RecruitingPhase 1Phase 2NCT04573192

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

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


Sponsor

Philogen S.p.A.

Enrollment

142 participants

Start Date

Feb 19, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study evaluates the safety and effectiveness of combining a targeted drug called L19TNF with a chemotherapy drug called lomustine (CCNU) for people with glioblastoma (an aggressive brain tumor) that has come back after initial treatment. **You may be eligible if...** - You are 18 years old or older - You have been diagnosed with glioblastoma that has clearly returned or progressed for the first time - Your tumor is IDH-wildtype (a specific genetic marker) - Your overall health and ability to function are reasonably good (Karnofsky score ≥70%) - You have tested negative for HIV, hepatitis B, and hepatitis C - If you can become pregnant, you are using highly effective contraception **You may NOT be eligible if...** - This is your second or later recurrence of glioblastoma - You have severe other medical conditions - You are pregnant or breastfeeding - You have had prior treatment with lomustine - Your blood counts, liver, or kidney function are outside acceptable ranges Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGL19TNF

Cohort 1: 10 µg /kg L19TNF i.v. plus 90 mg/m2 lomustine Cohort 2: 10 µg /kg L19TNF i.v. plus 110 mg/m2 lomustine Cohort 3: 13 µg /kg L19TNF i.v. plus 110 mg/m2 lomustine

DRUGLomustine

Cohort 1: 10 µg /kg L19TNF i.v. plus 90 mg/m2 lomustine Cohort 2: 10 µg /kg L19TNF i.v. plus 110 mg/m2 lomustine Cohort 3: 13 µg /kg L19TNF i.v. plus 110 mg/m2 lomustine


Locations(15)

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

Cologne, 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

Milan, 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

Zurich, Switzerland

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NCT04573192


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