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
Study ID
NCT07297212
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Jan 15, 2026
Status verified
Apr 2026
Primary completion
Jan 31, 2028
Completion
Jul 31, 2029

Study Design

Enrollment
75 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1: Pumitamig Monotherapy
  • Active Comparator: Arm 2: Bevacizumab Monotherapy
  • Experimental: Arm 3: Pumitamig + temozolomide

Primary Outcome Measure

Confirmed overall response rate (ORR) [ Time Frame: Up to 24 months ]

Central Contacts

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