OncoMatch/Clinical Trials/NCT04573192
A Study to Evaluate Safety and Efficacy of L19TNF Plus Lomustine in Patients With Glioblastoma at First Progression
Is NCT04573192 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including L19TNF and Lomustine for glioblastoma.
Treatment: L19TNF · Lomustine — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Glioblastoma
Biomarker criteria
Required: IDH1 wild-type
IDH wildtype
Prior therapy
Cannot have received: treatment for glioblastoma at recurrence
Exception: surgery allowed
Prior treatment for glioblastoma at recurrence, except surgery
Cannot have received: lomustine (lomustine)
Prior treatment with lomustine
Lab requirements
Blood counts
ANC < 1.5 x 10^9/L; platelets < 100 x 10^9/L or haemoglobin (Hb) < 9.0 g/dl [excluded]
Kidney function
creatinine clearance < 60 mL/min or serum creatinine > 1.5 ULN [excluded]
Liver function
ALT, AST, ALP ≥ 2.5 x ULN or total bilirubin ≥ 2.0 x ULN [excluded]
Cardiac function
LVEF <55% or any other abnormalities observed during baseline ECG and echocardiogram investigations that are considered as clinically significant by the investigator. Subjects with current or a history of QT/QTc prolongation are excluded. Heart insufficiency (> Grade II, NYHA criteria). Clinically significant cardiac arrhythmias or requiring permanent medication. INR > 1.5 ULN.
Absolute neutrophil count (ANC) < 1.5 x 10^9/L; platelets < 100 x 10^9/L or haemoglobin (Hb) < 9.0 g/dl. Chronically impaired renal function as indicated by creatinine clearance < 60 mL/min or serum creatinine > 1.5 ULN. Inadequate liver function (ALT, AST, ALP ≥ 2.5 x ULN or total bilirubin ≥ 2.0 x ULN). INR > 1.5 ULN. Heart insufficiency (> Grade II, NYHA criteria). Clinically significant cardiac arrhythmias or requiring permanent medication. LVEF <55% or any other abnormalities observed during baseline ECG and echocardiogram investigations that are considered as clinically significant by the investigator. Subjects with current or a history of QT/QTc prolongation are excluded.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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