Spots Global Cancer Trial Database for First-in-Human (FIH) Trial in Patients With Relapsed, Progressive or Refractory B-Cell Lymphoma
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Trial Identification
Brief Title: First-in-Human (FIH) Trial in Patients With Relapsed, Progressive or Refractory B-Cell Lymphoma
Official Title: A Phase 1/2, Open-label Safety Trial of GEN3013 in Patients With Relapsed, Progressive or Refractory B-Cell Lymphoma
Study ID: NCT03625037
Interventions
Study Description
Brief 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.
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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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 cedex, , 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
Dong-A University Hospital, Busan, , Korea, Republic of
Keimyung University Dongsan Medical Center, Daegu, , Korea, Republic of
National Cancer Center, Goyang-si, , Korea, Republic of
Chonbuk National University Hospital, Jeonju, , Korea, Republic of
Seoul National University Bundang Hospital, Seongnam-si, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Severance Hospital, Yonsei University, Seoul, , Korea, Republic of
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, Gdańsk, , Poland
Pratia-McM, Kraków, , Poland
Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka, Słupsk, , Poland
Maria Sklodowska-Curie Memorial Cancer Center and Institute, Warszawa, , Poland
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego, Wrocław, , Poland
National University Hospital, Singapore, , Singapore
Singapore General Hospital, Singapore, , Singapore
Clinica Universidad de Navarra, Pamplona, Navarra, 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
Contact Details
Name: Study Official
Affiliation: Genmab
Role: STUDY_DIRECTOR
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