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Advanced Solid Tumor CancerPhase 1/2NCT07455734

Early-phase Trial to Assess the Safety and Preliminary Efficacy of BNT3214 in Adults With Advanced Solid Tumors

A Phase 1/2 study testing BNT3214 in people with Advanced Solid Tumor Cancer, run by BioNTech SE at 16 sites in 4 countries.

Recruiting

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

Sites and contacts
Official record
Search all trials

Trial summary

This study is the first time the drug BNT3214 (also referred to as PM8102) will be tested in people. It is designed to find out if the drug is safe and how well it works for adults with advanced solid tumors. The study will have three parts. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumor Cancer
What is being tested?
BNT3214
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
533 participants
Where
16 sitesin 4 countries
Study dates
30 Mar 2026to Oct 2030
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 aged ≥18 years of age inclusive at the time of giving informed consent.
  • Have at least one measurable tumor lesion based on RECIST v1.1. One lesion with prior local treatment (i.e., radiotherapy) can be considered measurable only if a disease progression from prior local treatment was demonstrated in the lesion per RECIST v1.1.
  • Eastern Cooperative Oncology Group performance status of 0 or 1.
  • Have a predicted life expectancy ≥3 months.
  • Have histologically or cytologically confirmed locally advanced, recurrent, or metastatic solid tumors that have progressed after at least one available standard therapy; or for whom the standard therapy is considered to be ineffective, inappropriate or intolerable; or for whom a clinical study of an investigational agent is a recognized standard of care.
  • Have adequate liver function as defined in the protocol.
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  • Have adequate renal function as defined in the protocol.
  • Have adequate hematologic function as defined in the protocol.
  • Have adequate coagulation as defined in the protocol.

Who cannot join

  • Untreated or symptomatic central nervous system (CNS) metastases and leptomeningeal disease.
  • Have a primary CNS malignancy.
  • Have active, or a history of, pneumonitis requiring treatment with steroids, or have active, or a history of, interstitial lung disease.
  • Have clinically significant pulmonary complications including, but not limited to, chronic obstructive pulmonary disease, restrictive lung disease, lung injury accompanied with autoimmune disease/connective tissue disorders.
  • Have a history of severe cardiovascular disease.
  • Have a history of significant hematologic toxicity to prior lines of therapy, as assessed by the investigator.
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  • Have uncontrolled hypertension or poorly controlled diabetes prior to allocation or randomization.
  • Have concurrent malignancy within 5 years prior to allocation or randomization (protocol defined exceptions apply).
  • Have unstable thrombotic event (e.g., deep vein thrombosis, arterial thrombosis, pulmonary embolism) requiring therapeutic intervention within 3 months prior to allocation or randomization, unless the participant has been fully treated (e.g., inferior vena cava filter placed) and/or adequately anticoagulated on a prophylactic dose.
  • Have known human immunodeficiency virus infection or known acquired immunodeficiency syndrome (protocol defined exceptions apply).
  • Have an active hepatitis B virus infection.
  • Have an active hepatitis C virus (HCV) infection. Participants with a negative HCV antibody test at screening or positive HCV antibody test followed by a negative HCV ribonucleic acid test at screening are eligible. Participants who have completed curative antiviral treatment with HCV viral load below the limit of quantification are allowed.
  • Have adverse reactions from prior anti-tumor therapy that have not returned to Grade ≤1, except for alopecia or toxicities (not specified elsewhere) considered irreversible and posing no safety risk to participants.
  • Have active, or history of, autoimmune disease (e.g., myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, psoriatic arthritis, vasculitis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, or multiple sclerosis) (protocol defined exceptions apply).
  • Have serious non-healing wounds, ulcer, or bone fracture.
  • Participants with lung cancer who have major coagulation disorders or an increased risk of hemorrhage (per investigator's clinical judgment)
  • Have a history of serious Grade ≥3 immune-related adverse events (irAEs) that led to treatment discontinuation of a prior immunotherapy. Participants with a history of Grade ≥3 irAEs that did not lead to treatment discontinuation of a prior immunotherapy should be evaluated and determined by investigators for potential safety risk.
  • Have a history of small bowel obstruction requiring hospitalization within the past 3 months prior to allocation or randomization.
  • Current or prior use of immunosuppressive medication within 14 days before the first dose of study treatment (protocol defined exceptions apply).
  • Have received any of the following therapies or drugs within the noted time intervals prior to allocation or randomization:
  • Systemic corticosteroids (at a dosage greater than 10 mg/day of prednisone or an equivalent dose of other corticosteroids) within 10 days prior to the initiation of study treatment.
  • Have been vaccinated with live, attenuated vaccine(s) within 4 weeks prior to initiation of the study treatment.
  • NOTE: Other protocol defined Inclusion/Exclusion criteria apply.

Trial locations and contacts

16 sites in 4 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

16 sites in 4 countries

Australia5 sites, 5 recruiting

  • Monash Medical Centre Clayton

    Clayton, 3168

    Recruiting

  • Austin Health

    Heidelberg Heights, 3081

    Not yet recruiting

  • Peter MacCallum Cancer Centre

    Melbourne, 3000

    Not yet recruiting

  • Scientia Clinical Research Ltd

    Randwick, 2031

    Not yet recruiting

  • Epworth HealthCare

    Richmond, 3121

    Recruiting

Other trials in Australia

China5 sites, 5 recruiting

  • Chongqing University Cancer Hospital

    Chongqing, 400030

    Recruiting

  • Nanfang Hospital of Southern Medical University

    Guangzhou, 510515

    Recruiting

  • Zhejiang Cancer Hospital

    Hangzhou, 310022

    Not yet recruiting

  • Shanghai East Hospital

    Shanghai, 200120

    Recruiting

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin, 300060

    Recruiting

Other trials in China

South Korea4 sites, 4 recruiting

  • Seoul National University Bundang Hospital

    Seongnam, 13620

    Not yet recruiting

  • Seoul National University Hospital

    Seoul, 3080

    Not yet recruiting

  • Severance Hospital, Yonsei University Health System

    Seoul, 3722

    Not yet recruiting

  • Asan Medical Center

    Seoul, 5505

    Not yet recruiting

Other trials in South Korea

Taiwan2 sites, 2 recruiting

  • China Medical University Hospital

    Taichung, 404332

    Not yet recruiting

  • National Taiwan University Hospital

    Taipei, 100225

    Not yet recruiting

Other trials in Taiwan

About this study

Official title: A Phase I/IIa, First-in-human, Open-label, Multi-site, Multi-regional, Dose Escalation Trial With Expansion Cohorts to Evaluate Safety and Preliminary Efficacy of BNT3214 in Adults With Advanced Solid Tumors

This study is the first time the drug BNT3214 (also referred to as PM8102) will be tested in people. It is designed to find out if the drug is safe and how well it works for adults with advanced solid tumors. The study will have three parts. The first two parts (Parts A and B) will focus on testing different amounts of BNT3214 to figure out the best and safest dose. The third part (Part C) will test selected doses of BNT3214 in multiple types of cancer.

Read the detailed description

Parts A and B will investigate the safety and tolerability of BNT3214. Part B is optional and will only be opened if emerging data from Part A indicates that an alternative BNT3214 dosing schedule may have a better benefit-risk profile for further development. Based on the available safety, pharmacokinetics (PK) or preliminary overall response data from Parts A and B, the study may progress to Part C. A study internal review committee will oversee the study to evaluate safety data as the study progresses and/or may recommend the dose levels (DLs) for the dose expansion, possible changes in the schedule of dosing, and expansion indications based on the totality of available data.

There will be no randomization in Parts A and B or the dose expansion cohorts of Part C. In the dose optimization cohorts of Part C, eligible participants will be randomized to one of two DLs selected from Parts A and B. In the dose expansion cohorts, participants will be enrolled into indication-specific cohorts as predefined or may be adjusted per safety, efficacy signals from Parts A and/or B.

Participants will receive BNT3214 for a maximum of 2 years or until disease progression per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), unacceptable toxicity, withdrawal of consent, loss of clinical benefit as determined by the investigator, lost to follow-up, death, or until the sponsor terminates the study or any other criterion for discontinuation is met, whichever occurs first.

Being tested
BNT3214
Keywords
Advanced solid tumors, Bispecific antibody, Immune checkpoint inhibitor

What participants receive

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

  • BNT3214Drug

    Also called PM8102

    Intravenous infusion

Study groups in NCT07455734
Study groupRoleWhat they receive
Part A - Escalating DLs of BNT3214ExperimentalUp to 7 DLs of BNT3214. In Part A, participants will stay on the same DL. In DL1 and DL2, intra-participant dose escalation will be allowed at the discretion of the investigator as specified in the protocol.
Receives: Drug: BNT3214
Part B (optional) - Selected DLs of BNT3214ExperimentalUp to 4 DLs. The starting dose for Part B will be at least one DL below the DL that has been declared safe for Part A.
Receives: Drug: BNT3214
Part C - Optimized DL of BNT3214ExperimentalOptimized dose of BNT3214 selected based on totality of data from Parts A and (if conducted) Part B.
Receives: Drug: BNT3214
Part C - Dose expansion of BNT3214ExperimentalDLs as recommended based on the totality of available data from previous parts.
Receives: Drug: BNT3214

What is being measured

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

  1. All parts - Number and percentage of participants with treatment emergent adverse events (TEAEs)

    Per DL/cohort. By United States National Cancer Institute Common Terminology Criteria for Adverse Events grading, seriousness, and relatedness.

    Measured: From the time of initiation of the first dose of BNT3214 until 90 days after the last dose of BNT3214

  2. All parts - Number and percentage of participants with dose interruptions, reductions, and discontinuation of BNT3214 due to TEAEs

    Per DL/cohort.

    Measured: Up to 24 months

  3. Parts A and B only - Number and percentage of participants with dose limiting toxicities (DLTs)

    During the DLT evaluation period

    Measured: From first dose up to 28 days

  4. Part C only - Objective response rate (ORR)

    Per DL/cohort. Defined as the percentage of participants in whom a confirmed complete response (CR) or partial response (PR) per RECIST v1.1 (based on the investigator's assessment) is observed as best overall response.

    Measured: Up to 30 months

Secondary outcomes (9)

  1. All parts - PK assessment: Area under the curve (AUC)

    Per DL/cohort. Derived for BNT3214 levels in plasma or serum (for Cycle 1, single-dose and Cycle 3, multiple-dose). If data permits.

    Measured: Up to 3 months from first dose of BNT3214

  2. All parts - PK assessment: Maximum concentration (Cmax)

    Per DL/cohort. Derived for BNT3214 levels in plasma or serum (for Cycle 1, single-dose and Cycle 3, multiple-dose). If data permits.

    Measured: Up to 3 months from first dose of BNT3214

  3. All parts - PK assessment: Time to maximum observed concentration (Tmax)

    Per DL/cohort. Derived for BNT3214 levels in plasma or serum (for Cycle 1, single-dose and Cycle 3, multiple-dose). If data permits.

    Measured: Up to 3 months from first dose of BNT3214

  4. All parts - PK assessment: Half-life (t1/2)

    Per DL/cohort. Derived for BNT3214 levels in plasma or serum (for Cycle 1, single-dose and Cycle 3, multiple-dose). If data permits.

    Measured: Up to 3 months from first dose of BNT3214

  5. Parts A and B only - ORR

    Per DL/cohort. Defined as the percentage of participants in whom a confirmed CR or PR per RECIST v1.1 (based on the investigator's assessment) is observed as best overall response.

    Measured: Up to 30 months

  6. All parts - Disease control rate

    Per DL/cohort. Defined as the percentage of participants in whom a confirmed CR or PR or stable disease (assessed at least 6 weeks after the first BNT3214 dose) per RECIST v1.1 (based on the investigator's assessment) is observed as best overall response.

    Measured: Up to 30 months

  7. All parts - Duration of response

    Per DL/cohort. Defined as the time from first objective response (CR or PR) to first occurrence of objective tumor progression (progressive disease) (based on the investigator's assessment) or death from any cause, whichever occurs first.

    Measured: Up to 30 months

  8. All parts - Anti-drug antibody (ADA) prevalence (percentage of participants who are ADA-positive)

    Either baseline or post-baseline. If data permits.

    Measured: Up to 90 days from the last dose of BNT3214

  9. All parts - ADA incidence (percentage of participants having treatment-emergent ADA)

    If data permits.

    Measured: Up to 90 days from the last dose of BNT3214

Timeline

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

  1. First posted6 Mar 2026
  2. Study start30 Mar 2026
  3. Primary completionOct 2030 (estimated)
  4. Study completionOct 2030 (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
Randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
533 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07455734
Sponsor's protocol ID
BNT3214-01
Status last verified
Aug 2026
First submitted
3 Mar 2026
Last updated
13 Aug 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 1/2 study testing BNT3214 in people with Advanced Solid Tumor Cancer, run by BioNTech SE at 16 sites in 4 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 9 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 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in Australia, China, South Korea, Taiwan. 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?

All parts - Number and percentage of participants with treatment emergent adverse events (TEAEs) (time frame: From the time of initiation of the first dose of BNT3214 until 90 days after the last dose of BNT3214). The study lists 4 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 NCT07455734.

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 13 Aug 2026.

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