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Safety and Efficacy of L19TNF in Patients With Isocitrate Dehydrogenase (IDH) Wildtype WHO Grade III / IV Glioma at First Relapse | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

Safety and Efficacy of L19TNF in Patients With Isocitrate Dehydrogenase (IDH) Wildtype WHO Grade III / IV Glioma at First Relapse

A Study to Evaluate the Safety and Efficacy of the Tumor-targeting Human Antibody-cytokine Fusion Protein L19TNF in Patients With Isocitrate Dehydrogenase (IDH) Wildtype WHO Grade III / IV Glioma at First Relapse

NCT03779230•Philogen S.p.A.

View on ClinicalTrials.gov

Summary

Open label, non-randomized, mono-center Phase I/II study in subjects with IDH-wildtype WHO grade III / IV glioma at first relapse.

Detailed Description

The purpose of this study is to explore the safety and efficacy profile of the antibody-cytokine fusion protein L19TNF in patients with isocitrate dehydrogenase (IDH) wildtype WHO grade III / IV glioma at first relapse Phase I: The primary objective of this phase is to evaluate the safety of L19TNF in patients with IDH-wildtype WHO grade III / IV glioma at first relapse and to establish and confirm the recommended dose (RD) for phase II. Phase II: The primary objective of this phase is to evaluate antitumor activity of L19TNF in patients with IDH-wildtype WHO grade III / IV glioma at first relapse.

Eligibility

Age

18 - 90 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Male or female, age 18 or more
•2. Patients with histologically confirmed IDH-wildtype WHO grade III / IV glioma at first relapse
•3. Radiographic demonstration of disease progression
•4. Presence of at least one lesion of bi-dimensionally measurable disease by MRI of at least 1 cm (10 mm) in the longest diameter on baseline MRI.
•5. Karnofsky Performance Score (KPS) ≥ 70%
•6. Documented negative test for HIV-HBV-HCV. For HBV serology: the determination of HBsAg, anti-HBsAg-Ab and anti-HBcAg-Ab is required. In patients with serology documenting previous exposure to HBV (i.e., anti-HBs Ab with no history of vaccination and/or anti-HBc Ab), negative serum HBV-DNA is required. For HCV: HCV-RNA or HCV antibody test. Subjects with a positive test for HCV antibody but no detection of HCV-RNA indicating no current infection are eligible.
•7. Female patients: negative pregnancy test for women of childbearing potential (WOCBP)\* within 14 days of starting treatment. WOCBP must agree to use, from the screening to six months following the last study drug administration, highly effective contraception methods, as defined by the "Recommendations for contraception and pregnancy testing in clinical trials" issued by the Head of Medicine Agencies' Clinical Trial Facilitation Group (www.hma.eu/ctfg.html) and which include, for instance, progesteron-only or combined (estrogen- and progesteron-containing) hormonal contraception associated with inhibition of ovulation, intrauterine devices, intrauterine hormone-releasing systems, bilateral tubal occlusion or vasectomized partner.
•Male patients: Male subjects able to father children must agree to use two acceptable methods of contraception throughout the study (e.g. condom with spermicidal gel). Double-barrier contraception is required.
•8. Negative TB test (e.g. Mantoux or Quantiferon assay).
•9. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
+1 more criteria

Exclusion Criteria

•1. Second or later glioma progression.
•2. Surgical resection or biopsy of glioma within 4 weeks of the start of study treatment.
•3. Subjects who participated in an investigational drug or device study within 4 weeks prior to study treatment start.
•4. Treatment with tumor-treating fields
•5. Radiotherapy within 6 weeks prior to study treatment start.
•6. Patients unable to undergo contrast-enhanced MRI.
•7. Patient taking herbal medications within 7 days prior to first dose of the study drug.
•8. Known history of allergy to TNF, excipient in study medication or any other intravenously administered human proteins/peptides/antibodies.
•9. Absolute neutrophil count (ANC) \< 1.5 x 10\^9/L, platelets \< 100 x 10\^9/L or haemoglobin (Hb) \< 9.0 g/dl.
•10. Chronically impaired renal function as indicated by creatinine clearance \< 60 mL/min.
+21 more criteria

Locations (3)

Inselspital Bern

Bern, Switzerland

CHUV Départment d'Oncologie

Lausanne, Switzerland

Universitatspital Zurich - Klinik fur Neurologie & Hirntumorzentrum

Zurich, Switzerland

Key Dates

Start Date

May 31, 2019

Primary Completion Date

June 27, 2023

Completion Date

June 27, 2023

Last Updated

June 29, 2023

Enrollment

ACTUAL participants

Conditions

Glioma of Brain

Interventions

L19TNF

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 29, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Safety and Efficacy of L19TNF in Patients With Isocitrate Dehydrogenase (IDH) Wildtype WHO Grade III / IV Glioma at First Relapse

Inclusion Criteria

Exclusion Criteria

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