drugset / Trial / NCT04573192

A Study to Evaluate Safety and Efficacy of L19TNF Plus Lomustine in Patients With Glioblastoma at First Progression

NCT04573192

Phase 1/2 Unknown 142 enrolled Philogen S.p.A.
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2021-02-19
Primary completion
2025-03
Completion
2025-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Lomustine Small molecule 90 mg/m2
Subject Lomustine Small molecule 110 mg/m2
Subject Onfekafusp alfa Protein / enzyme biologic 10 ug/kg Intravenous
Subject Onfekafusp alfa Protein / enzyme biologic 13 ug/kg Intravenous

Indications