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Brief Title: A Study to Evaluate Safety and Efficacy of L19TNF Plus Lomustine in Patients With Glioblastoma at First Progression
Official Title: A Study to Evaluate the Safety and Efficacy of the Tumor-targeting Human Antibody-cytokine Fusion Protein L19TNF Plus Lomustine in Patients With Glioblastoma at First Progression
Study ID: NCT04573192
Brief Summary: Glioblastomas are the most common and most aggressive primary brain tumors in adults. The prognosis is poor despite multimodal therapy with surgery, radiotherapy and chemotherapy. Therefore, novel treatments are urgently needed. L19TNF is a fully human fusion protein consisting of human tumor necrosis factor (TNF)-α fused to the L19 antibody in scFv format, specific to the extra-domain B of fibronectin. TNF not only induces apoptosis or necrosis in certain target cells, but also exerts inflammation and immunity. L19TNF selectively delivers TNF to the tumor site to spare normal tissues from undesired toxicity. Preclinical experiments with L19TNF have demonstrated tumor growth retardation in various mouse tumor models including models of glioma.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Hôpital Neurologique Pierre Wertheimer, Bron, , France
Hôpital Saint Louis, Paris, , France
Sorbonne University, AP-HP, Paris brain institute, Paris, , France
University Hospital Bonn, Bonn, , Germany
University Hospital Köln, Köln, , Germany
Klinikum rechts der Isar, München, , Germany
Universitatsklinikum Tubingen, Tübingen, , Germany
Azienda USL di Bologna IRCCS delle Scienze Neurologiche di Bologna, Bologna, , Italy
Fondazione IRCCS Istituto Neurologico Carlo Besta, Milano, , Italy
Istituto Oncologico Veneto IRCCS, Padova, , Italy
Azienda Ospedaliero-Universitaria Senese Policlinico Le Scotte, Siena, , Italy
AOU Città della Salute e della Scienza di Torino, Torino, , Italy
Inselspital Universitätsklinik für Medizinische Onkologie Bern, Bern, , Switzerland
Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, , Switzerland
Universitatspital Zurich - Klinik fur Neurologie & Hirntumorzentrum, Zürich, , Switzerland