drugset / Trial / NCT03995706
Neuro/Sacituzumab Govitecan/Breast Brain Metastasis/Glioblastoma/Ph 0
Phase 0
Completed
26 enrolled
The University of Texas Health Science Center at San Antonio
Gilead Sciences · collab
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sacituzumab Govitecan | Monoclonal antibody | 10 mg/kg | Intravenous |