Spots Global Cancer Trial Database for First-in-Human (FIH) Trial of GEN3009 in Subjects With Relapsed or Refractory B-Cell Non-Hodgkin Lymphomas
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Trial Identification
Brief Title: First-in-Human (FIH) Trial of GEN3009 in Subjects With Relapsed or Refractory B-Cell Non-Hodgkin Lymphomas
Official Title: Safety and Efficacy of GEN3009 (DuoHexaBody®-CD37) in Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma - A First-in-Human, Open-label, Phase 1/2a Dose Escalation Trial With Dose Expansion Cohorts
Study ID: NCT04358458
Study Description
Brief Summary: The drug that will be investigated in the study is an antibody, GEN3009. Since this is the first study of GEN3009 in humans, the main purpose is to evaluate safety. Besides safety, the study will determine the recommended GEN3009 dose to be tested in a larger group of patients and assess preliminary clinical activity of GEN3009. GEN3009 will be studied in a broad group of cancer patients, having different kinds of lymphomas. All patients will get GEN3009 either as a single treatment (monotherapy) or in combination with another antibody-candidate for treatment of cancer in the blood. The study consists of two parts: Part 1 tests increasing doses of GEN3009 ("escalation"), followed by Part 2 which tests the recommended GEN3009 dose from Part 1 ("expansion").
Detailed Description: This trial will be conducted in 2 parts: Part 1 (Dose Escalation) and Part 2 (Dose Expansion). All subjects in Part 1 will receive GEN3009, administered at various dose levels in 28-day cycles. Dose Limiting Toxicity (DLT) will be assessed during the first treatment cycle of Part 1 and the Maximum Tolerated Dose (MTD) and/or Recommended phase 2 dose (RP2D) will be identified. Subjects in Part 2 will be treated with the Part 1-defined RP2D of GEN3009. Some subjects will receive GEN3009 in combination of a fixed dose of another antibody-candidate. Subjects in Part 2 are assigned either to one of 3 groups: Part 2 Monotherapy (hereafter referred to as 'Part 2A'), Part 2 Combination Safety Run-in ('Part2B') or Part 2 Combination ('Part2C'). Various types of B-cell NHLs are studied, including diffuse large B cell lymphoma (DLBCL), high-grade B cell lymphoma (HGBCL), mantle cell lymphoma (MCL), primary mediastinal large B-cell lymphoma (PMBCL), follicular lymphoma (FL), marginal zone lymphoma (MZL) and chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL).
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Arizona Cancer Center, Tucson, Arizona, United States
City Of Hope National Medical Center, Duarte, California, United States
Colorado Blood Cancer Institute, Denver, Colorado, United States
University of Iowa Holden Comprehensive Cancer Center, Iowa City, Iowa, United States
University of Michigan, Ann Arbor, Michigan, United States
University Hospitals Cleveland Medical Center, Cleveland, Ohio, United States
Ohio State University, Columbus, Ohio, United States
OHSU Knight Cancer Institute, Portland, Oregon, United States
University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania, United States
Medical University of South Carolina (MUSC), Charleston, South Carolina, United States
The University of Texas Southwestern Medical Center, Dallas, Texas, United States
MD Anderson Cancer Center, Houston, Texas, United States
University of Washington - Seattle Cancer Care Alliance, Seattle, Washington, United States
GZA Ziekenhuizen, Antwerp, , Belgium
Grand Hôpital de Charleroi, Charleroi, , Belgium
UZ Leuven, Leuven, , Belgium
Rigshospitalet, Copenhagen, , Denmark
Odense Universitetshospital, Odense, , Denmark
Vejle Sygehus, Vejle, , Denmark
CHU de Nantes - Hotel Dieu, Nantes, , France
Centre Antoine Lacassagne, Nice, , France
Amsterdam UMC, Locatie VUMC, Amsterdam, , Netherlands
Universitair Medisch Centrum Groningen (UMCG), Groningen, , Netherlands
UMC Utrecht, Utrecht, , Netherlands
ICO Badalona - Hospital Universitari Germans Trias i Pujol, Badalona, Barcelona, Spain
ICO l'Hospitalet - Hospital Duran i Reynals, Barcelona, L'Hospitalet De Llobregat, Spain
Hospital Universitari Vall d'Hebron, Barcelona, , Spain
Hospital Clinic de Barcelona, Barcelona, , Spain
Hospital Universitario Fundacion Jimenez Diaz, Madrid, , Spain
Contact Details
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