An Open-label Dose Escalation Study to Estimate MTD, Identify DLTs and Study Pharmacokinetics Following a Single Dose of Intracranially Administered Temozolomide-based SI-053 as an add-on to the Current Standard of Care, in Adult Patients With Newly Diagnosed Glioblastoma
Latest Information Update: 12 Mar 2025
At a glance
- Drugs Temozolomide (Primary)
- Indications Glioblastoma
- Focus Adverse reactions
- Acronyms TARGLIO
- Sponsors Double Bond Pharmaceutical
Most Recent Events
- 10 Mar 2025 According to A Double Bond Pharmaceutical media release, candidate SI-053 received Orphan Drug Designation from the European Medicines Agency (EMA) in 2016 and has recently obtained Competent Authority and Ethics Committee approvals to initiate a Phase 1 clinical trial in two Western European countries.
- 04 Jul 2023 Planned End Date changed from 1 Aug 2025 to 1 Dec 2025.
- 04 Jul 2023 Planned primary completion date changed from 1 Jun 2025 to 1 Jul 2025.