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BNT317 DL1

Phase 1

Advanced Solid Tumor | Monoclonal antibody | Oncology |BioNTech SE|Last Updated: Feb 11, 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
CONTROLLEDBiomarker
Total Trials1
Total Enrollment39
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06750185Safety and Preliminary Effectiveness of BNT317, an Investigational Therapy for Advanced Solid TumorsPHASE1 RECRUITING 39 — — Jan 13, 2025Jun 1, 2028Feb 11, 202611 United States, Australia
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Study Endpoints
Primary Endpoints
Occurrence of DLTs
up to 28 days post IMP 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.

Occurrence of treatment emergent adverse events (TEAEs) and treatment related adverse events (TRAEs)
from first IMP administration up to 100 days after last dose of IMP or until a new anticancer therapy is initiated

Per dose group. Assessed according to (US National Cancer Institute) Common Terminology Criteria for Adverse Events version 5.0, including Grade ≥3, serious, fatal TEAE by relationship.

Occurrence of dose interruption or discontinuation of study treatment due to TEAEs
from first IMP administration up to 14 days after the last dose of IMP

Per dose group.

MTD or the recommended phase two dose (RP2D) of BNT317
For MTD, up to 28 days post IMP administration on Cycle 1 Day 1 or the day before Cycle 3 Day 1, whichever comes earlier (each cycle is 14 days) or, for RP2D, up to 100 days
Secondary Endpoints
Objective Response Rate (ORR)
from first IMP administration up to 100 days after last dose of IMP or until a new anticancer therapy is initiated
Duration of Response (DOR)
from first IMP administration up to 100 days after last dose of IMP or until a new anticancer therapy is initiated
Disease Control Rate (DCR)
from at least 6 weeks after the first IMP 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
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
BNT317 DL1EXPERIMENTALBNT317 monotherapy
BNT317 DL2EXPERIMENTALBNT317 monotherapy
BNT317 DL3EXPERIMENTALBNT317 monotherapy
BNT317 DL4EXPERIMENTALBNT317 monotherapy
BNT317 DL5 (optional, intermediate)EXPERIMENTALBNT317 monotherapy
BNT317 DL6 (optional, intermediate)EXPERIMENTALBNT317 monotherapy
BNT317 DL7 (optional, additional)EXPERIMENTALBNT317 monotherapy
Interventions
NameTypeDescription
BNT317 DL1BIOLOGICALIntravenous infusion
BNT317 DL2BIOLOGICALIntravenous infusion
BNT317 DL3BIOLOGICALIntravenous infusion
BNT317 DL4BIOLOGICALIntravenous infusion
BNT317 DL5 (intermediate)BIOLOGICALIntravenous infusion
BNT317 DL6 (intermediate)BIOLOGICALIntravenous infusion
BNT317 DL7 (additional)BIOLOGICALIntravenous infusion
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites11

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 appropriate. * Have at least one measurable lesion based on RECIST 1.1. Lesions trea...

Countries:United StatesAustralia
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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, 2026NCT06750185primaryCompletionDate: changed
LOWMay 24, 2026NCT06750185studyFirstPostDate: changed