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NCT03625037

PHASE1/PHASE2

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

Sponsor: Genmab

View on ClinicalTrials.gov

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 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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

666

Start Date

2018-06-26

Completion Date

2029-01

Last Updated

2026-04-08

Healthy Volunteers

Conditions

DLBCL High-grade B-cell Lymphoma (HGBCL)Primary Mediastinal Large B-cell Lymphoma (PMBCL)FL MCL Small Lymphocytic Lymphoma (SLL)Marginal Zone Lymphoma (MZL)Indolent B-cell Non-Hodgkin Lymphoma (iNHL)Aggressive B-cell Non-Hodgkin Lymphoma (aNHL)

Interventions

BIOLOGICAL

Epcoritamab

Administered as specified in the treatment arm.

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.

Locations (85)

Arizona Mayo Clinic

Phoenix, Arizona, United States

University of California at San Francisco

San Francisco, California, United States

Colorado Blood Cancer Institute

Denver, Colorado, United States

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, United States

University of Iowa Hospital and Clinics

Iowa City, Iowa, United States

Ochsner Medical Center

New Orleans, Louisiana, United States

University of Michigan

Ann Arbor, Michigan, United States

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

Hackensack Meridian Health

Hackensack, New Jersey, United States

The Cleveland Clinic Foundation

Cleveland, Ohio, United States

OHSU Knight Cancer Institute

Portland, Oregon, United States

Hillman Cancer Center

Pittsburgh, Pennsylvania, United States

Rhode Island Hospital

Providence, Rhode Island, United States

Medical University of South Carolina

Charleston, South Carolina, United States

UT Southwestern

Dallas, Texas, United States

MD Anderson Cancer Center

Houston, Texas, United States

Monash Health

Clayton, Australia

Concord Hospital

Concord, Australia

St. Vincent Hospital

Fitzroy, Australia

Royal Brisbane and Women's Hospital

Herston, Australia

Royal Hobart Hospital RHH

Hobart, Australia

St. George Hospital

Kogarah, Australia

Cabrini Hospital

Malvern, Australia

Sir Charles Gairdner Hospital

Nedlands, Australia

Gold Coast Hospital

Southport, Australia

Westmead Hospital

Sydney, Australia

Tom Baker Cancer Care

Calgary, Canada

Toronto-Sunnybrook Regional Cancer Ctr

Toronto, Canada

Rigshospitalet

Copenhagen, Denmark

Odense University Hospital

Odense, Denmark

Vejle Hospital

Vejle, Denmark

Helsinki University Hospital

Helsinki, Finland

Kuopio University Hospital

Kuopio, Finland

Tampere University Hospital

Tampere, Finland

Hopital Henri Mondor

Créteil, France

CHU Montpellier

Montpellier, France

Hospital Saint-Louis

Paris, France

Hospices Civils de Lyon Centre Hospitalier Lyon Sud

Pierre-Bénite, France

Centre Henri Becquerel

Rouen, France

CHU de Tours-Hopital Bretonneau

Tours, France

Charite - Universitaetsmedizin Berlin

Berlin, Germany

Klinik fur Innere Medizin Hamatologie and Onkologie

Berlin, Germany

Universitaetsklinikum Koeln

Cologne, Germany

Universitaetsklinikum Essen

Essen, Germany

Johannes Gutenberg University

Mainz, Germany

Der Universität Munchen Medizinische Klinik III LMU

München, Germany

Ao Ss Antonio E Biagio Alessandria

Alessandria, Italy

Policlinico S. Orsola-Ematologia LA Seragnoli

Bologna, Italy

Istituto di Candiolo- Fondazione del Piemonte per l'Oncologia

Candiolo, Italy

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

Meldola, Italy

IRCCS Ospedale San Raffaele

Milan, Italy

VU University Medical Center

Amsterdam, Netherlands

Maastricht University Medical Center

Maastricht, Netherlands

Erasmus MC Cancer Institute

Rotterdam, Netherlands

Universitair Medisch Centrum Utrecht

Utrecht, Netherlands

Szpital Uniwersytecki nr 2 im dr. Jana Biziela

Bydgoszcz, Poland

Uniwersyteckie Centrum Kliniczne

Gdansk, Poland

Pratia-McM

Krakow, Poland

Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka

Słupsk, Poland

Maria Sklodowska-Curie Memorial Cancer Center and Institute

Warsaw, Poland

Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego

Wroclaw, Poland

National University Hospital

Singapore, Singapore

Singapore General Hospital

Singapore, Singapore

Dong-A University Hospital

Busan, South Korea

Keimyung University Dongsan Medical Center

Daegu, South Korea

National Cancer Center

Goyang-si, South Korea

Chonbuk National University Hospital

Jeonju, South Korea

Seoul National University Bundang Hospital

Seongnam-si, South Korea

Asan Medical Center

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Seoul National University Hospital

Seoul, South Korea

Severance Hospital, Yonsei University

Seoul, South Korea

Clinica Universidad de Navarra

Pamplona, Navarre, Spain

Hospital Germans Trias i Pujol

Badalona, Spain

Hospital Universitario Vall dHebron

Barcelona, Spain

Institut Catala de Oncologia

Barcelona, Spain

Hospital Universitario Fundacin Jimnez Daz

Madrid, Spain

Skåne University Hospital

Lund, Sweden

Karolinska University Hospital Huddinge

Stockholm, Sweden

Akademiska sjukhuset Uppsala University Hospital

Uppsala, Sweden

The Christie NHS Foundation Trust

Manchester, United Kingdom

Plymouth University School of Medicine- Derriford Hospital

Plymouth, United Kingdom

University Hospital Southampton NHS Foundation Trust

Southampton, United Kingdom

Royal Marsden NHS Foundation Trust

Sutton, United Kingdom

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (85)