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BNT3210

Phase 1

Advanced Solid Tumors | Small molecule | Oncology |BioNTech SE|Trials Updated: Oct 21, 2026

BNT3210 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Oct 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment173

FDA Designations

No designations recorded

BNT3210 clinical trials

BNT3210 · 1 trial · 1 indication

Phase 1 1
NCT07886684A 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-TnAdvanced Solid Tumors
NOT YET_RECRUITING173 Analytics
PHASE1NOT YET_RECRUITING
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
Advanced Solid Tumors
NCT07886684173
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Study Endpoints

Primary Endpoints

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

Defined as the first 21 days. By dose level.

Occurrence of treatment emergent adverse events (TEAEs) by grade, seriousness, and relatedness
Up to approximately 3 years from first dose of study treatment

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.

Occurrence of dose interruptions, reductions, and discontinuation of BNT3210 due to TEAEs
Up to approximately 3 years from first dose of study treatment

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.

Part B only: Objective response rate (ORR)
Up to approximately 3 years from first dose of study treatment

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.

Secondary Endpoints

PK assessment: Area under the curve (AUC) derived from serum concentrations of BNT3210
Up to approximately 42 days after last dose of study treatment
PK assessment: Maximum concentration (Cmax) derived from serum concentrations of BNT3210
Up to approximately 42 days after last dose of study treatment
PK assessment: Time to Cmax (Tmax) derived from serum concentrations of BNT3210
Up to approximately 42 days after last dose of study treatment
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part A (dose escalation) - BNT3210 monotherapyEXPERIMENTALEscalating dose levels of BNT3210
Part B (dose optimization) - BNT3210 monotherapyEXPERIMENTALDoses will be as selected from Part A

Interventions

NameTypeDescription
BNT3210DRUGIntravenous infusion
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo

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 lesi...

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Competitive Landscape -Other Solid Tumors 10 trials (matched to "Advanced Solid Tumors")

CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK3PHASE2Pembrolizumab, Gardasil 9
Incyte CorporationINCY1PHASE2Retifanlimab
Novartis AG Sponsored ADRNVS1PHASE1KFA115
Iovance Biotherapeutics IncIOVA2PHASE2Aldesleukin
AstraZeneca PLCAZN1 - Trastuzumab deruxtecan
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Recent Changes (Last 90 Days)

LOWOct 21, 2026NCT07886684NEW_TRIAL: changed
LOWOct 21, 2026NCT07886684NEW_TRIAL: changed
LOWOct 21, 2026NCT07886684NEW_TRIAL: changed

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