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 (GLIOSTAR)

NCT04573192 Phase 1/Phase 2 UNKNOWN

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.

Details

Lead sponsor	Philogen S.p.A.
Phase	Phase 1/Phase 2
Status	UNKNOWN
Enrolment	142
Start date	2021-02-19
Completion	2025-12

Conditions

• Glioblastoma

Interventions

• L19TNF
• Lomustine

Primary outcomes

• For Phase 1: DLT — For Cohort 1 to Cohort 3 from Day 1 to Day 42 after the first administration of lomustine and study drug (Cycle 1)
  Occurrence of dose limiting toxicity (DLT) assessed by frequency and grade of adverse events (AE) according to CTCAE v.5.0.
• For Phase 2: Overall Survival — From beginning of treatment to 12 months
  Overall survival (OS) rate

Countries

France, Germany, Italy, Switzerland