINLY®

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Dose-Escalation: Dose Limiting Toxicity (DLT)
Lasso di tempo: During the first cycle (28 days)

To determine the MTD and/or RP2D to be studied in the Expansion part. DLT will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0.
During the first cycle (28 days)
Dose-Escalation: Number of Participants with Adverse Events (AEs)
Lasso di tempo: From first dose until the end of the safety follow-up period (Up to 1 year)

An AE is any untoward medical occurrence in a clinical trial participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product.
From first dose until the end of the safety follow-up period (Up to 1 year)
Expansion: Overall Response Rate (ORR)
Lasso di tempo: Up to 1.5 years

ORR is defined as the percentage of participants achieving complete response (CR) or partial response (PR) based on Lugano criteria.
Up to 1.5 years
Dose-OPT DLBCL, FL and MCL: Percentage of Participants with =>Grade 2 Cytokine Release Syndrome (CRS) Events and All Grade CRS Events
Lasso di tempo: From first dose until 7 days after second full dose (Day 28 for DLBCL; Day 35 for FL; Day 28-35 for MCL)

CRS will be graded based on American Society for Transplantation and Cellular Therapy (ASTCT) criteria.
From first dose until 7 days after second full dose (Day 28 for DLBCL; Day 35 for FL; Day 28-35 for MCL)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Dose-escalation e dose-opt dlbcl, fl e mcl: valori pre-dose di epcoritamab
Lasso di tempo: Predoso e postdosio a più timepoint di ciascun ciclo (lunghezza del ciclo = 28 giorni), fino a circa 1,5 anni
Predoso e postdosio a più timepoint di ciascun ciclo (lunghezza del ciclo = 28 giorni), fino a circa 1,5 anni
Tutte le parti: clearance del corpo totale di epcoritamab dal plasma (CL)
Lasso di tempo: Previsione e postdosio a più calette di ciascun ciclo (lunghezza del ciclo = 28 giorni), dose-escalation: fino a 1 anno; Espansione e dose-opt Parte: fino a 1,5 anni
Previsione e postdosio a più calette di ciascun ciclo (lunghezza del ciclo = 28 giorni), dose-escalation: fino a 1 anno; Espansione e dose-opt Parte: fino a 1,5 anni
Tutte le parti: area sotto curva (AUC) di Epcoritamab
Lasso di tempo: Previsione e postdosio a più calette di ciascun ciclo (lunghezza del ciclo = 28 giorni), dose-escalation: fino a 1 anno; Espansione e dose-opt Parte: fino a 1,5 anni
Previsione e postdosio a più calette di ciascun ciclo (lunghezza del ciclo = 28 giorni), dose-escalation: fino a 1 anno; Espansione e dose-opt Parte: fino a 1,5 anni
Tutte le parti: concentrazione plasmatica massima (di picco) (CMAX) di Epcoritamab
Lasso di tempo: Previsione e postdosio a più calette di ciascun ciclo (lunghezza del ciclo = 28 giorni), dose-escalation: fino a 1 anno; Espansione e dose-opt Parte: fino a 1,5 anni
Previsione e postdosio a più calette di ciascun ciclo (lunghezza del ciclo = 28 giorni), dose-escalation: fino a 1 anno; Espansione e dose-opt Parte: fino a 1,5 anni
Tutte le parti: tempo per raggiungere CMAX di Epcoritamab
Lasso di tempo: Previsione e postdosio a più calette di ciascun ciclo (lunghezza del ciclo = 28 giorni), dose-escalation: fino a 1 anno; Espansione e dose-opt Parte: fino a 1,5 anni
Previsione e postdosio a più calette di ciascun ciclo (lunghezza del ciclo = 28 giorni), dose-escalation: fino a 1 anno; Espansione e dose-opt Parte: fino a 1,5 anni
Tutte le parti: metà vita di epcoritamab (T1/2)
Lasso di tempo: Previsione e postdosio a più calette di ciascun ciclo (lunghezza del ciclo = 28 giorni), dose-escalation: fino a 1 anno; Espansione e dose-opt Parte: fino a 1,5 anni
Previsione e postdosio a più calette di ciascun ciclo (lunghezza del ciclo = 28 giorni), dose-escalation: fino a 1 anno; Espansione e dose-opt Parte: fino a 1,5 anni
Espansione: concentrazione di depressione di Epcoritamab
Lasso di tempo: Fino a 1,5 anni
Fino a 1,5 anni
Dose-Escalation: Number of Participants with Anti-lymphoma Activity of Epcoritamab
Lasso di tempo: Up to 1 year

Anti-lymphoma activity will be evaluated as number of participants with resolution of constitutional symptoms, reduction in tumor size, objective, and best response (ORR, CR and PR).
Up to 1 year
Dose-Escalation: Duration of Response (DOR)
Lasso di tempo: Up to 1 year

DOR is defined as the time from the first documentation of response (CR or PR) to the date of progressive disease (PD) or death, whichever occurs earlier as assessed by the investigator.
Up to 1 year
Expansion: DOR
Lasso di tempo: Up to 1.5 years

DOR is defined as the time from the first documentation of response (CR or PR) to the date of PD or death, whichever occurs earlier based on Lugano criteria.
Up to 1.5 years
Expansion Part: Changes in Lymphoma Symptoms as Measured by the Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym)
Lasso di tempo: Up to 1.5 year

Change from baseline in health-related quality of life over time and in relation to treatment will be evaluated using FACT-Lym scale.
Up to 1.5 year
Dose-OPT DLBCL and FL: Percentage of Participants with >=Grade 2 CRS Events and All Grade CRS Events Following First Full Dose
Lasso di tempo: Up to 1.5 years

CRS will be graded based on ASTCT criteria.
Up to 1.5 years
Dose-OPT DLBCL and FL: Percentage of Participants with >=Grade 2 CRS Events and All Grade CRS Events Overall
Lasso di tempo: Up to 1.5 years

CRS will be graded based on ASTCT criteria.
Up to 1.5 years
Dose-OPT DLBCL and FL: ORR
Lasso di tempo: Up to 1.5 years

ORR is defined as the percentage of participants achieving CR or PR assessed by investigator.
Up to 1.5 years
Dose-OPT DLBCL and FL: CR Rate
Lasso di tempo: Up to 1.5 years

CR rate is defined as the percentage of participants with CR assessed by investigator.
Up to 1.5 years
Dose-OPT DLBCL and FL: Duration of CR (DoCR)
Lasso di tempo: Up to 1.5 years

DoCR is defined as the time from the first documentation of CR to the date of PD or death, whichever occurs earlier assessed by investigator.
Up to 1.5 years
Dose-OPT DLBCL and FL: Progression-Free Survival (PFS)
Lasso di tempo: Up to 1.5 years

PFS is defined as the time from Day 1 of Cycle 1 to first documented PD or death due to any cause, whichever occurs earlier assessed by investigator.
Up to 1.5 years
Dose-OPT DLBCL and FL: DLT
Lasso di tempo: During the first cycle (28 days) in each Dose-OPT Part (DLBCL, FL and MCL)

To determine the MTD and/or RP2D to be studied in the expansion part. DLT will be graded according to NCI-CTCAE version 5.0.
During the first cycle (28 days) in each Dose-OPT Part (DLBCL, FL and MCL)
Dose-OPT DLBCL, FL and MCL: DOR
Lasso di tempo: Up to 1.5 years

DOR is defined as the time from the first documentation of response (CR or PR) to the date of PD or death, whichever occurs earlier based on Lugano criteria assessed by investigator.
Up to 1.5 years
Dose-Escalation, Expansion Part and Dose-OPT MCL: PFS
Lasso di tempo: Dose-Escalation: Up to 1 year; Expansion and Dose-OPT Part (MCL): 1.5 years

PFS is defined as the time from Day 1 of Cycle 1 to first documented PD or death due to any cause, whichever occurs earlier based on Lugano criteria.
Dose-Escalation: Up to 1 year; Expansion and Dose-OPT Part (MCL): 1.5 years
Expansion and Dose-OPT MCL: CR Rate
Lasso di tempo: Up to 1.5 years

CR rate is defined as the percentage of participants with CR based on Lugano criteria.
Up to 1.5 years
Expansion and Dose-OPT MCL: DoCR
Lasso di tempo: Up to 1.5 years

DoCR is defined as the time from the first documentation of CR to the date of PD or death, whichever occurs earlier based on Lugano criteria.
Up to 1.5 years
Expansion and Dose-OPT MCL: ORR
Lasso di tempo: Up to 1.5 years

ORR is defined as the percentage of participants achieving CR or PR based on LYRIC.
Up to 1.5 years
Expansion: Time to Response (TTR)
Lasso di tempo: Up to 1.5 years

TTR is defined as the time from Day 1 of Cycle 1 to first documentation of objective tumor response (PR or better) earlier based on Lugano criteria.
Up to 1.5 years
Expansion and Dose-OPT MCL: CR Rate
Lasso di tempo: Up to 1.5 years

CR rate is defined as the percentage of participants with CR based on LYRIC.
Up to 1.5 years
Expansion and Dose-OPT MCL: PFS
Lasso di tempo: Up to 1.5 years

PFS is defined as the time from Day 1 of Cycle 1 to first documented PD or death due to any cause, whichever occurs earlier based on LYRIC.
Up to 1.5 years
Expansion and Dose-OPT MCL: DOR
Lasso di tempo: Up to 1.5 years

DOR is defined as the time from the first documentation of response (CR or PR) to the date of PD or death, whichever occurs earlier based on LYRIC.
Up to 1.5 years
Expansion and Dose-OPT MCL: DoCR
Lasso di tempo: Up to 1.5 years

DoCR is defined as the time from the first documentation of CR to the date of PD or death, whichever occurs earlier based on LYRIC.
Up to 1.5 years
Expansion and Dose-OPT: TTR
Lasso di tempo: Up to 1.5 years

TTR is defined as the time from Day 1 of Cycle 1 to first documentation of objective tumor response (PR or better) earlier based on LYRIC.
Up to 1.5 years
Expansion and Dose-OPT DLBCL, FL and MCL: Number of Participants with AEs
Lasso di tempo: Up to 7 years and 6 months

An AE is any untoward medical occurrence in a clinical trial participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product.
Up to 7 years and 6 months
Expansion and Dose-OPT DLBCL, FL and MCL: Rate of Minimal Residual Disease (MRD) Negativity
Lasso di tempo: Up to 1.5 years

MRD is defined as percentage of participants with at least 1 MRD negative result.
Up to 1.5 years
All Parts: Number of Participants with CRS Events
Lasso di tempo: Up to Day 1 of Cycle 12 (Cycle length=28 days)

CRS will be graded based on ASTCT criteria.
Up to Day 1 of Cycle 12 (Cycle length=28 days)
All Parts: Number of Participants with Anti-drug Antibody (ADA)
Lasso di tempo: Up to 7 years and 6 months

Plasma samples will be screened for antibodies binding to epcoritamab, and for confirmed positive samples, the titer against the two specific arms of epcoritamab will be reported.
Up to 7 years and 6 months
All Parts: Time to Next Anti-lymphoma Therapy (TTNT)
Lasso di tempo: Dose-Escalation: Up to 1 year; Expansion and Dose-OPT Part (DLBCL, FL and MCL): Up to 1.5 years

TTNT is defined as the time from Day 1 of Cycle 1 to first recorded administration of subsequent anti-lymphoma therapy or death due to any cause, whichever occurs earlier.
Dose-Escalation: Up to 1 year; Expansion and Dose-OPT Part (DLBCL, FL and MCL): Up to 1.5 years
All Parts: Overall survival (OS)
Lasso di tempo: Dose-Escalation: Up to 1 year; Expansion and Dose-OPT Part DLBCL, FL and MCL: Up to 1.5 years

OS is defined as the time from Day 1 of Cycle 1 to death.
Dose-Escalation: Up to 1 year; Expansion and Dose-OPT Part DLBCL, FL and MCL: Up to 1.5 years

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Genmab

Collaboratori

AbbVie

Investigatori

  • Direttore dello studio: Study Official, Genmab

Pubblicazioni e link utili

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Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

26 giugno 2018

Completamento primario (Stimato)

1 gennaio 2029

Completamento dello studio (Stimato)

1 gennaio 2029

Date di iscrizione allo studio

Primo inviato

7 giugno 2018

Primo inviato che soddisfa i criteri di controllo qualità

9 agosto 2018

Primo Inserito (Effettivo)

10 agosto 2018

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

4 novembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

2 novembre 2026

Ultimo verificato

1 ottobre 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • GCT3013-01
  • 2017-001748-36 (Numero EudraCT)
  • 2017 (Sovvenzione/contratto NIH degli Stati Uniti)
  • NL64317.078.17 (Identificatore di registro: CCMO)
  • 241053 (Altro identificatore: IRAS ID; UK Research Summaries Database)
  • 2023 (Sovvenzione/contratto NIH degli Stati Uniti)
  • 2023-504802-12-00 (Ctis)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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