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NCT05432375
Study of Tinostamustine for Adjuvant Treatment of Glioblastoma
EARLY_PHASE1 trial testing Tinostamustine in Glioblastoma Multiforme in 10 participants. Completed in 10 November 2024.
10 November 2024
Quick facts
| Lead sponsor | Mundipharma Research Limited |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 10 |
| Start date | 1 July 2022 |
| Primary completion | 10 November 2024 |
| Estimated completion | 10 November 2024 |
| Sites | 5 locations across Switzerland, Spain |
Drugs / interventions tested
- Tinostamustine — full drug profile →
Conditions studied
- Glioblastoma Multiforme — all drugs for Glioblastoma Multiforme →
Sponsor
Mundipharma Research Limited — full company profile →
Who can join
18 and older, any sex, with Glioblastoma Multiforme. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Epigenetics-targeted drugs: current paradigms and future challenges.
Dai W, Qiao X, Fang Y, Guo R, et al · · 2024 · cited 131× · PMID 39592582 · DOI 10.1038/s41392-024-02039-0 -
Tinostamustine (EDO-S101) and Its Combination with Celecoxib or Temozolomide as a Therapeutic Option for Adult-Type Diffuse Gliomas.
Pawlak W, Majchrzak-Celińska A. · · 2025 · cited 1× · PMID 39859375 · DOI 10.3390/ijms26020661
Verify or expand the search:
- PubMed search for NCT05432375
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Tinostamustine
Trials testing the same drug.
- NCT03903458 — Tinostamustine and Nivolumab in Advanced Melanoma · Phase 1 · unknown
- NCT03687125 — Tinostamustine Conditioning and Autologous Stem Cell · Phase 1, PHASE2 · terminated
- NCT03452930 — Tinostamustine With or Without Radiation Therapy in Treating Patients With Newly Diagnosed MGMT-Unmethylated Glioblastom · Phase 1 · completed
- NCT02576496 — Study of Tinostamustine, First-in-Class Alkylating HDACi Fusion Molecule, in Relapsed/Refractory Hematologic Malignancie · Phase 1 · completed
Other recruiting trials for Glioblastoma Multiforme
Currently open trials in the same condition.
- NCT06466031 — Application of FET-PET in Fusion With MRI in the Treatment of Glioblastoma Multiforme [TYR-GLIO] · NA · recruiting
- NCT06333899 — Lorlatinib for Newly-Diagnosed High-Grade Glioma With ROS or ALK Fusion · EARLY_PHASE1 · recruiting
- NCT05956821 — Treatment of Relapsed/Refractory Intracranial Glioma in Patients Under 22 Years of Age · Phase 1, PHASE2 · recruiting
- NCT06496971 — A Prospective Pivotal Study to Evaluate the Efficacy and Safety of Avastin® Bevacizumab (BEV) With or Without Microbubbl · Phase 3 · recruiting
- NCT06329570 — Safety and Efficacy of Bevacizumab in Combination With NaviFUS System for the Treatment of Recurrent Glioblastoma Multif · Phase 1, PHASE2 · recruiting
Other Mundipharma Research Limited trials
Trials by the same sponsor.
- NCT06794554 — Rezafungin for Treatment of Chronic Pulmonary Aspergillosis (CPA) in Adults With Limited Treatment Options · Phase 2 · recruiting
- NCT05534529 — Rezafungin Paediatric PK Study in Paediatric Subjects From Birth to <18 Years of Age · Phase 1 · terminated
- NCT04368559 — Study of Rezafungin Compared to Standard Antimicrobial Regimen for Prevention of Invasive Fungal Diseases in Adults Unde · Phase 3 · completed
- NCT03345485 — Study of the Safety, Pharmacokinetics and Efficacy of Tinostamustine in Patients With Advanced Solid Tumors. · Phase 1, PHASE2 · completed
- NCT02753712 — A Study to Evaluate the Effect of Fluticasone/Formoterol Breath Actuated Inhaler (BAI) or Relvar® Ellipta® DPI on Ventil · Phase 3 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05432375 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Mundipharma Research Limited
- Last refreshed: 10 December 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05432375.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing