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An open-label dose escalation study to estimate maximum tolerated dose (MTD), identify dose-limiting toxicities (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 (SoC), in adult patients with newly diagnosed glioblastoma (GBM).

Status
Not yet recruiting
Phases
Phase 1
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-515128-35-00
Acronym
DBP-053-01
Enrollment
27
Registered
2024-09-11
Start date
Unknown
Completion date
Unknown
Last updated
2024-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glioblastoma

Interventions

None listed

Sponsors

Double Bond Pharmaceutical AB
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Countries

Germany, Netherlands

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026