A Clinical Trial Testing the Safety of the Investigational Drug Pumitamig (BNT327) and How Well it Works in Patients With Recurrent Glioblastoma
NCT07297212 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 75
Last updated 2026-04-29
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.
Conditions
Interventions
- DRUG
-
Pumitamig
Intravenous (IV) infusion
- DRUG
-
IV infusion
- DRUG
-
Oral
Sponsors & Collaborators
- collaborator INDUSTRY
-
BioNTech (Shanghai) Pharmaceuticals Co., Ltd.
collaborator INDUSTRY - lead INDUSTRY
Principal Investigators
-
BioNTech Responsible Person · BioNTech SE
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-01-15
- Primary Completion
- 2028-01-31
- Completion
- 2029-07-31
Countries
- China
Study Locations
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