drugset / Trial / NCT07297212
A Clinical Trial Testing the Safety of the Investigational Drug Pumitamig (BNT327) and How Well it Works in Patients With Recurrent Glioblastoma
Phase 2
Recruiting
75 enrolled
BioNTech SE
BioNTech (Shanghai) Pharmaceuticals Co., Ltd. · collabBristol-Myers Squibb · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This multi-site Phase II study will enroll adults with histologically confirmed diagnosis of World Health Organization (WHO) Grade IV glioblastoma (GBM), isocitrate dehydrogenase (IDH)-wildtype consistent with WHO central nervous system (CNS) 2021 criteria who have received prior first-line treatment including with at least radiotherapy and temozolomide, with a Karnofsky performance status (KPS) ≥60, adequate organ function, and at least one measurable lesion according to the response assessment in neuro-oncology (RANO) 2.0 criteria.
Timeline
- Start
- 2026-01-15
- Primary completion
- 2028-01
- Completion
- 2029-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Bevacizumab | Monoclonal antibody | — | Intravenous |
| Subject | Pumitamig | Protein / enzyme biologic | — | Intravenous |
| Subject | Temozolomide | Small molecule | — | Oral |