drugset / Trial / NCT06463184
Study to Assess Xevinapant in Preoperative Subjects With Recurrent High-Grade Glioma (rHGG)
Phase 1
Withdrawn
H. Lee Moffitt Cancer Center and Research Institute
EMD Serono Research & Development Institute, Inc. · collab
NaSingle-groupOpen-labelTreatment
Summary
Researchers will investigate the ability of Xevinapant to cross the blood-brain barrier and exert anti-tumor effects on rHGG through activation of apoptosis. Researchers hypothesize that oral administration of Xevinapant has acceptable safety and tolerability in patients with recurrent HGG and demonstrate pharmacokinetic and pharmacodynamic effects in HGG tumors. To that end, Researchers will engage in a phase I "window of opportunity" translational clinical trial in patients undergoing a clinically-indicated craniotomy for resection of recurrent tumors to evaluate the impact of treatment on rHGG.
Timeline
- Start
- 2024-07-22
- Primary completion
- 2027-06
- Completion
- 2027-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Xevinapant | Small molecule | 400 mg | Oral |