RecruitingPHASE1, PHASE2INTERVENTIONAL

A Clinical Study to Find the Optimal Dose of an Investigational Treatment Called BNT323 When Used in Combination With Another Investigational Treatment, BNT327, and to Test if That Combination Treatment is Safe and Beneficial for Patients With Advanced Breast Cancer

This study is looking into two new treatments, BNT323 and BNT327, for advanced breast cancer. It's split into two main parts. The first part aims to find the best and safest dose of these two treatments when given together. The second part will then test this dose in more people to see how well it works and if it's safe. The study is open to people with different types of breast cancer, including those with certain levels of a protein called HER2, and those with triple-negative breast cancer. Researchers want to understand if this new combination can offer a valuable treatment option for individuals living with this condition.

At a glance

Status

Recruiting

Phase

PHASE1, PHASE2

Sponsor

BioNTech SE

Enrolment target

380

Start

23 Apr 2025

Estimated completion

01 May 2029

Locally Advanced Breast Cancer Unresectable Breast Carcinoma Metastatic Breast Cancer

What is this study about?

This study is a clinical trial exploring two new medicines, BNT323 and BNT327, for people living with advanced breast cancer. Advanced breast cancer means the cancer has spread from where it started or cannot be completely removed by surgery. The main aim is to find out the best amount (dose) of BNT323 to give when it's combined with BNT327, and to check if this combination is safe and helps patients get better. Because these are new treatments being tested together, it's really important to find the right balance between how well they work and any side effects.

The study has two main steps. The first step involves a small group of patients who will receive gradually increasing doses of BNT323 along with BNT327. This helps the doctors figure out the safest and most effective dose to use. Once that dose is found, the second step will involve more patients. In this larger group, the team will further test the chosen dose to confirm its safety and see how well it treats the cancer. This step will also compare the new treatment combination against other standard approaches to understand its benefits.

This research is particularly interested in different types of breast cancer. This includes breast cancer where a protein called HER2 is present at various levels (HER2-positive, HER2-low, HER2-ultralow, or HER2-null), and also a type called triple-negative breast cancer. By including these different types, the study hopes to learn if this new treatment combination could be helpful for a wider range of people with advanced breast cancer.

Key takeaways

This study is testing two new treatments together for advanced breast cancer.
It aims to find the safest and most effective dose of the combined treatments.
The study includes different types of breast cancer, including HER2-positive, HER2-low, and triple-negative.
Participation involves regular hospital visits for check-ups and monitoring.
You can stop participating in the study at any time if you wish.

Who may be eligible?

To be considered for this study, you must be at least 18 years old and have advanced breast cancer that your doctors can measure. Your breast cancer must also have been tested for a protein called HER2, and the results should fit into one of the categories the study is looking at (HER2-positive, HER2-low, HER2-ultralow, HER2-null, or triple-negative).

There are also some reasons why you might not be able to join. For example, if you've recently had a serious bowel problem, have other uncontrolled health issues, or untreated fluid build-up in your chest or abdomen, you might not be eligible. Also, if you've had a certain type of lung condition or have previously been treated with similar specific cancer drugs, including BNT323 itself, you wouldn't be able to take part.

Quick self-check

Are you at least 18 years old?
Do you have advanced breast cancer that can be measured by doctors?
Has your breast cancer been tested for HER2 protein levels?
Have you *not* had serious bowel problems requiring hospitalisation in the last 3 months?
Have you *not* had treatment with BNT323 before?
Do you *not* have a history of certain specific lung conditions that needed steroid treatment?

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, the first part involves finding the safest and most effective dose of the new treatments. This means you might start on a lower dose and it could be increased slowly. Once the best dose is found, the second part of the study will involve more people receiving that dose. Some patients in the second part might be randomly chosen to receive different treatments to help compare the new combination. You will have regular visits to the hospital for assessments, which will include blood tests, scans, and other checks to see how you are responding to the treatment and to monitor for any side effects. The total duration of your participation will depend on how you respond to the treatment, but you will be closely followed for a period after your last dose.

Potential risks and benefits

Taking part in any clinical trial involves both potential benefits and risks. You might benefit if the new treatment combination helps to control your cancer more effectively than other available treatments. However, there's always a chance that the treatment might not work for you, or you could experience side effects, some of which may be serious. The research team will explain all known side effects in detail. It's very important to remember that you can always choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (41)

Beverly Hills Cancer Center
Beverly Hills, United States· Recruiting
Hematology - Oncology Associates of the Treasure Coast
Port Saint Lucie, United States· Recruiting
University Cancer & Blood Center, LLC
Athens, United States· Recruiting
Winship Cancer Institute of Emory University
Atlanta, United States· Recruiting
START Midwest, LLC
Grand Rapids, United States· Recruiting
Saint Luke's Hospital of Kansas City
Kansas City, United States· Recruiting
Washington University School of Medicine
St Louis, United States· Recruiting
Summit Medical Group
Florham Park, United States· Recruiting
Memorial Sloan Kettering Hospital
New York, United States· Recruiting
South Texas Accelerated Research Therapeutics (START), LLC
San Antonio, United States· Recruiting
Sunnybrook Health Sciences Centre
Toronto, Canada· Recruiting
The First Affiliated Hospital of Bengbu Medical College
Bengbu, China· Recruiting

+29 more sites — see the official record for the full list.

Common questions

What is 'advanced breast cancer'?

Advanced breast cancer means the cancer has spread beyond the breast or cannot be completely removed by surgery.

What are BNT323 and BNT327?

These are two new medicines being tested in this study to see if they can help treat advanced breast cancer.

What does a 'Phase 1/2 study' mean?

A Phase 1 study focuses on finding a safe dose, and a Phase 2 study then tests how well that dose works and continues to monitor for safety in more people.

Will I know which treatment I'm getting?

Yes, this study is 'open-label', which means both you and your doctors will know which treatment you are receiving.

What is HER2 status?

HER2 is a protein that can be found on breast cancer cells. The study is looking at how the new treatments work for different levels of HER2.

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.