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

NCT07297212 | Recruiting Phase 2

• 1 other identifier: BNT327-10
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Recurrent Glioblastoma

Keywords

Bispecific antibody; Immunotherapy; Immunotherapy in combination with chemotherapy; Brain tumor; Programmed death-ligand 1 (PD-L1); Vascular endothelial growth factor(-A) (VEGF-A)

Outcome Measures

Primary Outcomes (3)

• Confirmed overall response rate (ORR)

  For Treatment Arms 1 and 2 only. Defined as the percentage of study participants in whom a confirmed complete response (CR) or confirmed partial response (PR) (assessed by the blinded independent central review \[BICR\] per RANO 2.0) is observed as best overall response.

  Up to 24 months

• Occurrence of treatment emergent adverse events (TEAEs) by severity

  According to (United States National Cancer Institute) Common Terminology Criteria for Adverse Events version 5.0 \[CTCAE v5.0\]). By relationship. For Treatment Arms 1 and 3 only.

  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

  For Treatment Arms 1 and 3 only.

  Up to 24 months

Secondary Outcomes (10)

• Confirmed ORR

  Up to 24 months

• Progression free survival (PFS)

  Up to 24 months

• PFS at 6 months

  At 6 months from time of randomization

• Duration of response

  Up to 24 months

• Disease control rate

  Up to 24 months

Study Arms (3)

Arm 1: Pumitamig Monotherapy

EXPERIMENTAL

Drug: Pumitamig

Arm 2: Bevacizumab Monotherapy

ACTIVE COMPARATOR

Drug: Bevacizumab

Arm 3: Pumitamig + temozolomide

EXPERIMENTAL

Drug: Pumitamig; Drug: Temozolomide

Interventions

Pumitamig DRUG

Intravenous (IV) infusion

Also known as: PM8002, BNT327, BMS-986545

Arm 1: Pumitamig Monotherapy; Arm 3: Pumitamig + temozolomide

Bevacizumab DRUG

IV infusion

Arm 2: Bevacizumab Monotherapy

Temozolomide DRUG

Oral

Arm 3: Pumitamig + temozolomide

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 the study treatment.
• Have a stable dose of steroids ≥7 days before the contrast-enhanced scan.
• Have adequate organ function, as defined in the protocol.

You may not qualify if:

• Have received any of the following therapies or drugs before study enrollment:
• Any anticancer therapies, including systemic, palliative, biologic, immunostimulatory, or immunosuppressive treatment within 4 weeks (or five half-lives, whichever is longer) before starting the study treatment.
• PD(L)-1/VEGF bispecific antibodies, cluster of differentiation (CD)137 agonists or other immune checkpoint blockade therapies including monotherapy with either category or combinations thereof.
• Systemic corticosteroids (at a dosage greater than 2 mg/day of dexamethasone or an equivalent dose of other corticosteroids) within 7 days before starting the study treatment.
• Vaccinations with live attenuated vaccine(s) within 4 weeks before starting the study treatment.
• Broad-spectrum intravenous antibiotics therapy within 2 weeks before starting the study treatment.
• Any non-study investigational medicinal product within five half-lives of the first dose or within 4 weeks, whichever is longer, before starting the study treatment in this study or ongoing participation in the active treatment phase of another interventional clinical study.
• Have had more than one recurrence of GBM.
• Are allergic to dacarbazine and temozolomide.
• Have known leptomeningeal disease, extracranial disease, or multicentric disease.
• Have been diagnosed with secondary GBM (i.e., glioblastomas that progress from low grade diffuse astrocytoma or anaplastic astrocytoma).
• Have previously received radiotherapy with anything other than standard radiotherapy (i.e., focally directed radiation).
• Have received prior interstitial brachytherapy, interstitial thermal therapy, implanted chemotherapy, or therapeutics delivered by local injection or convection-enhanced drug delivery. Participants who had prior treatment with Gliadel® wafers and who had concurrent use of devices such as Tumor Treating Fields are excluded.
• Have uncontrolled hypertension or poorly controlled diabetic conditions as specified in the protocol before study enrollment.
• Are unable (due to existent medical condition, e.g., pacemaker or implantable cardioverter defibrillator device) or unwilling to have a head contrast-enhanced MRI.

Sponsors & Collaborators

• BioNTech SE: lead
• Bristol-Myers Squibb: collaborator
• BioNTech (Shanghai) Pharmaceuticals Co., Ltd.: collaborator

Study Sites (6)

Beijing Tiantan Hospital, Capital Medical University

Beijing, 100070, China

RECRUITING

Affiliated Tumor Hospital of Chongqing Medical University

Chongqing, 350209, China

RECRUITING

Affiliated Cancer Hospital of Shandong First Medical University

Jinan, 250117, China

RECRUITING

Huashan Hospital, Fudan University

Shanghai, 201107, China

RECRUITING

Shenzhen Second People's Hospital

Shenzhen, 518000, China

RECRUITING

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, 430030, China

RECRUITING

MeSH Terms

Conditions

Glioblastoma; Brain Neoplasms

Interventions

Bevacizumab; Temozolomide

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• BioNTech Responsible Person

  BioNTech SE

  STUDY DIRECTOR

Central Study Contacts

BioNTech clinical trials patient information

CONTACT

+49 6131 9084; patients@biontech.de

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2025
• First Posted: December 22, 2025
• Study Start: January 15, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): July 1, 2029
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (6)