drugset / Trial / NCT05739942

Dose Finding Study of [177Lu]Lu-NeoB in Newly Diagnosed Glioblastoma and in Recurrent Glioblastoma

NCT05739942

Phase 1 Active not recruiting 42 enrolled Novartis Pharmaceuticals
Non-randomizedSingle-groupOpen-labelTreatment

Summary

This study will investigate different doses of \[177Lu\]Lu-NeoB in combination with RT and TMZ in participants with newly diagnosed glioblastoma, with methylated or unmethylated promoter, to assess the safety and efficacy of \[177Lu\]Lu-NeoB in combination with the SoC and in recurrent glioblastoma as single agent, to identify the recommended dose and to also explore the safety of the PET imaging agent \[68Ga\]Ga-NeoB and characterize its uptake in the tumor area.

Timeline

Start
2024-05-15
Primary completion
2028-11-08
Completion
2028-11-08

Drugs

EvaluationDrugModalityDoseRoute
Subject [177Lu]Lu-NeoB Other / unclassified Other
Subject [68Ga]Ga-NeoB Diagnostic / imaging agent Other

Indications