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BNT329

Phase 1

Advanced Solid Cancers | Small molecule | Oncology |BioNTech SE|Last Updated: May 13, 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
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment245
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07186842A Clinical Trial to Test if the Investigational Drug BNT329 is Safe and Potentially Beneficial for People With Advanced Solid Tumors Known to Express the Tumor Marker CA19-9PHASE1 RECRUITING 245 — — Nov 18, 2025May 1, 2030May 13, 202610 United States, Germany +2
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Study Endpoints
Primary Endpoints
Parts A, B, and C - Occurrence of dose-limiting toxicities within a participant
First 21 days (Part A) or 28 days (Part B) after the first dose of BNT329.

Per dose level/cohort.

All parts - Occurrence of treatment-emergent adverse events (TEAEs), Grade ≥3 TEAEs, serious adverse events (SAEs), treatment-related TEAEs, treatment-related Grade ≥3 TEAEs, and treatment-related SAEs
From first dose of BNT329 until 60 days after the last dose of BNT329 (up to 26 months).

Per dose level/cohort/arm.

All parts - Occurrence of dose interruptions, reductions, and discontinuation of BNT329 due to TEAEs
From the time of initiation of the first dose of BNT329 until 60 days after the last dose of BNT329 (up to 26 months).

Per dose level/cohort/arm.

Part D - Objective response rate (ORR)
From first dose of BNT329 until end of study (up to approximately 36 months).

Per dose level/arm. Defined as the proportion of participants in whom a confirmed complete response (CR) or partial response (PR) (based on the investigator's assessment) is observed as best overall response.

Secondary Endpoints
All parts - Assessment of area under the curve derived from serum concentrations of CA19-9-unbound ADC, CA19-9-unbound total anti-CA19-9 antibody, and unconjugated YL0010014 payload
First 21 days (Part A) or 28 days (Part B) after the first dose of BNT329.
All parts - Assessment of maximum concentration derived from serum concentrations of CA19-9-unbound ADC, CA19-9-unbound total anti-CA19 antibody, and unconjugated YL0010014 payload
First 21 days (Part A) or 28 days (Part B) after the first dose of BNT329.
All parts - Assessment of time to reach maximum concentration derived from serum concentrations of CA19-9-unbound ADC, CA19-9-unbound total anti-CA19-9 antibody, and unconjugated YL0010014 payload
First 21 days (Part A) or 28 days (Part B) after the first dose of BNT329.
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Dose Escalation - Part AEXPERIMENTALBNT329 administered once every 3 weeks at protocol-defined dose levels
Dose Escalation - Part BEXPERIMENTALBNT329 administered once every 2 weeks at protocol-defined dose levels
Dose Escalation: Part CEXPERIMENTALBNT329 administered after pre-dosing with a CA19-9 targeting monoclonal antibody
Dose Expansion - Part DEXPERIMENTALParticipants will be randomized to one of two arms evaluating two different doses as selected from Parts A, B, and C
Interventions
NameTypeDescription
BNT329DRUGIntravenous (IV) infusion
CA19-9-targeting monoclonal antibodyDRUGMonoclonal antibody
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites10

Key Inclusion Criteria All participants and parts: * Have an ECOG PS of 0 to 1 * Have measurable disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1), except for ovarian cancer where participants will be evaluated according to Gynecologic Cancer InterGroup criteria. * ...

Countries:United StatesGermanySpainUnited Kingdom
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT07186842primaryCompletionDate: changed
LOWMay 24, 2026NCT07186842studyFirstPostDate: changed