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BNT152

Phase 1

Solid Tumor | Small molecule | Oncology |BioNTech SE|Last Updated: Sep 25, 2025

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment86

FDA Designations

No designations recorded

Clinical trial landscape

BNT152 · 1 trial · 1 indication

Phase 1 1
NCT04710043Dose Escalation Trial of BNT152+153 in Patients With CancerSolid Tumor
COMPLETED86 Analytics
PHASE1COMPLETED
Dose Escalation Trial of BNT152+153 in Patients With Cancer
Solid TumorUnlock trial analytics

Study Endpoints

Primary Endpoints

Occurrence of treatment-emergent adverse events (TEAEs) including Grade ≥ 3, serious, fatal TEAE by causal relationship to trial treatment
up to 24 months

TEAEs will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v.5.0.

Occurrence of dose reduction and discontinuation of investigational medicinal product within a patient due to TEAE
up to 24 months
Occurrence of dose limiting toxicities (DLTs) during the DLT evaluation period - BNT152
21 days
Occurrence of DLTs during the DLT evaluation period - BNT153
21 days

Secondary Endpoints

Objective response rate (ORR)
up to 24 months
Disease control rate (DCR)
up to 24 months
Duration of response (DOR)
up to 24 months
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part 1 group A BNT153EXPERIMENTALMonotherapy dose escalation.
Part 1 group B BNT152EXPERIMENTALMonotherapy dose escalation.
Part 2A - BNT152+153EXPERIMENTALEscalating dose levels up to RP2D
Part 2B - BNT152+153EXPERIMENTALEscalating dose levels up to RP2D
Part 2C - BNT152+153EXPERIMENTALEscalating dose levels up to RP2D
Part 2 - BNT152+153 - biomarker cohortEXPERIMENTAL -

Interventions

NameTypeDescription
BNT152DRUGintravenous
BNT153DRUGintravenous
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites7

Inclusion Criteria: * Histologically or cytologically confirmed solid tumor that is metastatic (Stage IV) or unresectable and for whom there is no available standard therapy likely to confer clinical benefit, or patient who is not a candidate for such available therapy. If there is no contraindicat...

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

Frequently asked questions about BNT152

What is BNT152 used for?

BNT152 is an investigational small molecule being developed for the treatment of solid tumors. It is currently in Phase 1 clinical development, meaning it has not yet been approved by regulatory authorities and is still being studied for safety and efficacy in patients.

Who makes BNT152?

BNT152 is being developed by BioNTech SE, a biotechnology company publicly traded under the ticker symbol BNTX. The company is conducting clinical trials to evaluate the drug's potential as a treatment for solid tumors.

What phase is BNT152 in?

BNT152 is in Phase 1 clinical development. A Phase 1 dose escalation trial has been completed, which typically focuses on evaluating the drug's safety, tolerability, and dosing. The drug remains investigational and is not yet approved for commercial use.

What clinical trials is BNT152 in?

BNT152 has been studied in one clinical trial, identified as NCT04710043, titled "Dose Escalation Trial of BNT152+153 in Patients With Cancer." This Phase 1 trial enrolled 86 patients with solid tumors and was conducted in the United States and Czechia. The trial has been completed.

Is BNT152 the same as BNT153?

BNT152 is not the same as BNT153, but the two are being studied together in a combination trial. The completed Phase 1 trial, NCT04710043, evaluated both BNT152 and BNT153 in patients with cancer, suggesting they are distinct agents being tested in combination.