RecruitingPhase 2NCT06336291

A Study With L19TNF in Combination With Lomustine in Patients With Glioblastoma at Progression or Recurrence

A Dose Optimization Study for L19TNF in Combination With Lomustine in Patients With Glioblastoma at Progression or Recurrence


Sponsor

Philogen S.p.A.

Enrollment

90 participants

Start Date

May 22, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The trial aims to collect safety, efficacy, exposure, dose- response, pharmacokinetic and pharmacodynamic information of the combination of L19TNF and lomustine at different dose levels in patients with Glioblastoma at progression or recurrence


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a drug called L19TNF (an immune-activating agent that targets tumor blood vessels) in combination with lomustine (a standard chemotherapy) in people with recurrent glioblastoma — a highly aggressive brain cancer that has come back after initial treatment. **You may be eligible if...** - You are 18 years or older - You have been diagnosed with glioblastoma (confirmed by biopsy), and the cancer has come back after treatment - Your MGMT promoter status has been tested - You are functionally able to carry out daily activities (Karnofsky Performance Status of 60% or higher) - You have tested negative for HIV, hepatitis B, and hepatitis C **You may NOT be eligible if...** - You have had more than two prior lines of treatment for glioblastoma - You have uncontrolled autoimmune disease or active severe infections - You have heart disease that would make the treatment unsafe - You are pregnant or breastfeeding - You are currently taking blood-thinning medication at therapeutic doses 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

7 μg/kg

DRUGL19TNF

10 μg/kg

DRUGL19TNF

13 μg/kg

DRUGLomustine

90 mg/m2

DRUGLomustine

110 mg/m2


Locations(8)

Northwestern Memorial Hospital

Chicago, Illinois, United States

Massachusetts General Hospital (MGH)

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center (BIDMC)

Boston, Massachusetts, United States

Dana-Farber Cancer Institute (DFCI)

Boston, Massachusetts, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, United States

University of Virginia (UVA)

Charlottesville, Virginia, United States

View Full Details on ClinicalTrials.gov

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NCT06336291


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