A Clinical Study to Test if an Investigational Treatment Called BNT326 is Safe and Potentially Beneficial When Used Alone or in Combination With Other Investigational Treatments Such as BNT327, for People With Advanced Malignant Tumors

NCT07070232 · readout ≤ 590 d

Sponsored by BioNTech SE (industry) · BNTX — their whole pipeline →. With BioNTech (Shanghai) Pharmaceuticals Co., Ltd..

Phase

Phase 1/2

Status

Recruiting

Study type

Interventional

Design

Randomized · None · Treatment

Enrollment

1,438estimated

Sites

Countries

Australia, Belgium, Germany +5

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Dates

each axis at the precision it was filed, with the registry's own basis

Date

Filed

Basis

What it is

Start

2025-08-12

actual

When the study began enrolling

Primary completion

Mar 2028

estimated

The date the last participant is measured for the primary outcome — the readout window

Study completion

Mar 2030

estimated

The whole study's end, after follow-up

First posted

2025-07-17

actual

When this record first appeared on the registry

Results posted

—

When the sponsor posted results to the registry

Record updated

2026-07-22

actual

The sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Condition

Advanced Solid Tumor

Interventions

Drug: BNT326
Drug: Pumitamig — also filed as BNT327, PM8002
Drug: Itraconazole
Drug: Paroxetine

Primary outcomes

what the primary-completion date above is the date OF

Parts 1 and 2 - All cohorts except Cohort 1F - Occurrence of treatment emergent adverse events (TEAEs), treatment related adverse events (TRAEs), treatment emergent serious adverse events (TESAEs), and treatment related serious adverse events (TRSAEs)

measured from first dose of investigational medicinal product (IMP) up to 42 days (Part 1) and 90 days (Part 2) after the last dose of IMP or until a new systemic anti-cancer therapy is started, whichever occurs first (up to 26 months Part 1 or 27 months Part 2)

Parts 1 and 2 - All cohorts except Cohort 1F - Occurrence of dose interruption, reduction, and treatment discontinuations due to TEAEs

measured from first dose of IMP up to 42 days (Part 1) and 90 days (Part 2) after the last dose of IMP or until a new systemic anti-cancer therapy is started, whichever occurs first (up to 26 months Part 1 or 27 months Part 2)

Parts 1 and 2 - All cohorts except Cohort 1F - Confirmed overall response rate (ORR)

measured from the time of initiation of the first dose of IMP up to approximately 38 months (Part 1) and approximately 48 months (Part 2)

Part 2 - Occurrence of dose limiting toxicities (DLTs)

measured from the time of initiation of the first dose of IMP up to 21 days

Part 1 - Cohort 1F (DDI) only - PK assessment: Maximum concentration (Cmax) derived from serum concentrations of BNT326 ADC and unconjugated payload

measured from the time of initiation of the first dose of IMP up to safety follow-up visit, approximately 42 days post last IMP dose

Part 1 - Cohort 1F (DDI) only - PK assessment: Area under the curve (AUC) over the last 17-day dosing interval derived from serum concentrations of BNT326 ADC and unconjugated payload

measured from the time of initiation of the first dose of IMP up to safety follow-up visit, approximately 42 days post last IMP dose

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