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AzTrials

DLBCLPhase 1/2EPCORE™ NHL-1NCT03625037

First-in-Human (FIH) Trial in Patients With Relapsed, Progressive or Refractory B-Cell Lymphoma

A Phase 1/2 study testing Epcoritamab in people with DLBCL and High-grade B-cell Lymphoma (HGBCL), run by Genmab at 85 sites in 15 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Epcoritamab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
666 participants
Where
85 sitesin 15 countries
Study dates
26 Jun 2018to Jan 2029
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Trial locations and contacts

85 sites in 15 countries.

85 sites in 15 countries

United States17 sites

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • The Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • UT Southwestern

    Dallas, Texas, 75390

  • Colorado Blood Cancer Institute

    Denver, Colorado, 80218

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48334

  • Hackensack Meridian Health

    Hackensack, New Jersey, 07601

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • University of Iowa Hospital and Clinics

    Iowa City, Iowa, 52242

  • Ochsner Medical Center

    New Orleans, Louisiana, 70121

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

  • Arizona Mayo Clinic

    Phoenix, Arizona, 85054

  • Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232

  • OHSU Knight Cancer Institute

    Portland, Oregon, 97210

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • University of California at San Francisco

    San Francisco, California, 94117

  • H. Lee Moffitt Cancer Center and Research Institute

    Tampa, Florida, 33612

Other trials in United States

Australia10 sites

  • Monash Health

    Clayton

  • Concord Hospital

    Concord

  • St. Vincent Hospital

    Fitzroy

  • Royal Brisbane and Women's Hospital

    Herston

  • Royal Hobart Hospital RHH

    Hobart

  • St. George Hospital

    Kogarah

  • Cabrini Hospital

    Malvern

  • Sir Charles Gairdner Hospital

    Nedlands

  • Gold Coast Hospital

    Southport

  • Westmead Hospital

    Sydney

Other trials in Australia

South Korea9 sites

  • Dong-A University Hospital

    Busan

  • Keimyung University Dongsan Medical Center

    Daegu

  • National Cancer Center

    Goyang-si

  • Chonbuk National University Hospital

    Jeonju

  • Seoul National University Bundang Hospital

    Seongnam-si

  • Asan Medical Center

    Seoul

  • Samsung Medical Center

    Seoul

  • Seoul National University Hospital

    Seoul

  • Severance Hospital, Yonsei University

    Seoul

Other trials in South Korea

France6 sites

  • Hopital Henri Mondor

    Créteil

  • CHU Montpellier

    Montpellier

  • Hospital Saint-Louis

    Paris

  • Hospices Civils de Lyon Centre Hospitalier Lyon Sud

    Pierre-Bénite

  • Centre Henri Becquerel

    Rouen

  • CHU de Tours-Hopital Bretonneau

    Tours

Other trials in France

Germany6 sites

  • Charite - Universitaetsmedizin Berlin

    Berlin

  • Klinik fur Innere Medizin Hamatologie and Onkologie

    Berlin

  • Universitaetsklinikum Koeln

    Cologne

  • Universitaetsklinikum Essen

    Essen

  • Johannes Gutenberg University

    Mainz

  • Der Universität Munchen Medizinische Klinik III LMU

    München

Other trials in Germany

Poland6 sites

  • Szpital Uniwersytecki nr 2 im dr. Jana Biziela

    Bydgoszcz

  • Uniwersyteckie Centrum Kliniczne

    Gdansk

  • Pratia-McM

    Krakow

  • Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka

    Słupsk

  • Maria Sklodowska-Curie Memorial Cancer Center and Institute

    Warsaw

  • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego

    Wroclaw

Other trials in Poland

Italy5 sites

  • Ao Ss Antonio E Biagio Alessandria

    Alessandria

  • Policlinico S. Orsola-Ematologia LA Seragnoli

    Bologna

  • Istituto di Candiolo- Fondazione del Piemonte per l'Oncologia

    Candiolo

  • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

    Meldola

  • IRCCS Ospedale San Raffaele

    Milan

Other trials in Italy

Spain5 sites

  • Hospital Germans Trias i Pujol

    Badalona

  • Hospital Universitario Vall dHebron

    Barcelona

  • Institut Catala de Oncologia

    Barcelona

  • Hospital Universitario Fundacin Jimnez Daz

    Madrid

  • Clinica Universidad de Navarra

    Pamplona, Navarre, 31008

Other trials in Spain

Netherlands4 sites

  • VU University Medical Center

    Amsterdam

  • Maastricht University Medical Center

    Maastricht, 6229 HX

  • Erasmus MC Cancer Institute

    Rotterdam

  • Universitair Medisch Centrum Utrecht

    Utrecht

Other trials in Netherlands

United Kingdom4 sites

  • The Christie NHS Foundation Trust

    Manchester

  • Plymouth University School of Medicine- Derriford Hospital

    Plymouth

  • University Hospital Southampton NHS Foundation Trust

    Southampton

  • Royal Marsden NHS Foundation Trust

    Sutton

Other trials in United Kingdom

Denmark3 sites

  • Rigshospitalet

    Copenhagen

  • Odense University Hospital

    Odense, 5000 C

  • Vejle Hospital

    Vejle

Other trials in Denmark

Finland3 sites

  • Helsinki University Hospital

    Helsinki

  • Kuopio University Hospital

    Kuopio

  • Tampere University Hospital

    Tampere

Other trials in Finland

Sweden3 sites

  • Skåne University Hospital

    Lund

  • Karolinska University Hospital Huddinge

    Stockholm

  • Akademiska sjukhuset Uppsala University Hospital

    Uppsala

Other trials in Sweden

Canada2 sites

  • Tom Baker Cancer Care

    Calgary

  • Toronto-Sunnybrook Regional Cancer Ctr

    Toronto

Other trials in Canada

Singapore2 sites

  • National University Hospital

    Singapore

  • Singapore General Hospital

    Singapore

Other trials in Singapore

About this study

Official title: A Phase 1/2, Open-label Safety Trial of GEN3013 in Patients With Relapsed, Progressive or Refractory B-Cell Lymphoma

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
Read more

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.

Read the detailed description

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.

Being tested
Epcoritamab
Medical subject headings
Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, B-Cell, Marginal Zone

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EpcoritamabBiological

    Also called GEN3013, DuoBody®-CD3xCD20, EPKINLY™

    Administered as specified in the treatment arm.

Study groups in NCT03625037
Study groupRoleWhat they receive
EpcoritamabExperimentalEpcoritamab will be administered by subcutaneous injections in cycles of 28 days.
Receives: Biological: Epcoritamab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose-Escalation: Dose Limiting Toxicity (DLT)

    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.

    Measured: During the first cycle (28 days)

  2. Dose-Escalation: Number of Participants with Adverse Events (AEs)

    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.

    Measured: From first dose until the end of the safety follow-up period (Up to 1 year)

  3. Expansion: Overall Response Rate (ORR)

    ORR is defined as the percentage of participants achieving complete response (CR) or partial response (PR) based on Lugano criteria.

    Measured: Up to 1.5 years

  4. Dose-OPT DLBCL, FL and MCL: Percentage of Participants with =>Grade 2 Cytokine Release Syndrome (CRS) Events and All Grade CRS Events

    CRS will be graded based on American Society for Transplantation and Cellular Therapy (ASTCT) criteria.

    Measured: From first dose until 7 days after second full dose (Day 28 for DLBCL; Day 35 for FL; Day 28-35 for MCL)

Secondary outcomes (35)

  1. Dose-Escalation: Number of Participants with Anti-lymphoma Activity of Epcoritamab

    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).

    Measured: Up to 1 year

  2. Dose-Escalation: Duration of Response (DOR)

    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.

    Measured: Up to 1 year

  3. Expansion: DOR

    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.

    Measured: Up to 1.5 years

  4. Expansion Part: Changes in Lymphoma Symptoms as Measured by the Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym)

    Change from baseline in health-related quality of life over time and in relation to treatment will be evaluated using FACT-Lym scale.

    Measured: Up to 1.5 year

  5. Dose-OPT DLBCL and FL: Percentage of Participants with >=Grade 2 CRS Events and All Grade CRS Events Following First Full Dose

    CRS will be graded based on ASTCT criteria.

    Measured: Up to 1.5 years

  6. Dose-OPT DLBCL and FL: Percentage of Participants with >=Grade 2 CRS Events and All Grade CRS Events Overall

    CRS will be graded based on ASTCT criteria.

    Measured: Up to 1.5 years

  7. Dose-OPT DLBCL and FL: ORR

    ORR is defined as the percentage of participants achieving CR or PR assessed by investigator.

    Measured: Up to 1.5 years

  8. Dose-OPT DLBCL and FL: CR Rate

    CR rate is defined as the percentage of participants with CR assessed by investigator.

    Measured: Up to 1.5 years

  9. Dose-OPT DLBCL and FL: Duration of CR (DoCR)

    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.

    Measured: Up to 1.5 years

  10. Dose-OPT DLBCL and FL: Progression-Free Survival (PFS)

    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.

    Measured: Up to 1.5 years

  11. Dose-OPT DLBCL and FL: DLT

    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.

    Measured: During the first cycle (28 days) in each Dose-OPT Part (DLBCL, FL and MCL)

  12. Dose-OPT DLBCL, FL and MCL: DOR

    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.

    Measured: Up to 1.5 years

  13. Dose-Escalation and Dose-OPT DLBCL, FL and MCL: Pre-dose Values of Epcoritamab

    Measured: Predose and postdose at multiple timepoints of each Cycle (Cycle length=28 days), up to approximately 1.5 years

  14. Dose-Escalation, Expansion Part and Dose-OPT MCL: PFS

    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.

    Measured: Dose-Escalation: Up to 1 year; Expansion and Dose-OPT Part (MCL): 1.5 years

  15. Expansion and Dose-OPT MCL: CR Rate

    CR rate is defined as the percentage of participants with CR based on Lugano criteria.

    Measured: Up to 1.5 years

  16. Expansion and Dose-OPT MCL: DoCR

    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.

    Measured: Up to 1.5 years

  17. Expansion and Dose-OPT MCL: ORR

    ORR is defined as the percentage of participants achieving CR or PR based on LYRIC.

    Measured: Up to 1.5 years

  18. Expansion: Time to Response (TTR)

    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.

    Measured: Up to 1.5 years

  19. Expansion and Dose-OPT MCL: CR Rate

    CR rate is defined as the percentage of participants with CR based on LYRIC.

    Measured: Up to 1.5 years

  20. Expansion and Dose-OPT MCL: PFS

    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.

    Measured: Up to 1.5 years

  21. Expansion and Dose-OPT MCL: DOR

    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.

    Measured: Up to 1.5 years

  22. Expansion and Dose-OPT MCL: DoCR

    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.

    Measured: Up to 1.5 years

  23. Expansion and Dose-OPT: TTR

    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.

    Measured: Up to 1.5 years

  24. Expansion and Dose-OPT DLBCL, FL and MCL: Number of Participants with AEs

    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.

    Measured: Up to 7 years and 6 months

  25. Expansion and Dose-OPT DLBCL, FL and MCL: Rate of Minimal Residual Disease (MRD) Negativity

    MRD is defined as percentage of participants with at least 1 MRD negative result.

    Measured: Up to 1.5 years

  26. All Parts: Number of Participants with CRS Events

    CRS will be graded based on ASTCT criteria.

    Measured: Up to Day 1 of Cycle 12 (Cycle length=28 days)

  27. All Parts: Total Body Clearance of Epcoritamab from the Plasma (CL)

    Measured: Predose and postdose at multiple timepoints of each cycle (Cycle length=28 days), Dose-Escalation: Up to 1 year; Expansion and Dose-OPT Part: Up to 1.5 years

  28. All Parts: Area under Curve (AUC) of Epcoritamab

    Measured: Predose and postdose at multiple timepoints of each cycle (Cycle length=28 days), Dose-Escalation: Up to 1 year; Expansion and Dose-OPT Part: Up to 1.5 years

  29. All Parts: Maximum (peak) Plasma Concentration (Cmax) of Epcoritamab

    Measured: Predose and postdose at multiple timepoints of each cycle (Cycle length=28 days), Dose-Escalation: Up to 1 year; Expansion and Dose-OPT Part: Up to 1.5 years

  30. All Parts: Time to Reach Cmax of Epcoritamab

    Measured: Predose and postdose at multiple timepoints of each cycle (Cycle length=28 days), Dose-Escalation: Up to 1 year; Expansion and Dose-OPT Part: Up to 1.5 years

  31. All Parts: Half Life of Epcoritamab (t1/2)

    Measured: Predose and postdose at multiple timepoints of each cycle (Cycle length=28 days), Dose-Escalation: Up to 1 year; Expansion and Dose-OPT Part: Up to 1.5 years

  32. All Parts: Number of Participants with Anti-drug Antibody (ADA)

    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.

    Measured: Up to 7 years and 6 months

  33. All Parts: Time to Next Anti-lymphoma Therapy (TTNT)

    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.

    Measured: Dose-Escalation: Up to 1 year; Expansion and Dose-OPT Part (DLBCL, FL and MCL): Up to 1.5 years

  34. All Parts: Overall survival (OS)

    OS is defined as the time from Day 1 of Cycle 1 to death.

    Measured: Dose-Escalation: Up to 1 year; Expansion and Dose-OPT Part DLBCL, FL and MCL: Up to 1.5 years

  35. Expansion: Trough Concentration of Epcoritamab

    Measured: Up to 1.5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Aug 2018
  2. Study start26 Jun 2018
  3. Primary completionJan 2029 (estimated)
  4. Study completionJan 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
666 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03625037
Sponsor's protocol ID
GCT3013-01
Other IDs
2017-001748-36, NL64317.078.17, 241053, 2023-504802-12-00, 2023, 2017
Acronym
EPCORE™ NHL-1
Status last verified
Oct 2026
First submitted
7 Jun 2018
Last updated
6 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No
Expanded access
Available

Publications

  • 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.

    PubMed 36548927

  • 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.

    PubMed 38889737

  • 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.

    PubMed 42541678

  • 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.

    PubMed 42431612

  • 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.

    PubMed 42411504

  • 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.

    PubMed 40472301

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Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Epcoritamab in people with DLBCL and High-grade B-cell Lymphoma (HGBCL), run by Genmab at 85 sites in 15 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 85 sites in United States, Australia, South Korea, France, Germany and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose-Escalation: Dose Limiting Toxicity (DLT) (time frame: During the first cycle (28 days)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03625037, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.

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EPCORE™ NHL-1 Clinical Trial NCT03625037 | AzTrials