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BNT317

Phase 1

Advanced Solid Tumor | Monoclonal antibody | Oncology |BioNTech SE|Last Updated: Sep 9, 2026

Target and mechanism

ModalityMonoclonal antibody

Also known as BNT317 DL1, BNT317 DL2, BNT317 DL3, BNT317 DL4, BNT317 DL5, BNT317 DL6, BNT317 selected DLA, BNT317 selected DLB

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment248

FDA Designations

No designations recorded

Clinical trial landscape

BNT317 · 1 trial · 1 indication

Phase 1 1
NCT06750185Safety and Preliminary Effectiveness of BNT317, an Investigational Therapy for Advanced Solid TumorsAdvanced Solid Tumor
RECRUITING248 Analytics
PHASE1RECRUITING
Safety and Preliminary Effectiveness of BNT317, an Investigational Therapy for Advanced Solid Tumors
Advanced Solid Tumor
NCT06750185248
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Study Endpoints

Primary Endpoints

Part A - Occurrence of DLTs
Up to 28 days after initiating BNT317 administration on Day 1 of Cycle 1 or the day before Cycle 3 Day 1, whichever comes earlier (each cycle is 14 days)

Per dose group. During the DLT observation period.

All parts - Occurrence of treatment-emergent adverse events (TEAEs), Grade ≥3 TEAEs, serious adverse events (SAEs), treatment-related adverse events (TRAEs), treatment-related Grade ≥3 TEAEs, and treatment-related SAEs
From the first dose of BNT317 up to 100 days after last dose of IMP or until a new anticancer therapy is initiated

Per dose group.

All parts - Occurrence of dose interruption, reductions, and discontinuation of BNT317 due to TEAEs
From the first dose of BNT317 up to 100 days after last dose of IMP or until a new anticancer therapy is initiated

Per dose group.

Parts B1, B2 & B3: Objective Response Rate (ORR)
From the first dose of BNT317 up to 100 days after last dose of IMP or until a new anticancer therapy is initiated

Per dose group. 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

Part A - ORR
From the first dose of BNT317 up to 100 days after last dose of IMP or until a new anticancer therapy is initiated
All parts - Duration of Response
From the first dose of BNT317 up to 100 days after last dose of IMP or until a new anticancer therapy is initiated
All parts - Disease Control Rate
From at least 6 weeks (±7 days) after the first BNT317 dose up to 100 days after last dose of IMP or until a new anticancer therapy is initiated
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part A - BNT317 DL1EXPERIMENTALBNT317 monotherapy
Part A - BNT317 DL2EXPERIMENTALBNT317 monotherapy
Part A - BNT317 DL3EXPERIMENTALBNT317 monotherapy
Part A - BNT317 DL4EXPERIMENTALBNT317 monotherapy
Part A - BNT317 DL5EXPERIMENTALBNT317 monotherapy
Part A - BNT317 DL6 (optional)EXPERIMENTALBNT317 monotherapy
Part B1 - BNT317 selected DLAEXPERIMENTALBNT317 monotherapy, DL as selected from Part A.
Part B1 - BNT317 selected DLBEXPERIMENTALBNT317 monotherapy, DL as selected from Part A.
Part B2 - BNT317 selected DLA plus SoC chemotherapy 1EXPERIMENTALBNT317 combination therapy, DL as selected from Part A.
Part B2 - BNT317 selected DLB plus SoC chemotherapy 1EXPERIMENTALBNT317 combination therapy, DL as selected from Part A.
Part B3 - BNT317 selected DLB plus SoC chemotherapy 2EXPERIMENTALBNT317 combination therapy, DL as selected from Parts B1 and B2.

Interventions

NameTypeDescription
BNT317 DL1BIOLOGICALIntravenous infusion
BNT317 DL2BIOLOGICALIntravenous infusion
BNT317 DL3BIOLOGICALIntravenous infusion
BNT317 DL4BIOLOGICALIntravenous infusion
BNT317 DL5BIOLOGICALIntravenous infusion
BNT317 DL6BIOLOGICALIntravenous infusion
BNT317 selected DLABIOLOGICALIntravenous infusion
BNT317 selected DLBBIOLOGICALIntravenous infusion
SoC chemotherapy 1DRUGIntravenous infusion
SoC chemotherapy 2DRUGIntravenous infusion
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites11

If not specified otherwise, criteria listed below are applicable for all parts. Key Inclusion Criteria: * Have histologically or cytologically confirmed advanced tumors, who have failed standard therapy, or for whom no standard treatment option is available, or for whom standard therapy is not app...

Countries:United StatesAustralia
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Competitive Landscape -Other Solid Tumors 9 trials (matched to "Advanced Solid Tumor")

CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK2PHASE2pembrolizumab
Incyte CorporationINCY1PHASE2Chemotherapy, Retifanlimab
Iovance Biotherapeutics IncIOVA2PHASE2E7 TCR-T cells, Aldesleukin
Novartis AG Sponsored ADRNVS1PHASE1KFA115, pembrolizumab
AstraZeneca PLCAZN1 - Trastuzumab deruxtecan
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Recent Changes (Last 90 Days)

MEDIUMSep 9, 2026NCT06750185Enrollment: 39 → 248
MEDIUMSep 9, 2026NCT06750185Enrollment: 39 → 248