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

NCT07120984 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2025-08-13

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

L19TNF

1 cycle of TNF before resection and 6 cycles after surgery

BIOLOGICAL

L19TNF and TMZ

6 cycles of 28 days with L19TNF and TMZ

BIOLOGICAL

L19TNF and CCNU

6 cycles of 6 weeks of L19TNF and CCNU every 6 weeks

BIOLOGICAL

L19TNF monotherapy

6 cycles of 6 weeks with L19TNF

BIOLOGICAL

L19TNF and TMZ in recurrent astrocytoma

6 cycles of 28 days with L19TNF (D1, D3, D5) and temozolomide chemotherapy TMZ (D1-5).

BIOLOGICAL

L19TNF and CCNU in recurrent astrocytoma

6 cycles of 6 weeks of L19TNF (D1, D3, D5, D22, D24 and D26) and CCNU (D1) every 6 weeks

BIOLOGICAL

L19TNF monothery in recurrent oligodendroglioma

6 cycles of 6 weeks with L19TNF

Sponsors & Collaborators

  • Philogen S.p.A.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-30
Primary Completion
2029-01-30
Completion
2029-01-30

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07120984 on ClinicalTrials.gov