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BNT3219

Phase 1

Advanced Solid Tumors | Small molecule | Oncology |BioNTech SE|Trials Updated: Oct 23, 2026

BNT3219 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

CONTROLLED
Total Trials1
Total Enrollment207

FDA Designations

No designations recorded

BNT3219 clinical trials

BNT3219 · 1 trial · 1 indication

Phase 1 1
NCT07893054A First-in-human Clinical Trial to Test if the Investigational Drug BNT3219 is Safe and Potentially Beneficial for People With Advanced Solid Tumors When Given Alone or Together With Other Investigational DrugsAdvanced Solid Tumors
NOT YET_RECRUITING207 Analytics
PHASE1NOT YET_RECRUITING
A First-in-human Clinical Trial to Test if the Investigational Drug BNT3219 is Safe and Potentially Beneficial for People With Advanced Solid Tumors When Given Alone or Together With Other Investigational Drugs
Advanced Solid Tumors
NCT07893054207
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Study Endpoints

Primary Endpoints

Occurrence of dose-limiting toxicities (dose escalation only)
Up to 21 days from the initiation of first dose of investigational medicinal product (IMP)

During the dose-limiting toxicity evaluation period. Per cohort.

Number and percentage of participants with treatment emergent adverse events (TEAEs) by TEAEs by National Cancer Institute Common Terminology Criteria for Adverse Events grading, seriousness, and relatedness
From the time of dosing until 90 days after the last dose of IMP

Per cohort.

Number and percentage of participants with dose interruptions, or discontinuations of study treatment due to TEAEs
From the first until the last dose of study treatment (up to approximately 30 months)

Per cohort.

Objective response rate (dose expansion only)
Up to 60 months

Defined as the proportion of participants with confirmed complete response (CR) or partial response (PR) (per the Response Evaluation Criteria in Solid Tumors version 1.1 \[RECIST v1.1\] based on the investigator's assessment) as best overall response.

Secondary Endpoints

Pharmacokinetic (PK) assessment: Area under the curve (AUC) derived from serum concentrations of BNT3219
Up to approximately 90 days after the last dose of IMP
PK assessment: Maximum concentration (Cmax) derived from serum concentrations of BNT3219
Up to approximately 90 days after the last dose of IMP
PK assessment: Time to reach maximum (peak) serum concentration (Tmax) derived from serum concentrations of BNT3219
Up to approximately 90 days after the last dose of IMP
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part A (dose escalation) - BNT3219 monotherapyEXPERIMENTALUp to 7 dose levels of BNT3219
Part A (dose expansion) - BNT3219 monotherapyEXPERIMENTALThe RP2D dose level will be determined from the dose escalation in Part A

Interventions

NameTypeDescription
BNT3219DRUGSolution for intravenous (IV) infusion
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo

Key Inclusion Criteria: * Are ≥18 years of age at the time of the informed consent form signature. Local laws will be followed if the age of consent is older. * Have histologically or cytologically confirmed locally advanced, recurrent, or metastatic solid tumors which have progressed after at leas...

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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 24, 2026NCT07893054NEW_TRIAL: changed
LOWOct 24, 2026NCT07893054NEW_TRIAL: changed
LOWOct 24, 2026NCT07893054NEW_TRIAL: changed
LOWOct 24, 2026NCT07893054NEW_TRIAL: changed

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