drugset / Trial / NCT03995706

Neuro/Sacituzumab Govitecan/Breast Brain Metastasis/Glioblastoma/Ph 0

NCT03995706 ↗

NaSingle-groupOpen-labelTreatment

Summary

Single center, non-randomized, Phase 0 study. Sacituzumab Govitecan given preoperatively, followed by craniotomy with surgery or biopsy of brain tumors (GBM and metastatic brain tumors from Breast) and intraoperative tissue collection will follow with contemporaneous CSF (depending on tumor location) and whole blood (serum) sampling.

Timeline

Start
2019-07-17
Primary completion
2022-06-03
Completion
2024-03-20

Outcome

Met primary endpoint

paper In post-surgical tissue, the median total SN-38 was 249.8 ng/g for BCBM and 104.5 ng/g for rGBM, thus fulfilling the primary endpoint. PMID 39112464 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Sacituzumab Govitecan Monoclonal antibody 10 mg/kg Intravenous

Indications