First-in-Human (FIH) Trial of GEN3009 in Subjects With Relapsed or Refractory B-Cell Non-Hodgkin Lymphomas
Stopped early · Phase 1/Phase 2
Conditions studied: Diffuse Large B-cell Lymphoma, Follicular Lymphoma, Marginal Zone Lymphoma, Small Lymphocytic Lymphoma, Mantle Cell Lymphoma, Chronic Lymphocytic Leukemia, High-grade B-cell Lymphoma, Primary Mediastinal Large B-cell Lymphoma
In brief
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").
Key facts
- Study ID
- NCT04358458
- Run by
- Genmab
- People needed
- 46
- Starts
- 2020-03-13
- Expected to finish
- 2023-07-28
- Last updated by the study team
- 2024-10-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Colorado Blood Cancer Institute — Denver, Colorado, United States
- University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States
- Ohio State University — Columbus, Ohio, 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
- UZ Leuven — Leuven, Belgium
- Rigshospitalet — Copenhagen, Denmark
- Odense Universitetshospital — Odense, Denmark
- Vejle Sygehus — Vejle, Denmark
- Amsterdam UMC, Locatie VUMC — Amsterdam, 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
Full record on ClinicalTrials.gov
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