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GEN1047 for Solid Tumors - First in Human (FIH) Trial
Sponsor: Genmab
Summary
The purpose of this trial is to measure the following in participants with solid tumors who receive GEN1047: * The side effects seen with GEN1047 * What the body does with GEN1047 once it is administered * What GEN1047 does to the body once it is administered * How well GEN1047 works against solid tumors The estimated trial duration for an individual participant is 8 months, consisting of a 28-day screening period, an estimated 3 month treatment period (the duration of treatment may vary for each participant), and an estimated 4 month post-treatment follow-up period (the duration of follow-up may vary for each participant). All participants will receive active drug; no one will be given placebo.
Official title: First-in-human, Open-label, Dose-escalation Trial With Expansion Cohorts to Evaluate Safety of GEN1047 in Subjects With Malignant Solid Tumors
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
179
Start Date
2021-12-13
Completion Date
2026-03-26
Last Updated
2026-03-03
Healthy Volunteers
No
Conditions
Interventions
GEN1047 is a bispecific antibody that induces T-cell mediated cytotoxicity of B7H4-positive tumor cells.
GEN1047 will be administered as an intravenous infusion. The dose-levels will be determined by the starting dose and the escalation steps taken in the trial.
Locations (36)
UCLA Department of Medicine Hematology Oncology
Los Angeles, California, United States
Yale University - Yale Cancer Center
New Haven, Connecticut, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
Case Western Reserve University
Cleveland, Ohio, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
Antwerp University Hospital
Edegem, Belgium
Universitair Ziekenhuis Leuven
Leuven, Belgium
Rigshospitalet (Copenhagen University Hospital)
Copenhagen, Denmark
CHU de Besancon
Besançon, France
Institut Bergonié
Bordeaux, France
Centre Léon Bérard
Lyon, France
Institut du Cancer de Montpellier
Montpellier, France
Institut Curie
Paris, France
Hôpital Cochin
Paris, France
CHU Poitiers - Hôpital la Milétrie
Poitiers, France
Institut Claudius Regaud
Toulouse, France
Institut Gustave Roussy
Villejuif, France
IEO Istituto Europeo di Oncologia
Milan, Italy
Fondazione IRCCS San Gerardo dei Tintori
Monza, Italy
University Medical Center Groningen
Groningen, Netherlands
Radboudumc
Nijmegen, Netherlands
Erasmus Medisch Centrum
Rotterdam, Netherlands
Med-Polonia Sp. z o.o
Poznan, Poland
Hospital Universitari Vall d'Hebron
Barcelona, Spain
Hospital Clinic de Barcelona
Barcelona, Spain
MD Anderson Cancer Center
Madrid, Spain
Hospital Ruber Internacional
Madrid, Spain
Centro Oncologico Clara Campal
Madrid, Spain
Hospital Universitary Fundacion Jimenez Diaz
Madrid, Spain
NEXT Oncology Madrid
Madrid, Spain
Clinica Universidad de Navarra
Pamplona, Spain
Hospital Clinico Universitario de Valencia
Valencia, Spain
St Bartholomews Hospital
London, United Kingdom
University College London Hospital
London, United Kingdom
The Christie Hospital
Manchester, United Kingdom