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Recurrent GlioblastomaPhase 2NCT07297212

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

A Phase 2 study testing Pumitamig, Bevacizumab and Temozolomide in people with Recurrent Glioblastoma, run by BioNTech SE at 6 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Recurrent Glioblastoma
What is being tested?
Pumitamig, Bevacizumab and Temozolomide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
6 sitesChina
Study dates
15 Jan 2026to Jul 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adults, aged 18 to 75 years inclusive at the time of giving informed consent. Local laws will be followed in countries where adulthood is defined as older than 18 years.
  • 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. Exception: For participants who discontinued temozolomide or switched to an alternative treatment prior to disease recurrence due to temozolomide intolerance, an interval of ≥6 months between the completion of radiotherapy and first disease recurrence is acceptable.
  • 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.
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  • 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.

Who cannot join

  • 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. For bevacizumab, the washout period is 4 weeks before the first dose of study treatment.
  • Programmed death-1 / programmed death-ligand 1/vascular endothelial growth factor bispecific antibodies, cluster of differentiation 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.
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  • 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.
  • Antiplatelet drugs, such as aspirin (>325 mg/day), clopidogrel (>75 mg/day), dipyridamole, ticlopidine or cilostazol, etc., within 10 days before starting the study treatment to avoid inclusion of participants who have used platelet aggregation inhibitors before the 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.
  • Have undergone major surgery, open biopsy, or significant traumatic injury within 28 days before starting the study treatment, or a planned/anticipated need for major surgery during the study treatment period. Placement of vascular infusion devices is allowed. Note: If participant has had major surgery, they must have recovered adequately from the toxicity and/or complications from the treatment prior to the initiation of study treatment.
  • Have received allogeneic hematopoietic stem cell transplantation or organ transplantation.
  • Have had other malignant tumors within 5 years before starting the study treatment. Exception: those who have been cured with local treatment (such as basal cell or squamous-cell carcinoma of the skin, superficial or noninvasive bladder cancer, carcinoma in situ of the cervix, ductal carcinoma in situ of the breast, and papillary carcinoma of thyroid and early-stage prostate cancer).
  • Have any of the following heart conditions within 6 months before starting the study treatment:
  • Myocardial infarction, unstable angina, acute coronary syndrome, coronary artery bypass grafting, congestive heart failure, aortic dissection, stroke, cerebrovascular accident or other Grade 3 and above cardiovascular events.
  • New York Heart Association functional classification ≥II heart failure or left ventricular ejection fraction <50%.
  • Ventricular arrhythmias requiring clinical intervention, second- to third-degree atrioventricular block, or congenital long QT syndrome. Participants with stable treated cardiac arrythmia/atrial fibrillation are allowed.
  • Mean QT interval corrected by Fridericia's method (QTcF) >480 ms (the electrocardiogram can be repeated at the discretion of the investigator).
  • Cardiac troponin I or T >2 × upper limit normal.
  • Have serious or non-healing wounds, ulcers, or (incompletely healed) bone fracture. This includes history (within 6 months before starting the study treatment) or risk of abdominal fistula, tracheoesophageal fistula, gastrointestinal perforation, or intra-abdominal abscess or esophageal and gastric varices, or acute gastrointestinal bleeding. In addition, the participant must have undergone correction (or spontaneous healing) of the perforation/fistula and/or the underlying process causing the fistula/perforation.
  • Have significant risk of hemorrhage (in the opinion of the investigator) or evidence of major coagulation disorders.
  • Have uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently). However, participants who are clinically stable following treatment for these conditions (including therapeutic thoracentesis or paracentesis or with indwelling catheters, e.g., PleurX) are allowed.
  • Have adverse events from prior antitumor therapy that have not returned to Grade 1 (graded by CTCAE v5.0 criteria) or below (unless the investigator determines that certain adverse events pose no safety risk to participants, such as hair loss or stable hypothyroidism under hormone replacement therapy).
  • Active colitis, including infectious, radioactive, ischemic enteritis, within 4 weeks before starting the study treatment.
  • History of serious allergic diseases, history of serious allergy to drugs (including unlisted investigational drug) or known allergy or intolerance to any ingredient of the study treatment.
  • Uncontrolled seizures after best medical therapy or other neurological conditions including clinically significant autoimmune neurological disorders which can increase risk for adverse effects or confound assessment of study outcomes as determined by the investigator.
  • Have superior vena cava syndrome or symptoms of spinal cord compression.
  • Have active, or a history of, pneumonitis requiring treatment with steroids, or have active or a history of interstitial lung disease.
  • Have a known history of tuberculosis that was not successfully treated.
  • NOTE: Other protocol defined Inclusion/Exclusion criteria apply.

Trial locations and contacts

6 sites in 1 country. Contact the study team or a site near you to ask about taking part.

BioNTech clinical trials patient information contact

+49 6131 9084 ext. 0

patients@biontech.de

6 sites in 1 country

China6 sites, 6 recruiting

  • Beijing Tiantan Hospital, Capital Medical University

    Beijing, 100070

    Recruiting

  • Affiliated Tumor Hospital of Chongqing Medical University

    Chongqing, 350209

    Recruiting

  • Affiliated Cancer Hospital of Shandong First Medical University

    Jinan, 250117

    Recruiting

  • Huashan Hospital, Fudan University

    Shanghai, 201107

    Recruiting

  • Shenzhen Second People's Hospital

    Shenzhen, 518000

    Recruiting

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

    Wuhan, 430030

    Recruiting

Other trials in China

About this study

Official title: 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

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.

Read the detailed description

Participants will be randomized to the two treatment Arms 1 and 2. After sponsor evaluation of the initial safety 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).

Being tested
Pumitamig, Bevacizumab, Temozolomide
Keywords
Bispecific antibody, Immunotherapy, Immunotherapy in combination with chemotherapy, Brain tumor, Programmed death-ligand 1 (PD-L1), Vascular endothelial growth factor(-A) (VEGF-A)
Medical subject headings
Glioblastoma, Brain Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PumitamigDrug

    Also called PM8002, BNT327, BMS-986545

    Intravenous (IV) infusion

  • BevacizumabDrug

    IV infusion

  • TemozolomideDrug

    Oral

Study groups in NCT07297212
Study groupRoleWhat they receive
Arm 1: Pumitamig MonotherapyExperimentalNot described
Receives: Drug: Pumitamig
Arm 2: Bevacizumab MonotherapyActive comparatorNot described
Receives: Drug: Bevacizumab
Arm 3: Pumitamig + temozolomideExperimentalNot described
Receives: Drug: Pumitamig; Drug: Temozolomide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to 24 months

  2. 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.

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

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

    For Treatment Arms 1 and 3 only.

    Measured: Up to 24 months

Secondary outcomes (10)

  1. Confirmed ORR

    Defined as the percentage of study participants in whom a confirmed CR or confirmed PR (assessed per RANO 2.0) is observed as best overall response. For Treatment Arms 1 and 2, assessment will be done by the investigator. For Treatment Arm 3, assessment will be done only by BICR.

    Measured: Up to 24 months

  2. Progression free survival (PFS)

    For Treatment Arms 1 and 2 only. Defined as the time from randomization to first documented tumor progression (progressive disease assessed by BICR and investigator per RANO 2.0) or death from any cause, whichever occurs first.

    Measured: Up to 24 months

  3. PFS at 6 months

    For Treatment Arms 1 and 2 only. Assessed by BICR and investigator per RANO 2.0.

    Measured: At 6 months from time of randomization

  4. Duration of response

    For Treatment Arms 1 and 2 only. Defined as the time from first objective response (CR or PR as assessed by BICR and investigator per RANO 2.0) to first occurrence of objective tumor progression (progressive disease as assessed by BICR and investigator per RANO 2.0), or death from any cause, whichever occurs first.

    Measured: Up to 24 months

  5. Disease control rate

    For Treatment Arms 1 and 2 only. Defined as the percentage of study participants in whom a confirmed CR or confirmed PR or confirmed minor response or stable disease (assessed by BICR and investigator per RANO 2.0) is observed as best overall response.

    Measured: Up to 24 months

  6. Overall survival (OS)

    For Treatment Arms 1 and 2 only. Defined as the time from participant randomization to death from any cause and at 6 and 12 months.

    Measured: Up to 42 months

  7. OS rate

    For Treatment Arms 1 and 2 only.

    Measured: At 6 and 12 months

  8. Pharmacokinetic (PK) assessment: Maximum concentration (Cmax) of pumitamig

    For Treatment Arms 1 and 3 only. As data permits.

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

  9. PK assessment: Minimum concentration (Cmin) of pumitamig

    For Treatment Arms 1 and 3 only. As data permits.

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

  10. The prevalence and incidence of anti-pumitamig antibodies

    For Treatment Arms 1 and 3 only. From before the first dose of study treatment until the last survival follow-up visit.

    Antidrug antibody (ADA) prevalence is the proportion of study participants with positive ADA against pumitamig at any point in time (baseline or post-baseline) during the study period.

    ADA incidence is the proportion of study participants with treatment-emergent ADA against pumitamig during the study period. Participants with treatment-emergent ADA includes study participants who were ADA negative or missing at baseline and became ADA positive post-baseline (treatment-induced ADA), and study participants who were ADA positive at baseline and post-baseline but had an increase in ADA titer of defined threshold from baseline to post-baseline (treatment-boosted ADA).

    Measured: Up to 27 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Dec 2025
  2. Study start15 Jan 2026
  3. Primary completionJan 2028 (estimated)
  4. Study completionJul 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
75 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07297212
Sponsor's protocol ID
BNT327-10
Status last verified
Oct 2026
First submitted
9 Dec 2025
Last updated
28 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pumitamig, Bevacizumab and Temozolomide in people with Recurrent Glioblastoma, run by BioNTech SE at 6 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact BioNTech clinical trials patient information (+49 6131 9084 ext. 0, patients@biontech.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Confirmed overall response rate (ORR) (time frame: Up to 24 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07297212.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.

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