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BNT317 DL1

Phase 1

Advanced Solid Tumor | Monoclonal antibody | Oncology |BioNTech SE|Last Updated: Feb 11, 2026

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment39

FDA Designations

No designations recorded

Clinical trial landscape

BNT317 DL1 · 1 trial · 1 indication

Phase 1 1
NCT06750185Safety and Preliminary Effectiveness of BNT317, an Investigational Therapy for Advanced Solid TumorsAdvanced Solid Tumor
RECRUITING39 Analytics
PHASE1RECRUITING
Safety and Preliminary Effectiveness of BNT317, an Investigational Therapy for Advanced Solid Tumors
Advanced Solid Tumor
NCT0675018539
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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 to 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 (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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Frequently asked questions about BNT317 DL1

What is BNT317 DL1 used for in Advanced Solid Tumor?

BNT317 DL1 is an investigational monoclonal antibody being developed for the treatment of advanced solid tumors. It is currently in Phase 1 clinical development, with a single active trial evaluating its safety and preliminary effectiveness in patients with advanced solid tumors.

What does BNT317 DL1 target?

BNT317 DL1 is a monoclonal antibody, but its specific molecular target has not been disclosed. The drug is being investigated for its potential role in treating advanced solid tumors, though the exact mechanism of action is not publicly detailed.

Who makes BNT317 DL1?

BNT317 DL1 is being developed by BioNTech SE, a biotechnology company traded on the NASDAQ under the ticker symbol BNTX. The company is conducting a Phase 1 clinical trial to evaluate the drug's safety and preliminary effectiveness in advanced solid tumors.

What phase is BNT317 DL1 in?

BNT317 DL1 is in Phase 1 clinical development. It is an investigational drug, not yet approved by regulatory authorities, and is currently being studied in a single active clinical trial for advanced solid tumors.

What clinical trials is BNT317 DL1 in?

BNT317 DL1 is being studied in one clinical trial, NCT06750185, titled 'Safety and Preliminary Effectiveness of BNT317, an Investigational Therapy for Advanced Solid Tumors.' This Phase 1 trial is recruiting 39 participants with advanced solid tumors in the United States and Australia.

Is BNT317 DL1 the same as BNT317?

BNT317 DL1 appears to be a specific dose level of the investigational drug BNT317, as indicated by the 'DL1' suffix. The clinical trial NCT06750185 evaluates BNT317, and BNT317 DL1 likely refers to the first dose level being tested in that study.