NCT07297212

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

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 75 (estimated)
• Sponsor: BioNTech SE · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Participants will be randomized to the two treatment Arms 1 and 2. After sponsor evaluation of the initial safety and efficacy signals from Arm 1, it will be determined whether to initiate Arm 3. Participants who have disease progression in Arm 2 may be eligible to receive pumitamig. There will be a screening period of up to 28 days, followed by a treatment period lasting up to 2 years. Participants will be followed-up for safety for up to 90 days after the last dose of study treatment or until the participant initiates new anticancer treatment (e.g., systemic, radiotherapy/surgery). Thereafter, survival follow-up will be conducted until the participant dies, the participant withdraws consent for survival status follow-up, loss of contact, or study termination (whichever occurs first).

Conditions

• Recurrent Glioblastoma

Interventions

Type	Name	Description
DRUG	Pumitamig	Intravenous (IV) infusion
DRUG	Bevacizumab	IV infusion
DRUG	Temozolomide	Oral

Timeline

• Start date: 2026-01-15
• Primary completion: 2028-01-01
• Completion: 2029-07-01
• First posted: 2025-12-22
• Last updated: 2026-03-12

Locations

1 site across 1 country: China