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Advanced Solid TumorsPhase 1/2NCT07886684

A Clinical Trial to Test if the Investigational Drug BNT3210 is Safe and Potentially Beneficial for People With Advanced Solid Tumors Known to Express the Tumor Marker Sialyl-Tn

A Phase 1/2 study testing BNT3210 in people with Advanced Solid Tumors, run by BioNTech SE.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

This study is the first time BNT3210 will be tested in people. It will evaluate different dose levels to find suitable doses and to understand how safe the treatment is and how it may help people with advanced solid tumors. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumors
What is being tested?
BNT3210
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
173 participants
Where
No sites listed yet
Study dates
Nov 2026to Apr 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

  • Have Eastern Cooperative Oncology Group performance status of 0 to 1.
  • Have measurable disease by investigator assessment according to RECIST v1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
  • Have documented disease progression on or after the prior line of therapy.
  • Have an archival formalin-fixed paraffin-embedded tumor tissue sample available or are willing to be biopsied to obtain a fresh tumor tissue sample.
  • Have a life expectancy of ≥3 months in the opinion of the investigator.
  • Have adequate organ, coagulation, and hematologic function as described in the protocol.
  • Have a histologically confirmed advanced/metastatic solid tumor.
  • Have no available standard of care therapy likely to confer clinical benefit in the opinion of the investigator. Participants must have received, be intolerant, or refused all available standard therapies.

Who cannot join

  • Have had major surgery within the 4 weeks (or 2 weeks for low-invasive cases, e.g., tumor biopsy, puncture) prior to the first dose of study treatment or are planned to undergo major surgery during the course of the study.
  • Have had prior allogeneic bone marrow transplantation or solid-organ transplantation.
  • Have had an inadequate washout period for prior anti-cancer treatment prior to the first dose of investigational medicinal product (IMP) as defined in the protocol.
  • Have received high doses of systemic steroids (>10 mg/day of prednisone or its equivalent) or other immunosuppressive therapy within 2 weeks prior to the first dose of IMP or have a condition requiring high doses of systemic steroids or other immunosuppressive therapy.
  • Have received any live attenuated vaccine within 4 weeks prior to the first dose of IMP or intend to receive a live attenuated vaccine during the study.
  • Have spinal cord compression, or clinical or radiologic findings indicative of impending cord compression.
Show all 14Show fewer
  • Have a history of (noninfectious) interstitial lung disease (ILD)/pneumonitis that requires steroids, current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
  • Have an active infection that requires systemic therapy within 2 weeks prior to the first dose of IMP.
  • Have any other primary malignancy within 3 years prior to the first dose of IMP.
  • Have unresolved toxicities from previous anti-cancer treatment, defined as toxicities (other than alopecia and pigmentation) not yet resolved according to (US) National Cancer Institute Common Terminology Criteria for Adverse Events version 6.0 Grade ≤1.
  • Have a history of relevant central nervous system (CNS) pathology or current relevant CNS pathology (e.g., seizure, paresis, aphasia, cerebrovascular ischemia/hemorrhage, severe brain injuries, dementia, Parkinson's disease, epilepsy requiring pharmacologic treatment).
  • Have a QT interval corrected by Fridericia's method (QTcF) prolongation to >450 ms if male or >470 ms if female.
  • Have, in the opinion of the treating investigator, any concurrent condition(s) that could pose an undue medical hazard or interfere with the interpretation of the study results.
  • NOTE: Other protocol defined Inclusion/Exclusion criteria apply.

Trial locations and contacts

No sites are listed yet. 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

About this study

Official title: A Phase I/II First-in-human, Open-label, Multi-site Trial to Evaluate the Safety and Preliminary Efficacy of BNT3210 in Participants With Advanced Solid Tumors Known to Express Sialyl-Tn

This study is the first time BNT3210 will be tested in people. It will evaluate different dose levels to find suitable doses and to understand how safe the treatment is and how it may help people with advanced solid tumors.

Read the detailed description

This study will consist of two parts (A and B). Part A will be a dose escalation to investigate the safety, tolerability, pharmacokinetics (PK) and preliminarily efficacy of BNT3210. Part B will be a dose optimization and proof-of-concept to further investigate the safety, tolerability and preliminarily anti-tumor activity of BNT3210 at different doses of BNT3210 selected from Part A.

No randomization will be performed in Part A. In Part B, participants will be randomized to different dose levels of BNT3210, as selected from Part A.

Being tested
BNT3210

What participants receive

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

  • BNT3210Drug

    Intravenous infusion

Study groups in NCT07886684
Study groupRoleWhat they receive
Part A (dose escalation) - BNT3210 monotherapyExperimentalEscalating dose levels of BNT3210
Receives: Drug: BNT3210
Part B (dose optimization) - BNT3210 monotherapyExperimentalDoses will be as selected from Part A
Receives: Drug: BNT3210

What is being measured

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

  1. Part A only: Occurrence of dose-limiting toxicities (DLTs) during the DLT evaluation period

    Defined as the first 21 days. By dose level.

    Measured: Up to 21 days from the initiation of first dose of study treatment

  2. Occurrence of treatment emergent adverse events (TEAEs) by grade, seriousness, and relatedness

    From first dose of BNT3210 until 35 days after the last dose of BNT3210 or the start of new anti-cancer treatment, whichever is earlier.

    Measured: Up to approximately 3 years from first dose of study treatment

  3. Occurrence of dose interruptions, reductions, and discontinuation of BNT3210 due to TEAEs

    From the time of initiation of the first dose of BNT3210 until administration of the last dose of BNT3210 or the start of new anti-cancer treatment, whichever is earlier.

    Measured: Up to approximately 3 years from first dose of study treatment

  4. Part B only: Objective response rate (ORR)

    Defined as the proportion 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: Up to approximately 3 years from first dose of study treatment

Secondary outcomes (11)

  1. PK assessment: Area under the curve (AUC) derived from serum concentrations of BNT3210

    By dose level at treatment cycle. If data permits.

    Measured: Up to approximately 42 days after last dose of study treatment

  2. PK assessment: Maximum concentration (Cmax) derived from serum concentrations of BNT3210

    By dose level at treatment cycle. If data permits.

    Measured: Up to approximately 42 days after last dose of study treatment

  3. PK assessment: Time to Cmax (Tmax) derived from serum concentrations of BNT3210

    By dose level at treatment cycle. If data permits.

    Measured: Up to approximately 42 days after last dose of study treatment

  4. PK assessment: Elimination half-life (t1/2) derived from serum concentrations of BNT3210

    By dose level at treatment cycle. If data permits.

    Measured: Up to approximately 42 days after last dose of study treatment

  5. Part A only: ORR

    Defined as the proportion 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 approximately 3 years from first dose of study treatment

  6. Disease control rate

    Defined as the proportion of participants in whom a confirmed CR or PR or stable disease (per RECIST v1.1 based on investigator's assessment) is observed as best overall response.

    Measured: Up to approximately 3 years from first dose of study treatment

  7. Duration of response

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

    Measured: Up to approximately 3 years from first dose of study treatment

  8. Anti-drug antibody (ADA) prevalence

    ADA prevalence is defined as the percentage of participants who are ADA positive at any point in time (either baseline or post-baseline).

    Measured: Up to approximately 42 days after last dose of study treatment

  9. ADA incidence

    ADA incidence is defined as the proportion of participants having treatment-emergent ADA during the study period.

    Measured: Up to approximately 42 days after last dose of study treatment

  10. Part B only: Progression free survival

    Defined as the time from first dose of BNT3210 to first objective tumor progression (progressive disease per RECIST v1.1), or death from any cause, whichever occurs first.

    Measured: Up to approximately 3 years from first dose of study treatment

  11. Part B only: Overall survival

    Defined as the time from first dose of BNT3210 to death from any cause.

    Measured: Up to approximately 3 years from first dose of study treatment

Timeline

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

  1. First posted21 Oct 2026
  2. Study startNov 2026 (estimated)
  3. Primary completionOct 2029 (estimated)
  4. Study completionApr 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
173 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07886684
Sponsor's protocol ID
BNT3210-01
Status last verified
Oct 2026
First submitted
15 Oct 2026
Last updated
21 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 1/2 study testing BNT3210 in people with Advanced Solid Tumors, run by BioNTech SE.

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 8 inclusion and 14 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: opening soon, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

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?

Part A only: Occurrence of dose-limiting toxicities (DLTs) during the DLT evaluation period (time frame: Up to 21 days from the initiation of first dose of study treatment). 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 NCT07886684.

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 21 Oct 2026.

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