RecruitingPHASE3INTERVENTIONAL

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

This study is investigating a new medication, BNT323 (also called DB-1303), for women with womb cancer that has returned. The study aims to see how well BNT323 works compared to standard chemotherapy options like doxorubicin, paclitaxel, or docetaxel. Researchers are looking at whether BNT323 can help shrink tumours, stop the cancer from growing, and improve how long participants live without the cancer getting worse. The study also tracks side effects, how the body handles the new medicine, and its impact on quality of life. Participants will be grouped based on a specific protein (HER2) found in their cancer cells.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

BioNTech SE

Enrolment target

480

Start

10 Jun 2025

Estimated completion

01 Nov 2029

Endometrial Cancer

What is this study about?

This research is looking for better ways to treat women whose womb cancer (endometrial cancer) has come back after previous treatments. Although current treatments can be very helpful, sometimes the cancer returns, and new options are needed.

The study is testing a new medicine called BNT323, sometimes known as DB-1303. Researchers want to see if BNT323 is more effective than standard chemotherapy drugs like doxorubicin, paclitaxel, or docetaxel, which are commonly used for this type of cancer. The main aim is to find out if BNT323 can stop the cancer from growing for longer or make the tumours shrink. They will also carefully watch for any side effects and understand how the new medicine affects the body overall.

Participants will be divided into two groups based on a protein called HER2 in their cancer cells. One group will compare BNT323 with chemotherapy, especially for those who have already had a type of treatment called an immune checkpoint inhibitor. The other group will look closer at how well BNT323 works by itself on tumours that have high levels of the HER2 protein.

Key takeaways

Targets women with recurrent womb cancer who have had previous treatments.
Compares a new drug (BNT323) against standard chemotherapy options.
Checks how well BNT323 shrinks tumours and stops cancer growth.
Carefully monitors for any side effects of the new treatment.
Participation involves regular hospital visits for treatment and check-ups.
You can discuss with your doctor if this study is suitable for you.

Who may be eligible?

This study is for women aged 18 or older with womb cancer that has returned. Your cancer must have specific levels of a protein called HER2, which will be checked by the study team. You must also have received certain previous treatments, including platinum-based chemotherapy and another type of treatment called an immune checkpoint inhibitor, and your cancer must have grown since then.

To be considered, your cancer needs to be measurable, meaning doctors can see and track its size. You should also be generally well enough to take part in the study, and your doctors will assess your overall health and how active you are. Your medical history will be carefully reviewed to make sure it's safe for you to join.

There are some reasons you might not be able to join. For example, if you're unable to take any of the standard chemotherapy options the study might use, or if you have certain other serious health issues like uncontrolled lung problems, severe fluid build-up, or recent bowel obstructions. The study team will discuss all these details with you.

Quick self-check

Are you a woman aged 18 or over?
Has your womb cancer come back after previous treatment?
Have you already had platinum-based chemotherapy and an immune checkpoint inhibitor?
Is your HER2 protein level within the study's required range (will be tested)?
Are you generally well enough for the study (your doctor will check)?
Do you have a general life expectancy of at least 12 weeks?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you'll first go through a screening period where doctors will confirm if you meet all the requirements. This involves various checks and tests. Once that's done, you'll enter the treatment period. If you're in one part of the study, you'll be randomly assigned to receive either BNT323 or one of the standard chemotherapy drugs. If you're in the other part, you'll receive BNT323 alone. You will receive the treatment until your cancer starts to grow again, or if you experience side effects that are too difficult to manage, or if you decide to stop.

The treatment period is expected to last about 6 months, but this can vary for each person. During this time, you'll have regular visits for check-ups, tests, and to receive your medication. After treatment stops, you'll enter a safety follow-up period to monitor any lingering side effects, followed by an efficacy follow-up to see how the treatment has affected your cancer in the long run. There will also be a long-term survival follow-up, which could last up to 53 months in total from when you started the study. This means you would have regular contact with the study team for an extended period.

Potential risks and benefits

Taking part in this study could potentially offer you access to a new treatment (BNT323) that might be more effective than current options for your womb cancer. However, as with any medical treatment, there are potential risks, including side effects from BNT323 or the standard chemotherapy. The study team will closely monitor you for any side effects and help manage them. You will also have the right to leave the study at any time, for any reason, and this decision will not affect your future medical care.

Locations (156)

MedStar Washington Hospital Center
Washington D.C., United States· Recruiting
Broward Health Medical Center
Fort Lauderdale, United States· Recruiting
The Center of Hope Reno
Reno, United States· Recruiting
NYU Langone Health
New York, United States· Recruiting
Miami Valley Hospital South
Centerville, United States· Recruiting
Ohio State University
Hilliard, United States· Recruiting
Sanford Cancer Center
Sioux Falls, United States· Recruiting
Hospital Británico de Buenos Aires
Buenos Aires, Argentina· Recruiting
Investigaciones CORI S.R.L.
La Rioja, Argentina· Recruiting
Hospital Provincial del Centenario
Rosario, Argentina· Recruiting
Centro Oncológico de Excelencia
San Juan, Argentina· Recruiting
Adelaide Oncology & Haematology
Adelaide, Australia· Recruiting

+144 more sites — see the official record for the full list.

Common questions

What is womb cancer?

Womb cancer, also called endometrial cancer, is a type of cancer that starts in the lining of the womb (uterus). This study focuses on cases where the cancer has returned after initial treatment.

What is HER2?

HER2 is a protein that can be found in some cancer cells. High levels of HER2 can sometimes mean the cancer grows more quickly, but it can also help doctors choose the right treatments.

What does 'randomised' mean in a study?

Being 'randomised' means that a computer or another fair method decides which treatment group you are in. This helps ensure the study results are as unbiased and accurate as possible.

Will I know which treatment I am getting?

Yes, this is an 'open-label' study, which means both you and your doctor will know whether you are receiving BNT323 or standard chemotherapy.

How long will I be in the study?

The treatment part of the study is expected to last around 6 months. However, you will continue to be monitored for safety and how well the treatment worked for a much longer period, possibly up to 53 months in total.

How to find out more

BioNTech clinical trials patient information

patients@biontech.de +49 6131 9084 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.