GEN3013, Epcoritamab-tutkimus potilailla, joilla on uusiutunut, progressiivinen tai refraktaarinen B-solulymfooma EPCORE™ NHL-1 (EPCORE™ NHL-1)
Vaihe 1/2, avoin turvallisuuskoe GEN3013:sta potilailla, joilla on uusiutunut, progressiivinen tai refraktaarinen B-solulymfooma 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.
Tutkimuksen yleiskatsaus
Tila
Ehdot
Interventio / Hoito
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Ilmoittautuminen (Todellinen)
Vaihe
- Vaihe 2
- Vaihe 1
Laajennettu käyttöoikeus
Yhteystiedot ja paikat
Opiskelupaikat
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Amsterdam, Alankomaat
- VU University Medical Center
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Maastricht, Alankomaat, 6229 HX
- Maastricht University Medical Center
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Rotterdam, Alankomaat
- Erasmus MC Cancer Institute
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Utrecht, Alankomaat
- Universitair Medisch Centrum Utrecht
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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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Badalona, Espanja
- Hospital Germans Trias i Pujol
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Barcelona, Espanja
- Institut Catala de Oncologia
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Barcelona, Espanja
- Hospital Universitario Vall dHebron
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Madrid, Espanja
- Hospital Universitario Fundacin Jimnez Daz
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Navarre
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Pamplona, Navarre, Espanja, 31008
- Clinica Universidad de Navarra
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Busan, Etelä -Korea
- Dong-A University Hospital
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Daegu, Etelä -Korea
- Keimyung University Dongsan Medical Center
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Goyang-si, Etelä -Korea
- National Cancer Center
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Jeonju, Etelä -Korea
- Chonbuk National University Hospital
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Seongnam-si, Etelä -Korea
- Seoul National University Bundang Hospital
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Seoul, Etelä -Korea
- Asan Medical Center
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Seoul, Etelä -Korea
- Samsung Medical Center
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Seoul, Etelä -Korea
- Seoul National University Hospital
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Seoul, Etelä -Korea
- Severance Hospital, Yonsei University
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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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Calgary, Kanada
- Tom Baker Cancer Care
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Toronto, Kanada
- Toronto-Sunnybrook Regional Cancer Ctr
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Bydgoszcz, Puola
- Szpital Uniwersytecki nr 2 im dr. Jana Biziela
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Gdansk, Puola
- Uniwersyteckie Centrum Kliniczne
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Krakow, Puola
- Pratia-McM
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Słupsk, Puola
- Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka
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Warsaw, Puola
- Maria Sklodowska-Curie Memorial Cancer Center and Institute
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Wroclaw, Puola
- Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego
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Créteil, Ranska
- Hopital Henri Mondor
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Montpellier, Ranska
- CHU Montpellier
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Paris, Ranska
- Hospital Saint-Louis
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Pierre-Bénite, Ranska
- Hospices Civils de Lyon Centre Hospitalier Lyon Sud
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Rouen, Ranska
- Centre Henri Becquerel
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Tours, Ranska
- CHU de Tours-Hopital Bretonneau
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Lund, Ruotsi
- Skåne University Hospital
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Stockholm, Ruotsi
- Karolinska University Hospital Huddinge
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Uppsala, Ruotsi
- Akademiska sjukhuset Uppsala University Hospital
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Berlin, Saksa
- Charite - Universitaetsmedizin Berlin
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Berlin, Saksa
- Klinik fur Innere Medizin Hamatologie and Onkologie
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Cologne, Saksa
- Universitaetsklinikum Koeln
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Essen, Saksa
- Universitaetsklinikum Essen
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Mainz, Saksa
- Johannes Gutenberg University
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München, Saksa
- Der Universität Munchen Medizinische Klinik III LMU
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Singapore, Singapore
- National University Hospital
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Singapore, Singapore
- Singapore General Hospital
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Helsinki, Suomi
- Helsinki University Hospital
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Kuopio, Suomi
- Kuopio University Hospital
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Tampere, Suomi
- Tampere University Hospital
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Copenhagen, Tanska
- Rigshospitalet
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Odense, Tanska, 5000 C
- Odense University Hospital
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Vejle, Tanska
- Vejle Hospital
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Manchester, Yhdistynyt kuningaskunta
- The Christie NHS Foundation Trust
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Plymouth, Yhdistynyt kuningaskunta
- Plymouth University School of Medicine- Derriford Hospital
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Southampton, Yhdistynyt kuningaskunta
- University Hospital Southampton NHS Foundation Trust
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Sutton, Yhdistynyt kuningaskunta
- Royal Marsden NHS Foundation Trust
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Arizona
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Phoenix, Arizona, Yhdysvallat, 85054
- Arizona Mayo Clinic
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California
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San Francisco, California, Yhdysvallat, 94117
- University of California at San Francisco
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Colorado
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Denver, Colorado, Yhdysvallat, 80218
- Colorado Blood Cancer Institute
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Florida
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Tampa, Florida, Yhdysvallat, 33612
- H. Lee Moffitt Cancer Center and Research Institute
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Iowa
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Iowa City, Iowa, Yhdysvallat, 52242
- University of Iowa Hospital and Clinics
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Louisiana
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New Orleans, Louisiana, Yhdysvallat, 70121
- Ochsner Medical Center
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Michigan
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Ann Arbor, Michigan, Yhdysvallat, 48109
- University of Michigan
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Detroit, Michigan, Yhdysvallat, 48334
- Barbara Ann Karmanos Cancer Institute
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Nebraska
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Omaha, Nebraska, Yhdysvallat, 68198
- University of Nebraska Medical Center
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New Jersey
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Hackensack, New Jersey, Yhdysvallat, 07601
- Hackensack Meridian Health
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Ohio
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Cleveland, Ohio, Yhdysvallat, 44195
- The Cleveland Clinic Foundation
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Oregon
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Portland, Oregon, Yhdysvallat, 97210
- OHSU Knight Cancer Institute
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Pennsylvania
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Pittsburgh, Pennsylvania, Yhdysvallat, 15232
- Hillman Cancer Center
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Rhode Island
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Providence, Rhode Island, Yhdysvallat, 02903
- Rhode Island Hospital
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South Carolina
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Charleston, South Carolina, Yhdysvallat, 29425
- Medical University of South Carolina
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Texas
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Dallas, Texas, Yhdysvallat, 75390
- UT Southwestern
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Houston, Texas, Yhdysvallat, 77030
- MD Anderson Cancer Center
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
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.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Ei käytössä
- Inventiomalli: Peräkkäinen tehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Kokeellinen: Epcoritamab
Epcoritamab will be administered by subcutaneous injections in cycles of 28 days. |
Administered as specified in the treatment arm.
Muut nimet:
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Dose-Escalation: Dose Limiting Toxicity (DLT)
Aikaikkuna: 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)
Aikaikkuna: 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)
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|
Expansion: Overall Response Rate (ORR)
Aikaikkuna: 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
Aikaikkuna: 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)
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Annos-eskalaatio ja annos-opt DLBCL, FL ja MCL: EpcoritaMabin annosarvot
Aikaikkuna: Ennalta ja postnoose kunkin syklin (syklin pituus = 28 päivää) useissa ajankohdissa, noin 1,5 vuotta
|
Ennalta ja postnoose kunkin syklin (syklin pituus = 28 päivää) useissa ajankohdissa, noin 1,5 vuotta
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Kaikki osat: Epcoritamabin kokonaisryhmä plasmasta (CL)
Aikaikkuna: Ennalta ja postnose kunkin syklin (syklin pituus = 28 päivää), annoseskalaatio: enintään 1 vuosi; Laajennus ja annos-optiosa: enintään 1,5 vuotta
|
Ennalta ja postnose kunkin syklin (syklin pituus = 28 päivää), annoseskalaatio: enintään 1 vuosi; Laajennus ja annos-optiosa: enintään 1,5 vuotta
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Kaikki osat: Epcoritamabin käyrän alla (AUC)
Aikaikkuna: Ennalta ja postnose kunkin syklin (syklin pituus = 28 päivää), annoseskalaatio: enintään 1 vuosi; Laajennus ja annos-optiosa: enintään 1,5 vuotta
|
Ennalta ja postnose kunkin syklin (syklin pituus = 28 päivää), annoseskalaatio: enintään 1 vuosi; Laajennus ja annos-optiosa: enintään 1,5 vuotta
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Kaikki osat: Epcoritamabin maksimiarvo (huippu) plasmapitoisuus (CMAX)
Aikaikkuna: Ennalta ja postnose kunkin syklin (syklin pituus = 28 päivää), annoseskalaatio: enintään 1 vuosi; Laajennus ja annos-optiosa: enintään 1,5 vuotta
|
Ennalta ja postnose kunkin syklin (syklin pituus = 28 päivää), annoseskalaatio: enintään 1 vuosi; Laajennus ja annos-optiosa: enintään 1,5 vuotta
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Kaikki osat: Aika saavuttaa Cmax of Epcoritamab
Aikaikkuna: Ennalta ja postnose kunkin syklin (syklin pituus = 28 päivää), annoseskalaatio: enintään 1 vuosi; Laajennus ja annos-optiosa: enintään 1,5 vuotta
|
Ennalta ja postnose kunkin syklin (syklin pituus = 28 päivää), annoseskalaatio: enintään 1 vuosi; Laajennus ja annos-optiosa: enintään 1,5 vuotta
|
|
|
Kaikki osat: Epcoritamabin puoliaika (T1/2)
Aikaikkuna: Ennalta ja postnose kunkin syklin (syklin pituus = 28 päivää), annoseskalaatio: enintään 1 vuosi; Laajennus ja annos-optiosa: enintään 1,5 vuotta
|
Ennalta ja postnose kunkin syklin (syklin pituus = 28 päivää), annoseskalaatio: enintään 1 vuosi; Laajennus ja annos-optiosa: enintään 1,5 vuotta
|
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Laajennus: Epcoritamabin koteloiden pitoisuus
Aikaikkuna: Enintään 1,5 vuotta
|
Enintään 1,5 vuotta
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Dose-Escalation: Number of Participants with Anti-lymphoma Activity of Epcoritamab
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: Up to 1.5 years
|
CRS will be graded based on ASTCT criteria. |
Up to 1.5 years
|
|
Dose-OPT DLBCL and FL: ORR
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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
|
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Yleiset julkaisut
- 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.
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Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
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Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
- Patologiset prosessit
- Neoplasmat
- Krooninen sairaus
- Sairauden ominaisuudet
- Immuunijärjestelmän sairaudet
- Neoplasmat histologisen tyypin mukaan
- Hematologiset sairaudet
- Lymfaattiset sairaudet
- Lymfoproliferatiiviset häiriöt
- Immunoproliferatiiviset häiriöt
- Lymfooma, non-Hodgkin
- Leukemia, B-solu
- Lymfooma, B-solu
- Lymfooma
- Leukemia, imusolmukkeet
- Leukemia
- Patologiset tilat, merkit ja oireet
- Hemic- ja imusuutteet
- Leukemia, lymfosyyttinen, krooninen, B-solu
- Lymfooma, B-solu, marginaalinen vyöhyke
Muut tutkimustunnusnumerot
- GCT3013-01
- 2017-001748-36 (EudraCT-numero)
- 2017 (Yhdysvaltain NIH-apuraha/sopimus)
- NL64317.078.17 (Rekisterin tunniste: CCMO)
- 241053 (Muu tunniste: IRAS ID; UK Research Summaries Database)
- 2023 (Yhdysvaltain NIH-apuraha/sopimus)
- 2023-504802-12-00 (Ctis)
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