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

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.

Trial Details

NCT ID
NCT07297212
Phase
PHASE2
Sponsor
BioNTech SE
Status
RECRUITING
Cancer Type
Glioblastoma (GBM) Brain Cancer
Interventions
  • Pumitamig
  • Bevacizumab
  • Temozolomide
Locations (sample)
  • Beijing, China|39.9075,116.39723
  • Chongqing, China|29.56026,106.55771
  • Jinan, China|36.66833,116.99722
  • Shanghai, China|31.22222,121.45806
  • Shenzhen, China|22.54554,114.0683

Key Eligibility Criteria

  • Adults, aged 18-75 years inclusive at the time of giving informed consent. Local laws will be followed if the age at consent is older.
  • Have a histologically confirmed diagnosis of WHO Grade IV GBM, IDH-wildtype consistent with WHO CNS 2021 criteria.
  • Have recurrent supratentorial GBM who have received prior treatment with at least radiotherapy and temozolomide.
  • Have first recurrence documented by magnetic resonance imaging (MRI), with an interval of at least 12 weeks after the end of prior radiotherapy unl…

For full eligibility, visit ClinicalTrials.gov.

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