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Advanced Solid TumorPhase 1/2NCT07147348

A First-in-human, Dose Escalation and Indication Expansion Study of BNT3212 as Monotherapy or in Combination With BNT327 in Adults With Advanced Solid Tumors

A Phase 1/2 study testing BNT3212 and Pumitamig in people with Advanced Solid Tumor, run by BioNTech SE at 17 sites in 2 countries.

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

The aim of this first-in-human (FIH) open-label, multi-site study is to evaluate safety, tolerability, pharmacokinetics (PK), immunogenicity and preliminary clinical efficacy of BNT3212, including identification of the recommended dose of BNT3212 for use as monotherapy and with pumitamig (also known as BNT327 or… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumor
What is being tested?
BNT3212 and Pumitamig
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
375 participants
Where
17 sitesin 2 countries
Study dates
27 Aug 2025to Aug 2028
Phase
Phase 1/2
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants with histologically or cytologically confirmed locally advanced, recurrent, or metastatic solid tumors that have received prior adequate therapy in accordance with local practice for their tumor type and stage of disease; or for whom the standard therapy is considered inappropriate or intolerable.
  • Have at least one measurable lesion based on RECIST v1.1.
  • Eastern Cooperative Oncology Group performance status of 0 (fully active, able to carry out all pre-disease activities without restriction) or 1 (unable to perform physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature).
  • Predicted life expectancy of ≥3 months.
  • Left ventricular ejection fraction ≥50% by either echocardiography or multigated acquisition scan within 28 days prior to first dose of study treatment.
  • Adequate liver, renal, hematological, and coagulation function.
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  • Recovery to Grade 0-1 (or baseline) from adverse reactions related to prior anti cancer therapy except for:
  • Asymptomatic laboratory abnormalities such as elevated alkaline phosphatase, hyperuricemia, elevated serum amylase/lipase, and elevated blood glucose.
  • Toxicity that the investigator determined to have no safety risk, such as alopecia, Grade 2 peripheral neurotoxicity, hypothyroidism stabilized by hormone replacement therapy, etc.
  • The investigator considers discontinuation of protocol-defined anti-cancer therapies and restricted medications with protocol-defined washout periods as medically acceptable.
  • For Parts B and D only: Participants must be diagnosed with specific indications.

Who cannot join

  • Active infection (e.g., bacterial or fungal infections) requiring systemic treatment (e.g., severe pneumonia, bacteremia, sepsis), except oral antibiotics.
  • Participants with primary central nervous system (CNS) malignancies.
  • Active CNS metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms.
  • Unstable pleural effusion or ascites requiring thoracentesis or paracentesis within 14 days prior to initiation of study treatment.
  • Have active, or a history of, pneumonitis requiring treatment with steroids, or has active, or a history of, interstitial lung disease.
  • Clinically significant pulmonary complications.
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  • History of severe cardiovascular disease.
  • Have a history of significant hematologic toxicity to prior lines of therapy, as assessed by investigator, e.g., Grade 4 febrile neutropenia or recurrent/persistent Grade 3 to 4 neutropenia.
  • Have active or chronic corneal disorders or with any clinically significant corneal disease that prevents adequate monitoring of drug-induced keratopathy.
  • Have uncontrolled hypertension while on antihypertensive medicine or poorly controlled diabetes.
  • Concurrent malignancy within 5 years prior to study enrollment. Exceptions: basal cell carcinoma, squamous cell carcinoma of the skin, carcinoma in situ after radical resection.
  • Unstable thrombotic event (e.g., deep vein thrombosis, arterial thrombosis, pulmonary embolism).
  • Have adverse reactions from prior anti-tumor therapy that have not returned to Grade 1 (graded by NCI CTCAE v5.0 criteria) or below (unless the investigator determines that certain AEs pose no safety risk to participants, such as hair loss, Grade 2 peripheral neuropathy or stable hypothyroidism under hormone replacement therapy) are not eligible for the study.
  • For Parts C and D only: Prior treatment with PD-1/L1 and VEGF-A antibody combinations (including bispecific antibodies to PD-1/L1 and VEGF-A).
  • For Parts C and D only: Have active, or history of, autoimmune disease with risk of exacerbation following PD-L1 inhibition OR an immune deficiency (e.g., allogeneic hematopoietic stem cell transplantation or organ transplantation). Participants with protocol-specified conditions may be eligible.
  • For Parts C and D only: Have serious non-healing wounds, ulcer, or bone fracture.
  • For Parts C and D only: Have evidence of major coagulation disorders or other significant risks of hemorrhage.
  • For Parts C and D only: Have a history of serious Grade 3 or higher immune-related adverse events that led to treatment discontinuation of a prior immunotherapy.
  • For Parts C and D only: Have a history of small bowel obstruction requiring hospitalization within the past 3 months prior to the first dose of IMP.
  • For Parts C and D only: Have received:
  • Anticoagulant therapy for therapeutic purposes (except low molecular weight heparin) within 14 days prior to the first dose of IMP.
  • Antiplatelet drugs within 10 days prior to the initiation of study treatment.
  • NOTE: Other protocol defined Inclusion/Exclusion criteria apply.

Trial locations and contacts

17 sites in 2 countries. 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

17 sites in 2 countries

China11 sites, 11 recruiting

  • Beijing Cancer Hospital

    Beijing, 100142

    Recruiting

  • Anhui Provincial Hospital

    Hefei, 230061

    Recruiting

  • First Affiliated Hospital of Xinxiang Medical University

    Henan, 453003

    Recruiting

  • Hunan Province Cancer Hospital

    Hunan, 410006

    Not yet recruiting

  • Shandong University-Jinan Central Hospital

    Shandong, 250013

    Recruiting

  • Qilu Hospital of Shandong University'

    Shandong, 250062

    Not yet recruiting

  • Linyi Tumor Hospital

    Shandong, 276001

    Recruiting

  • Shanghai East Hospital

    Shanghai, 200120

    Recruiting

  • Shanghai GoBroad Cancer Hospital

    Shanghai, 200131

    Recruiting

  • Sichuan Cancer Hospital

    Sichuan, 610041

    Recruiting

  • Zhejiang Cancer Hospital

    Zhejiang, 310022

    Recruiting

Other trials in China

Australia6 sites, 6 recruiting

  • Cancer Research SA

    Adelaide, 5000

    Recruiting

  • Monash Medical Centre

    Clayton, 3168

    Recruiting

  • Peter MacCallum Cancer Centre

    Melbourne, 3000

    Recruiting

  • The Alfred Hospital

    Melbourne, 3004

    Recruiting

  • One Clinical Research

    Nedlands, 6009

    Not yet recruiting

  • Scientia Clinical Research Limited

    Randwick, 2031

    Recruiting

Other trials in Australia

About this study

Official title: A Phase I/II, First-in-human, Open-label, Dose Escalation and Indication Expansion Study of the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Efficacy of BNT3212 as Monotherapy or in Combination With BNT327 in Adults With Advanced Solid Tumors

The aim of this first-in-human (FIH) open-label, multi-site study is to evaluate safety, tolerability, pharmacokinetics (PK), immunogenicity and preliminary clinical efficacy of BNT3212, including identification of the recommended dose of BNT3212 for use as monotherapy and with pumitamig (also known as BNT327 or PM8002) as combination therapy, in adults with advanced solid tumors who have exhausted other treatment options.

Read the detailed description

This study will include four parts:

  • Part A (BNT3212 monotherapy - dose escalation)
  • Part B (BNT3212 monotherapy - dose expansion cohorts)
  • Part C (BNT3212 + pumitamig combination therapy - dose escalation)
  • Part D (BNT3212 + pumitamig combination therapy - dose expansion cohorts)

This study will follow a stepwise approach, beginning with a typical dose escalation in advanced solid tumors, followed by dose expansion in a range of indications. This design allows to gradually assess safety, preliminary efficacy, potential recommended Phase 2 dose (RP2D), and indications, while ensuring an acceptable benefit-risk balance along the way. Throughout this process, clinical data, including PK, biomarker, immunogenicity, safety, and efficacy, as well as non-clinical data, will be continuously collected and evaluated to support decision-making and ensure participant safety.

Being tested
BNT3212, Pumitamig
Keywords
BNT3212 (or PM1300), BNT327, Programmed death-ligand 1 (PD-L1), Vascular endothelial growth factor A (VEGF-A), Bispecific antibody, Antibody-drug conjugate (ADC), Combination with other investigational agents, Immunotherapy, Antibody, Programmed death 1 (PD-1)
Medical subject headings
Parkinson Disease 4, Autosomal Dominant Lewy Body

What participants receive

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

  • BNT3212Biological

    Intravenous infusion

  • PumitamigBiological

    Also called PM8002, BNT327

    Intravenous infusion

Study groups in NCT07147348
Study groupRoleWhat they receive
Part A - BNT3212 monotherapy (dose escalation)ExperimentalEscalating dose levels of BNT3212 to define the maximum tolerated dose (MTD) in participants with histologically or cytologically confirmed locally advanced/unresectable, recurrent, or metastatic malignant solid tumors who are refractory to or unable to tolerate standard treatment, or for whom no standard treatment is available.
Receives: Biological: BNT3212
Part B - BNT3212 monotherapy dose level (DL)1 (expansion cohort)ExperimentalIndication-specific cohort populations will be tested.
Receives: Biological: BNT3212
Part B - BNT3212 monotherapy DL2 (expansion cohort)ExperimentalIndication-specific cohort populations will be tested.
Receives: Biological: BNT3212
Part B - BNT3212 monotherapy DL3 (expansion cohort)ExperimentalIndication-specific cohort populations will be tested.
Receives: Biological: BNT3212
Part C - BNT3212 + pumitamig combination therapy (dose escalation)ExperimentalEscalating dose levels of BNT3212 plus a fixed dose of pumitamig to define the MTD in participants with histologically or cytologically confirmed locally advanced/unresectable, recurrent, or metastatic malignant solid tumors who are refractory to or unable to tolerate standard treatment, or for whom no standard treatment is available.
Receives: Biological: BNT3212; Biological: Pumitamig
Part D - BNT3212 DL1 + pumitamig combination therapy (expansion cohort)ExperimentalIndication-specific cohort populations will be tested. Pumitamig will be administered as fixed dose.
Receives: Biological: BNT3212; Biological: Pumitamig
Part D - BNT3212 DL2 + pumitamig combination therapy (expansion cohort)ExperimentalIndication-specific cohort populations will be tested. Pumitamig will be administered as fixed dose.
Receives: Biological: BNT3212; Biological: Pumitamig
Part D - BNT3212 DL3 + pumitamig combination therapy (expansion cohort)ExperimentalIndication-specific cohort populations will be tested. Pumitamig will be administered as fixed dose.
Receives: Biological: BNT3212; Biological: Pumitamig

What is being measured

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

  1. Parts A and C - Occurrence of dose limiting toxicities (DLTs) within a participant during the DLT observation period

    Per cohort.

    Measured: Up to 28 days after first dose of investigational medicinal product (IMP).

  2. All parts - Percentage of participants with treatment-emergent adverse events (TEAEs) including Grade ≥3, serious, and fatal TEAEs by relationship

    Per cohort. Adverse events (AEs) graded according to the National Cancer Institute Common Terminology Criteria for AEs version 5.0 (NCI CTCAE v5.0).

    Measured: From the time of the first dose of IMP until 90 days after the last dose of IMP, approximately up to 31 months.

  3. Parts A and C - Percentage of participants with dose interruptions or discontinuations of study treatment due to TEAEs

    Per cohort.

    Measured: From the time of the first until last dose of IMP, approximately up to 31 months.

  4. Parts B and D - Percentage of participants with dose interruptions, reductions or discontinuations of study treatment due to TEAEs

    Per cohort.

    Measured: From the time of the first until last dose of IMP, approximately up to 31 months.

  5. Parts B and D (expansion cohorts) - Objective response rate (ORR)

    Per cohort. ORR defined as the percentage of participants in whom a confirmed complete response (CR) or partial response (PR) (per Response Evaluation Criteria in Solid Tumors version 1.1 [RECIST v1.1] based on the investigator's assessment) is observed as best overall response.

    Measured: From first dose of IMP until end of study, approximately up to 31 months.

Secondary outcomes (10)

  1. All parts - PK assessment: Maximum concentration (Cmax) derived from serum/plasma concentrations

    Per cohort. For BNT3212 (conjugated antibody, total antibody, and unconjugated derivative of camptothecin, topoisomerase I inhibitor [iCPT]) and for pumitamig if in the combination cohorts, as data permits.

    Measured: From predose to 28 days after first dose of IMP.

  2. All parts - PK assessment: Area under the concentration-time curve (AUC0-t) derived from serum/plasma concentrations

    Per cohort. For BNT3212 (conjugated antibody, total antibody, and unconjugated iCPT) and for pumitamig if in the combination cohorts, as data permits.

    Measured: From predose to 28 days after first dose of IMP.

  3. All parts - PK assessment: Minimum concentration (Ctrough) derived from serum/plasma concentrations

    Per cohort. For BNT3212 (conjugated antibody, total antibody, and unconjugated iCPT) and for pumitamig if in the combination cohorts, as data permits.

    Measured: From predose until 90 days after the last dose of IMP.

  4. All parts - Anti-drug antibody (ADA) prevalence

    Per cohort and by dose level, derived from serum samples. Prevalence defined as the percentage of participants who are ADA positive (either baseline or post baseline), if data permits.

    Measured: For up to 90 days from the last dose of IMP.

  5. All parts - ADA incidence

    Per cohort and by dose level, derived from serum samples. Incidence defined as the percentage of participants having treatment-emergent ADA, if data permits.

    Measured: For up to 90 days from the last dose of IMP.

  6. All parts - Disease control rate (DCR)

    Per cohort. DCR defined as the percentage of participants with confirmed CR, PR, or stable disease (per RECIST v1.1 based on the investigator's assessment) as best overall response.

    Measured: From first dose of IMP until end of study, approximately up to 31 months.

  7. All parts - Duration of response (DOR)

    Per cohort. DOR defined as the time from first confirmed objective response (CR or PR per RECIST v1.1 based on the investigator's assessment) to first occurrence of objective tumor progression (progressive disease [PD] per RECIST v1.1 based on the investigator's assessment) or death from any cause, whichever occurs first.

    Measured: From first dose of IMP until end of study, approximately up to 31 months.

  8. All parts - Progression free survival (PFS)

    Per cohort. PFS based on the investigator's assessment defined as the time from first dose of trial treatment to the first objective tumor progression (PD per RECIST v1.1) or death from any cause, whichever occurs first.

    Measured: From first dose of IMP until end of study, approximately up to 31 months.

  9. All parts - Time to response (TTR)

    Per cohort. TTR, defined as the time from first dose of trial treatment to first confirmed objective response (CR or PR per RECIST v1.1 based on the investigator's assessment) in participants with a confirmed objective response.

    Measured: From first dose of IMP until end of study, approximately up to 31 months.

  10. All parts - Overall survival (OS)

    Per cohort. OS defined as the time from first dose of trial treatment to death from any cause.

    Measured: From first dose of IMP until end of study, approximately up to 31 months.

Timeline

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

  1. First posted29 Aug 2025
  2. Study start27 Aug 2025
  3. Primary completionNov 2027 (estimated)
  4. Study completionAug 2028 (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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
375 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07147348
Sponsor's protocol ID
BNT3212-01
Other IDs
CTR20253266
Status last verified
Jun 2026
First submitted
8 Aug 2025
Last updated
15 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing BNT3212 and Pumitamig in people with Advanced Solid Tumor, run by BioNTech SE at 17 sites in 2 countries.

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 11 inclusion and 23 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 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in China, Australia. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Parts A and C - Occurrence of dose limiting toxicities (DLTs) within a participant during the DLT observation period (time frame: Up to 28 days after first dose of investigational medicinal product (IMP).). The study lists 5 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 NCT07147348.

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 15 Jun 2026.

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