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NCT07297212PHASE2RECRUITING

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

Sponsor: BioNTech SE + Bristol-Myers Squibb, BioNTech (Shanghai) Pharmaceuticals Co., Ltd.

No open prediction endpoints

Endpoints are classified and published by ProgramSignal analysts.

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Key Facts

Study type
INTERVENTIONAL
Conditions
Recurrent Glioblastoma
Interventions
Pumitamig, Bevacizumab, Temozolomide
Enrollment
75 participants
Primary completion
Jan 2028
Study completion
Jul 2029
First posted
Dec 2025
Last updated
Apr 2026

Primary Endpoints (CT.gov)

Confirmed overall response rate (ORR)

Time frame: Up to 24 months

Occurrence of treatment emergent adverse events (TEAEs) by severity

Time frame: From the first dose of study treatment until 90 days after the last dose of study treatment (up to 27 months)

Occurrence of dose interruptions, reductions or discontinuations of study treatment due to TEAEs

Time frame: Up to 24 months

Secondary Endpoints

Confirmed ORR

Progression free survival (PFS)

PFS at 6 months

Eligibility Criteria

Key Inclusion 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 unless there is either: i) histopathologic confirmation of recurrent tumor, or ii) new enhancement on MRI outside of the radiotherapy treatment field. * Have been clinically evaluated as having relapsed or progressed disease with at least one measurable lesion as the targeted lesion based on RANO 2.0 criteria. * Have KPS ≥60. * Can swallow the medication and maintain oral administration. * Have a baseline brain MRI, not more than 14 days before starting th

Read full criteria on CT.gov →

✦ Analyst Commentary

Expert commentary on why this trial matters and what to watch for.

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Source

Open on ClinicalTrials.gov