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Brief Title: Safety and Efficacy of L19TNF in Patients With Isocitrate Dehydrogenase (IDH) Wildtype WHO Grade III / IV Glioma at First Relapse
Official Title: A Study to Evaluate the Safety and Efficacy of the Tumor-targeting Human Antibody-cytokine Fusion Protein L19TNF in Patients With Isocitrate Dehydrogenase (IDH) Wildtype WHO Grade III / IV Glioma at First Relapse
Study ID: NCT03779230
Brief Summary: Open label, non-randomized, mono-center Phase I/II study in subjects with IDH-wildtype WHO grade III / IV glioma at first relapse.
Detailed Description: The purpose of this study is to explore the safety and efficacy profile of the antibody-cytokine fusion protein L19TNF in patients with isocitrate dehydrogenase (IDH) wildtype WHO grade III / IV glioma at first relapse Phase I: The primary objective of this phase is to evaluate the safety of L19TNF in patients with IDH-wildtype WHO grade III / IV glioma at first relapse and to establish and confirm the recommended dose (RD) for phase II. Phase II: The primary objective of this phase is to evaluate antitumor activity of L19TNF in patients with IDH-wildtype WHO grade III / IV glioma at first relapse.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Inselspital Bern, Bern, , Switzerland
CHUV Départment d'Oncologie, Lausanne, , Switzerland
Universitatspital Zurich - Klinik fur Neurologie & Hirntumorzentrum, Zürich, , Switzerland
Name: Tobias Weiss, MD
Affiliation: Universitätsspital Zürich
Role: PRINCIPAL_INVESTIGATOR