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RECRUITING
NCT07297212
PHASE2

A Clinical Trial Testing the Safety of the Investigational Drug Pumitamig (BNT327) and How Well it Works in Patients With Recurrent Glioblastoma

Sponsor: BioNTech SE

View on ClinicalTrials.gov

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.

Official title: A Phase II, Multi-site, Open-label Trial Evaluating the Safety and Efficacy of Pumitamig and Bevacizumab as Monotherapy and Pumitamig in Combination With Temozolomide in Patients With Recurrent Glioblastoma

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

75

Start Date

2026-01-15

Completion Date

2029-07

Last Updated

2026-03-12

Healthy Volunteers

No

Interventions

DRUG

Pumitamig

Intravenous (IV) infusion

DRUG

Bevacizumab

IV infusion

DRUG

Temozolomide

Oral

Locations (1)

Beijing Tiantan Hospital, Capital Medical University

Beijing, China