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DB-1311/BNT324

Phase 2

Solid Tumors | Small molecule | Oncology |BioNTech SE|Last Updated: May 22, 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 Enrollment450
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06953089DB-1311 in Combination With BNT327 or DB-1305 in Advanced/Metastatic Solid TumorsPHASE2 RECRUITING 450 — — Jul 18, 2025Jun 30, 2030May 22, 202637 United States, Australia +2
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Study Endpoints
Primary Endpoints
Part 1: Number of participants with Dose Limiting Toxicities (DLTs).
During the DLT evaluation period, i.e., the time of initiation of the first dose of investigational medicinal product (IMP) up to 21 days
Part 1: Treatment-emergent adverse events (TEAEs) and treatment-emergent serious AE (TESAEs)
up to follow up period, e.g. up to 72 months.
Part 2: Treatment-emergent adverse events (TEAEs) and treatment-emergent serious AE (TESAEs) [By arm and dose level]
From the time of initiation of the first dose of IMP to end of study, i.e., up to 72 months
Part 2: Objective response rate (ORR), defined as the proportion of participants in whom a confirmed Complete response (CR) or PR is observed as best overall response (per RECIST 1.1 based on the investigator's assessment)by arm and dose level.
From the time of initiation of the first dose of IMP to end of study, i.e., up to 72 months
Secondary Endpoints
Part 1: ORR, defined as the proportion of participants in whom a confirmed CR or PR is observed as best overall response (per RECIST 1.1 based on the investigator's assessment).
From the time of initiation of the first dose of IMP to end of study, i.e., up to 72 months
Part 1 and 2: Duration of response (DoR) per RECIST 1.1 based on the investigator's assessment.
From the time of initiation of the first dose of IMP to end of study, i.e., up to 72 months
Part 1 and 2: Overall survival (OS)
From the time of initiation of the first dose of IMP to end of study, i.e., up to 72 months
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Part 1 Cohort 1A, DB-1311/BNT324+ BNT327 combination therapyEXPERIMENTALEscalating combination dose levels of DB-1311/BNT324 and BNT327 to define RP2D (Recommended Phase 2 Dose) and RP2D-1 in target population.
Part 1 Cohort 2, DB-1311/BNT324+ DB-1305 /BNT325 combination therapyEXPERIMENTALEscalating combination dose levels of DB-1311/BNT324 and DB-1305/BNT325 to define RP2D and RP2D-1 in target population.
Part 2 Arm 1: RP2D of DB-1311/BNT324 + BNT327EXPERIMENTALIn participants with unresectable advanced/metastatic HCC
Part 2 Arm 2: RP2D of DB-1311/BNT324 + BNT327EXPERIMENTALIn participants with unresectable advanced/ metastatic CC
Part2 Arm 3:RP2D of DB-1311/BNT324 + BNT327EXPERIMENTALIn participants with unresectable advanced/metastatic melanoma
Part 2 Arm 4: RP2D of DB-1311/BNT324 + BNT327EXPERIMENTALIn participants with recurrent/metastatic HNSCC
Part 2 Arm 5: RP2D of DB-1311/BNT324 +DB-1305/BNT325 and RP2D-1 of DB-1311/BNT324 +DB-1305/BNT325EXPERIMENTALIn participants with advanced/unresectable metastatic NSCLC
Part 1 Cohort 1B, DB-1311/BNT324+ BNT327 combination therapyEXPERIMENTALEscalating combination dose levels of DB-1311/BNT324 and BNT327 to define RP2D and RP2D-1 in target population.
Part 2 Arm 6: RP2D of DB-1311/BNT324 + BNT327EXPERIMENTALIn participants with unresectable advanced/metastatic PSOC
Part 2 Arm 7: RP2D of DB-1311/BNT324 + BNT327EXPERIMENTALIn participants with unresectable advanced/metastatic PDAC
Part 2 Arm 8: RP2D of DB-1311/BNT324 + BNT327EXPERIMENTALIn participants with unresectable advanced/metastatic breast cancer
Part 2 Arm 9: RP2D of DB-1311/BNT324 + BNT327EXPERIMENTALIn participants with unresectable advanced/metastatic CRC
Part 2 Arm 10: RP2D of DB-1311/BNT324 + BNT327EXPERIMENTALIn participants with unresectable advanced/metastatic mCRPC
Interventions
NameTypeDescription
DB-1311/BNT324DRUGAdministered I.V.
BNT327DRUGAdministered I.V.
DB-1305/BNT325DRUGAdministered I.V.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites37

Inclusion Criteria: * Adults aged ≥ 18 years or acceptable age according to local regulations at the time of voluntarily signing informed consent. * At least one measurable lesion as assessed by the Investigator according to RECIST v1.1 criteria. * Has a life expectancy of ≥ 3 months. * Has an East...

Countries:United StatesAustraliaChinaTaiwan
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Competitive Landscape -Other Solid Tumors 9 trials
CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK2PHASE2pembrolizumab, V503, GARDASIL
Incyte CorporationINCY1PHASE2Chemotherapy, Retifanlimab
Novartis AG Sponsored ADRNVS1PHASE1KFA115, pembrolizumab
Iovance Biotherapeutics IncIOVA2PHASE2E7 TCR-T cells, Aldesleukin
AstraZeneca PLCAZN1 — Trastuzumab deruxtecan
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06953089Enrollment: 492 → 450
LOWMay 24, 2026NCT06953089studyFirstPostDate: changed