A Clinical Study of the Anti-cancer Effects of an Investigational Therapy or Chemotherapy in Patients With Recurring Uterine Cancer

NCT06340568 · readout ≤ 590 d

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

Phase

Phase 3

Status

Recruiting

Study type

Interventional

Design

Randomized · None · Treatment

Enrollment

480estimated

Sites

171

Countries

Argentina, Australia, Belgium +22

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

2025-06-10

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

Nov 2029

estimated

The whole study's end, after follow-up

First posted

2024-04-01

actual

When this record first appeared on the registry

Results posted

—

When the sponsor posted results to the registry

Record updated

2026-07-21

actual

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

What it studies

Condition

Endometrial Cancer

Interventions

Drug: BNT323/DB-1303 — also filed as trastuzumab pamirtecan
Drug: Doxorubicin
Drug: Paclitaxel
Drug: Docetaxel

Primary outcomes

what the primary-completion date above is the date OF

Cohort 1: PFS assessed by blinded independent central review (BICR) in participants with HER2 IHC 1+/2+ recurrent endometrial cancer

measured Up to approximately 53 months

Cohort 2: ORR assessed by BICR in participants with HER2 IHC 3+ recurrent endometrial cancer

measured Up to approximately 53 months

Publications

PMID 40966692 — linked by the registry

Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.

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