GEN3013, ensayo de epcoritamab en pacientes con linfoma de células B en recaída, progresivo o refractario EPCORE™ NHL-1 (EPCORE™ NHL-1)
Un ensayo de seguridad abierto de fase 1/2 de GEN3013 en pacientes con linfoma de células B en recaída, progresivo o refractario 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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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 de estudio
Inscripción (Actual)
Fase
- Fase 2
- Fase 1
Acceso ampliado
Contactos y Ubicaciones
Ubicaciones de estudio
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Berlin, Alemania
- Charite - Universitaetsmedizin Berlin
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Berlin, Alemania
- Klinik fur Innere Medizin Hamatologie and Onkologie
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Cologne, Alemania
- Universitaetsklinikum Koeln
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Essen, Alemania
- Universitaetsklinikum Essen
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Mainz, Alemania
- Johannes Gutenberg University
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München, Alemania
- Der Universität Munchen Medizinische Klinik III LMU
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Clayton, Australia
- Monash Health
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Concord, Australia
- Concord Hospital
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Fitzroy, Australia
- St. Vincent Hospital
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Herston, Australia
- Royal Brisbane and Women's Hospital
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Hobart, Australia
- Royal Hobart Hospital RHH
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Kogarah, Australia
- St. George Hospital
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Malvern, Australia
- Cabrini Hospital
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Nedlands, Australia
- Sir Charles Gairdner Hospital
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Southport, Australia
- Gold Coast Hospital
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Sydney, Australia
- Westmead Hospital
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Calgary, Canadá
- Tom Baker Cancer Care
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Toronto, Canadá
- Toronto-Sunnybrook Regional Cancer Ctr
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Busan, Corea del Sur
- Dong-A University Hospital
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Daegu, Corea del Sur
- Keimyung University Dongsan Medical Center
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Goyang-si, Corea del Sur
- National Cancer Center
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Jeonju, Corea del Sur
- Chonbuk National University Hospital
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Seongnam-si, Corea del Sur
- Seoul National University Bundang Hospital
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Seoul, Corea del Sur
- Asan Medical Center
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Seoul, Corea del Sur
- Samsung Medical Center
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Seoul, Corea del Sur
- Seoul National University Hospital
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Seoul, Corea del Sur
- Severance Hospital, Yonsei University
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Copenhagen, Dinamarca
- Rigshospitalet
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Odense, Dinamarca, 5000 C
- Odense University Hospital
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Vejle, Dinamarca
- Vejle Hospital
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Badalona, España
- Hospital Germans Trias i Pujol
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Barcelona, España
- Institut Catala de Oncologia
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Barcelona, España
- Hospital Universitario Vall dHebron
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Madrid, España
- Hospital Universitario Fundacin Jimnez Daz
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Navarre
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Pamplona, Navarre, España, 31008
- Clinica Universidad de Navarra
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Arizona
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Phoenix, Arizona, Estados Unidos, 85054
- Arizona Mayo Clinic
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California
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San Francisco, California, Estados Unidos, 94117
- University of California at San Francisco
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Colorado
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Denver, Colorado, Estados Unidos, 80218
- Colorado Blood Cancer Institute
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Florida
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Tampa, Florida, Estados Unidos, 33612
- H. Lee Moffitt Cancer Center and Research Institute
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Iowa
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Iowa City, Iowa, Estados Unidos, 52242
- University of Iowa Hospital and Clinics
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Louisiana
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New Orleans, Louisiana, Estados Unidos, 70121
- Ochsner Medical Center
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Michigan
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Ann Arbor, Michigan, Estados Unidos, 48109
- University of Michigan
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Detroit, Michigan, Estados Unidos, 48334
- Barbara Ann Karmanos Cancer Institute
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Nebraska
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Omaha, Nebraska, Estados Unidos, 68198
- University of Nebraska Medical Center
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New Jersey
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Hackensack, New Jersey, Estados Unidos, 07601
- Hackensack Meridian Health
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Ohio
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Cleveland, Ohio, Estados Unidos, 44195
- The Cleveland Clinic Foundation
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Oregon
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Portland, Oregon, Estados Unidos, 97210
- OHSU Knight Cancer Institute
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Pennsylvania
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Pittsburgh, Pennsylvania, Estados Unidos, 15232
- Hillman Cancer Center
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Rhode Island
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Providence, Rhode Island, Estados Unidos, 02903
- Rhode Island Hospital
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South Carolina
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Charleston, South Carolina, Estados Unidos, 29425
- Medical University of South Carolina
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Texas
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Dallas, Texas, Estados Unidos, 75390
- UT Southwestern
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Houston, Texas, Estados Unidos, 77030
- MD Anderson Cancer Center
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Helsinki, Finlandia
- Helsinki University Hospital
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Kuopio, Finlandia
- Kuopio University Hospital
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Tampere, Finlandia
- Tampere University Hospital
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Créteil, Francia
- Hopital Henri Mondor
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Montpellier, Francia
- CHU Montpellier
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Paris, Francia
- Hospital Saint-Louis
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Pierre-Bénite, Francia
- Hospices Civils de Lyon Centre Hospitalier Lyon Sud
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Rouen, Francia
- Centre Henri Becquerel
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Tours, Francia
- CHU de Tours-Hopital Bretonneau
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Alessandria, Italia
- Ao Ss Antonio E Biagio Alessandria
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Bologna, Italia
- Policlinico S. Orsola-Ematologia LA Seragnoli
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Candiolo, Italia
- Istituto di Candiolo- Fondazione del Piemonte per l'Oncologia
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Meldola, Italia
- Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
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Milan, Italia
- IRCCS Ospedale San Raffaele
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Amsterdam, Países Bajos
- VU University Medical Center
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Maastricht, Países Bajos, 6229 HX
- Maastricht University Medical Center
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Rotterdam, Países Bajos
- Erasmus MC Cancer Institute
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Utrecht, Países Bajos
- Universitair Medisch Centrum Utrecht
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Bydgoszcz, Polonia
- Szpital Uniwersytecki nr 2 im dr. Jana Biziela
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Gdansk, Polonia
- Uniwersyteckie Centrum Kliniczne
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Krakow, Polonia
- Pratia-McM
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Słupsk, Polonia
- Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka
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Warsaw, Polonia
- Maria Sklodowska-Curie Memorial Cancer Center and Institute
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Wroclaw, Polonia
- Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego
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Manchester, Reino Unido
- The Christie NHS Foundation Trust
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Plymouth, Reino Unido
- Plymouth University School of Medicine- Derriford Hospital
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Southampton, Reino Unido
- University Hospital Southampton NHS Foundation Trust
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Sutton, Reino Unido
- Royal Marsden NHS Foundation Trust
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Singapore, Singapur
- National University Hospital
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Singapore, Singapur
- Singapore General Hospital
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Lund, Suecia
- Skåne University Hospital
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Stockholm, Suecia
- Karolinska University Hospital Huddinge
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Uppsala, Suecia
- Akademiska sjukhuset Uppsala University Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Main Inclusion Criteria - Escalation Part (recruitment completed)
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Documented CD20+ mature B-cell neoplasm
- DLBCL - de novo or transformed
- HGBCL
- PMBCL
- FL
- MCL
- SLL
- MZL (nodal, extranodal or mucosa associated)
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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.
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Eastern Cooperative Oncology Group (ECOG) performance status 0,1 or 2.
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Participants must have measurable disease by computed tomography (CT), magnetic resonance imaging (MRI) or Positron emission tomography-Computed tomography (PET-CT) scan
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Acceptable renal function.
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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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación Secuencial
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Epcoritamab
Epcoritamab will be administered by subcutaneous injections in cycles of 28 days. |
Administered as specified in the treatment arm.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Dose-Escalation: Dose Limiting Toxicity (DLT)
Periodo de tiempo: During the first cycle (28 days)
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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)
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Dose-Escalation: Number of Participants with Adverse Events (AEs)
Periodo de tiempo: From first dose until the end of the safety follow-up period (Up to 1 year)
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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)
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Expansion: Overall Response Rate (ORR)
Periodo de tiempo: Up to 1.5 years
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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
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Dose-OPT DLBCL, FL and MCL: Percentage of Participants with =>Grade 2 Cytokine Release Syndrome (CRS) Events and All Grade CRS Events
Periodo de tiempo: From first dose until 7 days after second full dose (Day 28 for DLBCL; Day 35 for FL; Day 28-35 for MCL)
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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)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Escalación de dosis y dosis-opt DLBCL, FL y MCL: Valores de dosis de dosis de Epcoritamab
Periodo de tiempo: Predose y post dosis en múltiples puntos de tiempo de cada ciclo (duración del ciclo = 28 días), hasta aproximadamente 1,5 años
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Predose y post dosis en múltiples puntos de tiempo de cada ciclo (duración del ciclo = 28 días), hasta aproximadamente 1,5 años
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Todas las partes: Liquidación total del cuerpo de Epcoritamab del plasma (CL)
Periodo de tiempo: Predose y post dosis en múltiples puntos de tiempo de cada ciclo (duración del ciclo = 28 días), escala de dosis: hasta 1 año; Parte de expansión y opt de dosis: hasta 1.5 años
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Predose y post dosis en múltiples puntos de tiempo de cada ciclo (duración del ciclo = 28 días), escala de dosis: hasta 1 año; Parte de expansión y opt de dosis: hasta 1.5 años
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Todas las piezas: área bajo curva (AUC) de Epcoritamab
Periodo de tiempo: Predose y post dosis en múltiples puntos de tiempo de cada ciclo (duración del ciclo = 28 días), escala de dosis: hasta 1 año; Parte de expansión y opt de dosis: hasta 1.5 años
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Predose y post dosis en múltiples puntos de tiempo de cada ciclo (duración del ciclo = 28 días), escala de dosis: hasta 1 año; Parte de expansión y opt de dosis: hasta 1.5 años
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Todas las partes: concentración plasmática máxima (pico) (CMAX) de epcoritamab
Periodo de tiempo: Predose y post dosis en múltiples puntos de tiempo de cada ciclo (duración del ciclo = 28 días), escala de dosis: hasta 1 año; Parte de expansión y opt de dosis: hasta 1.5 años
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Predose y post dosis en múltiples puntos de tiempo de cada ciclo (duración del ciclo = 28 días), escala de dosis: hasta 1 año; Parte de expansión y opt de dosis: hasta 1.5 años
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Todas las partes: hora de llegar a CMAX de Epcoritamab
Periodo de tiempo: Predose y post dosis en múltiples puntos de tiempo de cada ciclo (duración del ciclo = 28 días), escala de dosis: hasta 1 año; Parte de expansión y opt de dosis: hasta 1.5 años
|
Predose y post dosis en múltiples puntos de tiempo de cada ciclo (duración del ciclo = 28 días), escala de dosis: hasta 1 año; Parte de expansión y opt de dosis: hasta 1.5 años
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Todas las partes: Half Life of Epcoritamab (T1/2)
Periodo de tiempo: Predose y post dosis en múltiples puntos de tiempo de cada ciclo (duración del ciclo = 28 días), escala de dosis: hasta 1 año; Parte de expansión y opt de dosis: hasta 1.5 años
|
Predose y post dosis en múltiples puntos de tiempo de cada ciclo (duración del ciclo = 28 días), escala de dosis: hasta 1 año; Parte de expansión y opt de dosis: hasta 1.5 años
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Expansión: concentración mínima de epcoritamab
Periodo de tiempo: Hasta 1.5 años
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Hasta 1.5 años
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Dose-Escalation: Number of Participants with Anti-lymphoma Activity of Epcoritamab
Periodo de tiempo: Up to 1 year
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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
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Dose-Escalation: Duration of Response (DOR)
Periodo de tiempo: Up to 1 year
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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
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Expansion: DOR
Periodo de tiempo: Up to 1.5 years
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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
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Expansion Part: Changes in Lymphoma Symptoms as Measured by the Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym)
Periodo de tiempo: Up to 1.5 year
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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
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Dose-OPT DLBCL and FL: Percentage of Participants with >=Grade 2 CRS Events and All Grade CRS Events Following First Full Dose
Periodo de tiempo: Up to 1.5 years
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CRS will be graded based on ASTCT criteria. |
Up to 1.5 years
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Dose-OPT DLBCL and FL: Percentage of Participants with >=Grade 2 CRS Events and All Grade CRS Events Overall
Periodo de tiempo: Up to 1.5 years
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CRS will be graded based on ASTCT criteria. |
Up to 1.5 years
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Dose-OPT DLBCL and FL: ORR
Periodo de tiempo: Up to 1.5 years
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ORR is defined as the percentage of participants achieving CR or PR assessed by investigator. |
Up to 1.5 years
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Dose-OPT DLBCL and FL: CR Rate
Periodo de tiempo: Up to 1.5 years
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CR rate is defined as the percentage of participants with CR assessed by investigator. |
Up to 1.5 years
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Dose-OPT DLBCL and FL: Duration of CR (DoCR)
Periodo de tiempo: Up to 1.5 years
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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
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Dose-OPT DLBCL and FL: Progression-Free Survival (PFS)
Periodo de tiempo: Up to 1.5 years
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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
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Dose-OPT DLBCL and FL: DLT
Periodo de tiempo: During the first cycle (28 days) in each Dose-OPT Part (DLBCL, FL and MCL)
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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)
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Dose-OPT DLBCL, FL and MCL: DOR
Periodo de tiempo: Up to 1.5 years
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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
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Dose-Escalation, Expansion Part and Dose-OPT MCL: PFS
Periodo de tiempo: Dose-Escalation: Up to 1 year; Expansion and Dose-OPT Part (MCL): 1.5 years
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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
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Expansion and Dose-OPT MCL: CR Rate
Periodo de tiempo: Up to 1.5 years
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CR rate is defined as the percentage of participants with CR based on Lugano criteria. |
Up to 1.5 years
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Expansion and Dose-OPT MCL: DoCR
Periodo de tiempo: Up to 1.5 years
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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
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Expansion and Dose-OPT MCL: ORR
Periodo de tiempo: Up to 1.5 years
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ORR is defined as the percentage of participants achieving CR or PR based on LYRIC. |
Up to 1.5 years
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Expansion: Time to Response (TTR)
Periodo de tiempo: Up to 1.5 years
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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
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Expansion and Dose-OPT MCL: CR Rate
Periodo de tiempo: Up to 1.5 years
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CR rate is defined as the percentage of participants with CR based on LYRIC. |
Up to 1.5 years
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Expansion and Dose-OPT MCL: PFS
Periodo de tiempo: Up to 1.5 years
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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
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Expansion and Dose-OPT MCL: DOR
Periodo de tiempo: Up to 1.5 years
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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
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Expansion and Dose-OPT MCL: DoCR
Periodo de tiempo: Up to 1.5 years
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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
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Expansion and Dose-OPT: TTR
Periodo de tiempo: Up to 1.5 years
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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
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Expansion and Dose-OPT DLBCL, FL and MCL: Number of Participants with AEs
Periodo de tiempo: Up to 7 years and 6 months
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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
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Expansion and Dose-OPT DLBCL, FL and MCL: Rate of Minimal Residual Disease (MRD) Negativity
Periodo de tiempo: Up to 1.5 years
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MRD is defined as percentage of participants with at least 1 MRD negative result. |
Up to 1.5 years
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All Parts: Number of Participants with CRS Events
Periodo de tiempo: Up to Day 1 of Cycle 12 (Cycle length=28 days)
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CRS will be graded based on ASTCT criteria. |
Up to Day 1 of Cycle 12 (Cycle length=28 days)
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All Parts: Number of Participants with Anti-drug Antibody (ADA)
Periodo de tiempo: Up to 7 years and 6 months
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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
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All Parts: Time to Next Anti-lymphoma Therapy (TTNT)
Periodo de tiempo: Dose-Escalation: Up to 1 year; Expansion and Dose-OPT Part (DLBCL, FL and MCL): Up to 1.5 years
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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
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All Parts: Overall survival (OS)
Periodo de tiempo: Dose-Escalation: Up to 1 year; Expansion and Dose-OPT Part DLBCL, FL and MCL: Up to 1.5 years
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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
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Colaboradores e Investigadores
Publicaciones y enlaces útiles
Publicaciones Generales
- Hutchings M, Mous R, Clausen MR, Johnson P, Linton KM, Chamuleau MED, Lewis DJ, Sureda Balari A, Cunningham D, Oliveri RS, Elliott B, DeMarco D, Azaryan A, Chiu C, Li T, Chen KM, Ahmadi T, Lugtenburg PJ. Dose escalation of subcutaneous epcoritamab in patients with relapsed or refractory B-cell non-Hodgkin lymphoma: an open-label, phase 1/2 study. Lancet. 2021 Sep 25;398(10306):1157-1169. doi: 10.1016/S0140-6736(21)00889-8. Epub 2021 Sep 8.
- Thieblemont C, Phillips T, Ghesquieres H, Cheah CY, Clausen MR, Cunningham D, Do YR, Feldman T, Gasiorowski R, Jurczak W, Kim TM, Lewis DJ, van der Poel M, Poon ML, Cota Stirner M, Kilavuz N, Chiu C, Chen M, Sacchi M, Elliott B, Ahmadi T, Hutchings M, Lugtenburg PJ. Epcoritamab, a Novel, Subcutaneous CD3xCD20 Bispecific T-Cell-Engaging Antibody, in Relapsed or Refractory Large B-Cell Lymphoma: Dose Expansion in a Phase I/II Trial. J Clin Oncol. 2023 Apr 20;41(12):2238-2247. doi: 10.1200/JCO.22.01725. Epub 2022 Dec 22.
- Linton KM, Vitolo U, Jurczak W, Lugtenburg PJ, Gyan E, Sureda A, Christensen JH, Hess B, Tilly H, Cordoba R, Lewis DJ, Okada C, Hutchings M, Clausen MR, Sancho JM, Cochrane T, Leppa S, Chamuleau MED, Gernhardt D, Altintas I, Liu Y, Ahmadi T, Dinh MH, Hoehn D, Favaro E, Elliott B, Thieblemont C, Vose JM. Epcoritamab monotherapy in patients with relapsed or refractory follicular lymphoma (EPCORE NHL-1): a phase 2 cohort of a single-arm, multicentre study. Lancet Haematol. 2024 Aug;11(8):e593-e605. doi: 10.1016/S2352-3026(24)00166-2. Epub 2024 Jun 15.
- Danilov AV, Kambhampati Thiruvengadam S, Linton K, Cumings K, Chirikov V, Mutebi A, Bains Chawla S, Chhibber A, Rivas Navarro F, Marques Goncalves F, Wang A, Ding Z, Alshreef A, Favaro E, Hoehn D, Sureda A. Indirect comparison of epcoritamab vs chemoimmunotherapy, mosunetuzumab, or odronextamab in follicular lymphoma. Blood Adv. 2025 Aug 12;9(15):3754-3765. doi: 10.1182/bloodadvances.2024015274.
- Thieblemont C, Karimi YH, Ghesquieres H, Cheah CY, Clausen MR, Cunningham D, Jurczak W, Do YR, Gasiorowski R, Lewis DJ, Kim TM, van der Poel M, Poon ML, Feldman T, Linton KM, Sureda A, Hutchings M, Dinh MH, Kilavuz N, Soong D, Mark T, Sacchi M, Phillips T, Lugtenburg PJ. Epcoritamab in relapsed/refractory large B-cell lymphoma: 2-year follow-up from the pivotal EPCORE NHL-1 trial. Leukemia. 2024 Dec;38(12):2653-2662. doi: 10.1038/s41375-024-02410-8. Epub 2024 Sep 25.
- Phillips T, Lugtenburg P, Kalsekar A, Mutebi A, Wang A, Blaedel J, Kosa K, Martin S, Sacchi M, Kilavuz N, Thieblemont C. Improvements in Patient-Reported Outcomes in Relapsed or Refractory Large B-Cell Lymphoma Patients Treated With Epcoritamab. Clin Lymphoma Myeloma Leuk. 2024 Mar;24(3):e78-e87.e2. doi: 10.1016/j.clml.2023.11.005. Epub 2023 Nov 27.
- Sinnollareddy M, Sanghavi K, Gibiansky L, Li T, Putnins M, Mohamed MF, Patah P, Favaro E, Gupta M, Parikh A, Xu S. Exposure-Response Analyses to Inform the Optimal Epcoritamab Monotherapy Dosing Regimen in Relapsed or Refractory Follicular Lymphoma. Clin Pharmacokinet. 2026 Aug 1. doi: 10.1007/s40262-026-01661-1. Online ahead of print.
- Li T, Tredennick A, Polhamus D, Putnins M, Liu S, Sanghavi K, Thalhauser CJ, Parikh A, Noorani B, Mohamed MF, Le Gallo C, Elliott B, Gupta M, Xu S. Epcoritamab Step-Up Dosing Regimen Selection and Optimization Using Repeated Time-to-Event Modeling for Cytokine Release Syndrome Risk Mitigation. Clin Pharmacol Ther. 2026 Aug;120(2):542-551. doi: 10.1002/cpt.70362. Epub 2026 Jul 7.
- Altintas I, Morehouse C, Favaro E, Rana A, Karavitis J, Szafer-Glusman E, Zhao K, Linton K, Danilov A, LaCasce AS, Falchi L, Okosun J, Ahmadi T, Fereshteh M, Jure-Kunkel M, Soong D, Steele AJ. MRD negativity by PBMCs and ctDNA confirms deep and durable responses after epcoritamab monotherapy in R/R FL. Blood Adv. 2026 Oct 13;10(19):6381-6394. doi: 10.1182/bloodadvances.2025017565.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Procesos Patológicos
- Neoplasias
- Enfermedad crónica
- Atributos de la enfermedad
- Enfermedades del sistema inmunológico
- Neoplasias por tipo histológico
- Enfermedades hematológicas
- Enfermedades linfáticas
- Trastornos linfoproliferativos
- Trastornos inmunoproliferativos
- Linfoma No Hodgkin
- Leucemia de células B
- Linfoma de células B
- Linfoma
- Leucemia Linfoide
- Leucemia
- Condiciones Patológicas, Signos y Síntomas
- Enfermedades hemic y linfáticas
- Leucemia Linfocítica Crónica De Células B
- Linfoma, Células B, Zona Marginal
Otros números de identificación del estudio
- GCT3013-01
- 2017-001748-36 (Número EudraCT)
- 2017 (Subvención/contrato del NIH de EE. UU.)
- NL64317.078.17 (Identificador de registro: CCMO)
- 241053 (Otro identificador: IRAS ID; UK Research Summaries Database)
- 2023 (Subvención/contrato del NIH de EE. UU.)
- 2023-504802-12-00 (Ctis)
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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