Health Trials

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

ConditionGlioma
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorPhilogen S.p.A.

About this trial

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.

Eligibility criteria

Qualifiers

Age ≥18

COHORT 1: Grade ≥2 oligodendroglioma or astrocytoma with planned resection, tumor tissue from prior resection must be available

COHORT 2A: Grade ≥2 oligodendroglioma

COHORT 2B1: Grade ≥2 oligodendroglioma previously treated with lomustine as monotherapy or in combination

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • L19TNF
  • L19TNF and TMZ
  • L19TNF and CCNU
  • L19TNF monotherapy
  • L19TNF and TMZ in recurrent astrocytoma
  • L19TNF and CCNU in recurrent astrocytoma
  • L19TNF monothery in recurrent oligodendroglioma

Treatment groups

52 Participants
are divided into 7 treatment groups

7

Treatment groups

See each treatment group below.

Locations

This trial has no locations

Sponsors and collaborators

Philogen S.p.A.

Lead sponsor

Source ClinicalTrials.gov