BNT323-01- BNT323/DB-1303 versus investigator’s choice for patients with endometrial cancer
Research type
Research Study
Full 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
IRAS ID
1009905
Contact name
Patricia Andrade
Contact email
Sponsor organisation
BioNTech SE
Eudract number
2023-507525-42
Clinicaltrials.gov Identifier
Research summary
The purpose of this study is to assess how well the study drug (BNT323/DB-1303) works for human epidermal growth factor receptor 2 (HER2) positive endometrial cancer and get information about its safety; to assess how the body handles the study drug and the participant´s quality of life. Additionally, the study aims to develop a companion diagnostic test for HER2 positivity specific to endometrial cancer. Companion diagnostics are used alongside a specific drug or therapy to help doctor determine if a patient is likely to benefit from that treatment.
In this study, the study drug is compared with 2 chemotherapies (doxorubicin and paclitaxel).
The study drug is designed to target the protein HER2. Cancer cells that have higher levels of HER2 can grow quickly, but they are likely to be vulnerable to treatment with drugs that target HER2.
Doxorubicin and paclitaxel are designed to stop or slow down the process of rapidly dividing cells, including cancer cells, from making more copies of themselves.
Eligible participants will be randomised into 2 groups:
• Group 1: The participants in this group will receive the study drug.
• Group 2: The participants in this group will receive either doxorubicin or paclitaxel (as per Investigator´s choice).
This study is sponsored by BioNTech. About 504 participants will be recruited for this study in approximately 20 countries, including up to 23 participants in the United Kingdom.
There are 3 periods in this study: screening, study treatment, and follow-up period.
Participants will receive the study treatment for as long as their cancer does not get worse, unless it is no longer safe for them to continue or if they decide to withdraw from the study. The planned number of visits is 3 times every cycle while they are receiving the study treatment. After the last dose of the study treatment, participants will be followed up regularly for up to 52 months (just under 4.5 years).REC name
West of Scotland REC 1
REC reference
25/WS/0098
Date of REC Opinion
8 Aug 2025
REC opinion
Further Information Favourable Opinion