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BNT314

Phase 1

Advanced Malignant Solid Tumor | Monoclonal antibody | Oncology |BioNTech SE|Last Updated: Jan 23, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment41
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06150183Safety and Preliminary Efficacy of BNT314 in Cancer Patients With Malignant Solid TumorsPHASE1 ACTIVE NOT_RECRUITING 41 — — Nov 30, 2023Mar 1, 2028Jan 23, 202614 United States, Belgium +4
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Study Endpoints
Primary Endpoints
Occurrence of dose-limiting toxicity within a cohort
21 days from the first dose administration
Number and percentage of patients with occurrence of treatment-emergent adverse events (TEAEs) including Grade ≥ 3, serious, fatal TEAE by relationship
from first dose of study treatment to 90 days after last dose of study treatment

In patients receiving at least one dose of BNT314 per cohort

Number and percentage of patients with occurrence of dose reduction and discontinuation of investigational medicinal product (IMP) due to TEAE
from first dose of study treatment to 90 days after last dose of study treatment

In patients receiving at least one dose of BNT314 per cohort

Number and percentage of patients with occurrence of Grade ≥ 3 abnormal safety laboratory parameters
from first dose of study treatment to 90 days after last dose of study treatment

In patients receiving at least one dose of BNT314 per cohort

Secondary Endpoints
Geometric means of area under the concentration-time curve from pre-dose to last quantifiable time point prior to the next dose (AUClast)
from pre-dose to 21 days after study treatment for Cycle 1 and Cycle 2
Geometric means of area under the concentration-time curve from pre-dose to the end of the dosing period (AUCtau)
from pre-dose to 21 days after study treatment for Cycle 1 and Cycle 2
Geometric means of maximum concentration (Cmax) from pre-dose to the end of the dosing period
from pre-dose to 21 days after study treatment for Cycle 1 and Cycle 2
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
BNT314 MonotherapyEXPERIMENTALEscalating dose levels and backfill cohorts
Interventions
NameTypeDescription
BNT314BIOLOGICALIntravenous infusion
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites14

Inclusion Criteria: 1. Have the ability to voluntarily give informed consent by signing and dating the informed consent form (ICF) before initiation of any study-specific procedures. 2. Are willing and able to comply with scheduled visits, treatment schedule, laboratory tests, lifestyle restriction...

Countries:United StatesBelgiumDenmarkJapanSpainUnited Kingdom
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06150183primaryCompletionDate: changed
LOWMay 24, 2026NCT06150183studyFirstPostDate: changed