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

Sponsor
Philogen S.p.A.
Study ID
NCT07120984
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • L19TNF — BIOLOGICAL
    1 cycle of TNF before resection and 6 cycles after surgery
  • L19TNF and TMZ — BIOLOGICAL
    6 cycles of 28 days with L19TNF and TMZ
  • L19TNF and CCNU — BIOLOGICAL
    6 cycles of 6 weeks of L19TNF and CCNU every 6 weeks
  • L19TNF monotherapy — BIOLOGICAL
    6 cycles of 6 weeks with L19TNF
  • L19TNF and TMZ in recurrent astrocytoma — BIOLOGICAL
    6 cycles of 28 days with L19TNF (D1, D3, D5) and temozolomide chemotherapy TMZ (D1-5).
  • L19TNF and CCNU in recurrent astrocytoma — BIOLOGICAL
    6 cycles of 6 weeks of L19TNF (D1, D3, D5, D22, D24 and D26) and CCNU (D1) every 6 weeks
  • L19TNF monothery in recurrent oligodendroglioma — BIOLOGICAL
    6 cycles of 6 weeks with L19TNF

Study Details

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.

Key Dates

First listed
Aug 13, 2025
Start date
Jan 30, 2026
Status verified
Jul 2025
Primary completion
Jan 30, 2029
Completion
Jan 30, 2029

Study Design

Enrollment
52 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 1: perioperative cohort of patients with recurrent astrocytoma or oligodendroglioma
    patients will be treated with 1 cycle (D1, D3 and D5) L19TNF before resection and 4 weeks after surgery
  • Experimental: 2A:L19TNF Monotherapy for patients with recurrent oligodendroglioma
    patients with IDH-mutant oligodendroglioma, WHO Grade 2 or 3 at first progression after radiotherapy and one line of systemic chemotherapy, are treated with up to 6 cycles of 6 weeks with L19TNF
  • Experimental: 2B1: L19TNF plus TMZ for patients with recurrent oligodendroglioma
    patients with IDH-mutant oligodendroglioma, WHO Grade 2 or 3 at first progression after radiotherapy and one line of systemic CCNU-based chemotherapy, are treated with L19TNF and temozolomide chemotherapy TMZ
  • Experimental: 2B2: L19TNF plus CCNU for patients with recurrent oligodendroglioma
    patients with IDH-mutant oligodendroglioma, WHO Grade 2 or 3 at first progression after radiotherapy and one line of systemic temozolomide chemotherapy, are treated with L19TNF and CCNU
  • Experimental: 3A: L19TNF monotherapy for patients with recurrent astrocytoma
    patients with IDH-mutant astrocytoma, WHO Grade 2, 3 or 4 at first progression after radiotherapy and one line of systemic chemotherapy, are treated with L19TNF
  • Experimental: 3B1: L19TNF plus TMZ for patients with recurrent astrocytoma
    patients with IDH-mutant astrocytoma, WHO Grade 2, 3 or 4 at first progression after radiotherapy and one line of systemic CCNU-based chemotherapy, are treated with L19TNF and temozolomide chemotherapy TMZ
  • Experimental: 3B2: L19TNF plus CCNU for patients with recurrent astrocytoma
    patients with IDH-mutant astrocytoma, WHO Grade 2, 3 and 4 at first progression after radiotherapy and one line of systemic chemotherapy including temozolomide, are treated with L19TNFand CCNU

Primary Outcome Measure

Progression-free survival (PFS) [ Time Frame: The PFS rate will be assessed at 12 months (PFS-12) in IDH mutant astrocytoma and in oligodendroglioma. ]

Central Contacts

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