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.
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
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.
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- 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.
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.
- Conditions
- Advanced Solid Tumors
- 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 group | Role | What they receive |
|---|---|---|
| Part A (dose escalation) - BNT3210 monotherapy | Experimental | Escalating dose levels of BNT3210 Receives: Drug: BNT3210 |
| Part B (dose optimization) - BNT3210 monotherapy | Experimental | Doses 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.
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
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
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
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)
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
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
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
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
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
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
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
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
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
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
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.
- First posted21 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionOct 2029 (estimated)
- Study completionApr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- More trials run by BioNTech SEThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- BioNTech SE
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- BioNTech (Shanghai) Pharmaceuticals Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- BioNTech Responsible Person, Study director, BioNTech SE
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