Early-phase Trial to Assess the Safety and Preliminary Efficacy of BNT3214 in Adults With Advanced Solid Tumors

NCT07455734 · readout ≤ 1,534 d

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

Phase

Phase 1/2

Status

Recruiting

Study type

Interventional

Design

Randomized · None · Treatment

Enrollment

533estimated

Sites

Countries

Australia, China, South Korea +1

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

2026-03-30

actual

When the study began enrolling

Primary completion

Oct 2030

estimated

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

Study completion

Oct 2030

estimated

The whole study's end, after follow-up

First posted

2026-03-06

actual

When this record first appeared on the registry

Results posted

—

When the sponsor posted results to the registry

Record updated

2026-08-13

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 Cancer

Intervention

Drug: BNT3214 — also filed as PM8102

Primary outcomes

what the primary-completion date above is the date OF

All parts - Number and percentage of participants with treatment emergent adverse events (TEAEs)

measured From the time of initiation of the first dose of BNT3214 until 90 days after the last dose of BNT3214

All parts - Number and percentage of participants with dose interruptions, reductions, and discontinuation of BNT3214 due to TEAEs

measured Up to 24 months

Parts A and B only - Number and percentage of participants with dose limiting toxicities (DLTs)

measured From first dose up to 28 days

Part C only - Objective response rate (ORR)

measured Up to 30 months

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