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ACTIVE NOT RECRUITING
NCT05180474
PHASE1/PHASE2

GEN1047 for Solid Tumors - First in Human (FIH) Trial

Sponsor: Genmab

View on ClinicalTrials.gov

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

Interventions

BIOLOGICAL

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