NCT05304663

Safety and Efficacy of Different Administration Sequences of L19TNF With Lomustine in Glioblastoma at First Progression

A Study to Evaluate the Safety and Efficacy of Different Administration Sequences of L19TNF in Combination With Lomustine in Patients With Glioblastoma at First Progression

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Philogen S.p.A. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Open label phase I study in subjects with glioblastoma at first progression to explore two different administration schedules of lomustine for the combination with L19TNF (ARM 1 and ARM 2). Patients will be assigned in an alternating fashion to ARM 1 "Fractionating lomustine" or ARM 2 "Priming with L19TNF" as long as both treatment arms are open. Should one treatment arm be stopped as more or equal to two dose limiting toxicities occur in this treatment arm, then all remaining patients will be assigned to the treatment arm that is still open until also this treatment arm will be stopped.

Conditions

• Glioblastoma

Interventions

Type	Name	Description
DRUG	Onfekafusp alfa	Patients will be treated with 10 µg/kg L19TNF on Days 1, 3 and 5, and on Days 22, 24 and 26
DRUG	Lomustine	Arm 1: Patients will be treated in escalating cohorts of 6 patients with lomustine at different doses (60 mg/m2 and 75 mg/m2) on Day 1 and Day 22 (taken in the evening after L19TNF infusion) of a 42-day cycle for up to a maximum of 6 cycles. Arm 2: Patients will be treated in escalating cohorts of 6 patients with lomustine at different doses (90 mg/m2 and 110 mg/m2) on Day 5 (in the evening after infusion of L19TNF) of a 42-day cycle for up to a maximum of 6 cycles.

Timeline

• Start date: 2022-06-01
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2022-03-31
• Last updated: 2024-04-08