NCT05432375

Study of Tinostamustine for Adjuvant Treatment of Glioblastoma

A Phase 1 Study to Investigate the Safety, Pharmacokinetics, and Efficacy of Tinostamustine, a Novel Alkylating and Deacetylase Inhibiting Molecule, as Adjuvant Treatment in Patients With Newly Diagnosed Unmethylated MGMT-promoter Glioblastoma

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Mundipharma Research Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study is designed as an open label, multi-center, Phase 1 study of single agent tinostamustine, used as adjuvant treatment in patients with newly diagnosed GBM who are MGMT unmethylated and have completed concomitant treatment with temozolomide and radiation. Treatment with adjuvant tinostamustine will start within 5 weeks of completion of concomitant temozolomide and radiation. The study is designed to define the MTD by evaluating toxicities during dose escalation. Tinostamustine will be administered on Day 1 of a 21-day treatment cycle. The total number of treatment cycles is 12 for patients who continue to benefit from treatment without disease progression or intolerable toxicity. Patients will enter a "3+3" design with dose escalation/de-escalation depending on safety from the last treated cohort.

Conditions

• Glioblastoma Multiforme

Interventions

Type	Name	Description
DRUG	Tinostamustine	infusion given over 60 minutes

Timeline

• Start date: 2022-07-01
• Primary completion: 2024-11-10
• Completion: 2024-11-10
• First posted: 2022-06-27
• Last updated: 2025-12-10

Locations

5 sites across 2 countries: Spain, Switzerland