Not Yet RecruitingPhase 2

A Study to Evaluate the Safety and Efficacy of L19TNF With Alkylating Chemotherapy for Patients With Recurrent IDH-mutant Astrocytoma or Oligodendroglioma

52 participantsStarted 2026-01-30

Plain-language summary

The purpose of this study is to explore the safety and efficacy of the antibody-cytokine fusion protein L19TNF alone or in combination with alkylating chemotherapy in patients with recurrent IDH mutant glioma.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Age ≥18
✓. IDH-mutant glioma (according to WHO 2021 classification) at first recurrence or progression after alkylating chemotherapy:
✓. Measurable disease according to RANO 2.0 criteria.
✓. Documented IDH1 and/or IDH2 gene mutations detected by immunochemistry or sequencing.
✓. Karnofsky Performance Status (KPS) ≥ 70%.
✓. Life expectancy ≥ 3 months.
✓. Documented negative test for HIV-HBV-HCV. For HBV serology, the determination of HBsAg and anti-HBcAg Ab is required. In patients with serology documenting previous exposure to HBV, negative serum HBV-DNA is required. For HCV, HCV-RNA or HCV antibody test is required. Subjects with a positive test for HCV antibody but no detection of HCV-RNA indicating no current infection are eligible.
✓. Female patients: female patients must be either documented not Women Of Childbearing Potential (WOCBP)\* or must have a negative pregnancy test within 14 days of starting treatment. Additionally WOCBP must agree to use, from the screening to 6 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, progesterone-only or combined (estrogen- and progesterone-containing) hormonal contraception associated with inhibition of ovulation, intrauterine devices, intrauterine hormone-releasing systems, bilateral tubal occlusion or vasectomized partner.

Exclusion criteria

✕. Any therapy for recurrence/progression after alkylating chemotherapy, except resection.
✕. Therapy for glioma within 4 weeks of start of study treatment.
✕. Surgical resection of glioma within 4 weeks of start of study treatment.
✕. Stereotactic biopsy of glioma within 2 weeks of start of study treatment.
✕. Inability to undergo contrast-enhanced MRI.
✕. Known history of allergy to TNF or lomustine or temozolomide, any excipient in the study medication or any other intravenously administered human proteins/peptides/antibodies.
✕. Absolute neutrophil count (ANC) \< 1.5 x 10\^9/L; platelets \< 100 x 10\^9/L or hemoglobin (Hb) \< 9.0 g/dl.
✕. Chronically impaired renal function as indicated by creatinine clearance \< 60 mL/min/1.73m2 or for patients older than 65 years without albuminuria or proteinuria, creatinine clearance \< 45 mL/min/1.73m2.

What they're measuring

Progression-free survival (PFS)

Timeframe: The PFS rate will be assessed at 12 months (PFS-12) in IDH mutant astrocytoma and in oligodendroglioma.

Trial details

NCT IDNCT07120984

SponsorPhilogen S.p.A.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2029-01-30

Contact for this trial

Teresa Hemmerle, PhD

+390577017816 regulatory@philogen.com

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