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

Endometrial Cancer Clinical Trial

Official title:
A Phase III, Randomized, Multi-site, Open-label Trial of BNT323/DB-1303 Versus Investigator's Choice of Chemotherapy in Previously Treated Patients With HER2- Expressing Recurrent Endometrial Cancer

Clinical Trial Summary

The goal of this clinical study is to assess the efficacy of BNT323/DB-1303 compared with investigator's choice of chemotherapy in terms of progression-free survival (PFS) by blinded independent central review (BICR) in the endometrial cancer population.

Clinical Trial Description

This is an open-label, randomized, multi-site, Phase III, interventional clinical study designed to determine the efficacy and safety of BNT323/DB-1303 compared with investigator's choice of single agent chemotherapy in previously treated patients with recurrent endometrial cancer, whose disease has progressed on at least one line of platinum-based therapy. Owing to the differences in availability of immune checkpoint inhibitors (ICIs) between countries, there will be two cohorts in the study: - Cohort 1 (main cohort): Patients that have had prior ICI treatment. - Cohort 2 (China only): Patients that have not had prior ICI treatment. In each cohort, patients will be randomized 2:1 to receive either BNT323/DB-1303 or investigator's choice of single agent chemotherapy (doxorubicin or paclitaxel) until Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 defined progressive disease (PD) unless there is unacceptable toxicity, withdrawal of consent, or another criterion for discontinuation is met. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06340568
Study type Interventional
Source BioNTech SE
Contact BioNTech clinical trials patient information
Phone +49 6131 9084
Email patients@biontech.de
Status Not yet recruiting
Phase Phase 3
Start date August 2024
Completion date December 2028
View Details
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