Not yet recruitingNCT07886684Updated Oct 21, 2026

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 interventional study of BNT3210 in Advanced Solid Tumors, sponsored by BioNTech SE. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-21.

Sponsored by BioNTech SE · Phase 1/2, Interventional, and Treatment

Updated Oct 21, 2026Newly registeredGo to Updates ↓

Phase: Phase 1/2
Study type: Interventional
Enrollment: 173
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study 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 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 studied

Advanced Solid Tumors

In context

Lead sponsor

BioNTech SE is the lead sponsor of 76 studies on the registry; 25 are open to participants now.

Of its 33 completed or terminated interventional studies of FDA-regulated products, 26 (79%) have results posted.

Browse BioNTech SE studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Eligibility criteria

Key Inclusion Criteria:

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.

Key Exclusion Criteria:

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.
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.

Study design

Phase: Phase 1 / Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Sequential assignment
Masking: None (open label)
Enrollment: 173 participants (estimated)

Study arms

Experimental
Part A (dose escalation) - BNT3210 monotherapy
Escalating dose levels of BNT3210
Drug: BNT3210
Experimental
Part B (dose optimization) - BNT3210 monotherapy
Doses will be as selected from Part A
Drug: BNT3210

Interventions

DrugBNT3210
Intravenous infusion

What researchers measure

Primary outcomes

Part A only: Occurrence of dose-limiting toxicities (DLTs) during the DLT evaluation period
Defined as the first 21 days. By dose level.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to approximately 3 years from first dose of study treatment

Secondary outcomes

PK assessment: Area under the curve (AUC) derived from serum concentrations of BNT3210
By dose level at treatment cycle. If data permits.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to approximately 3 years from first dose of study treatment

Study locations

No study locations are listed for this record.

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Updates

1 registry update since Sep 25, 2026

Registered

First appeared on the registry. No changes since

Oct 21, 2026

Show all 1 update

Oct 21, 2026
First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT07886684
Lead sponsor: BioNTech SE
Collaborators: BioNTech (Shanghai) Pharmaceuticals Co., Ltd.
Responsible party: Sponsor
First posted: Oct 21, 2026
Start date: Nov 2026 (estimated)
Primary completion: Oct 2029 (estimated)
Completion: Apr 2030 (estimated)
Last update: Oct 21, 2026

Study contacts

BioNTech clinical trials patient information

Contact

patients@biontech.de

+49 6131 9084 ext. 0

BioNTech Responsible Person

study director · BioNTech SE

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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