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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

Join a study testing new breast cancer treatments BNT323 and BNT327.

Recruiting
18 years and older
All
Phase 1/2

This study is testing two new treatments, BNT323 and BNT327, to see if they are safe and help people with advanced breast cancer. The study has two parts: Part 1 will find the best dose of the medicine, and Part 2 will see how well it works. Breast cancer is a disease where cells in the breast grow out of control. Some breast cancers are called HER2-positive because they have a lot of a protein called HER2. Others are HER2-low or HER2-null, meaning they have less of this protein.

  • The study is multi-site, so it happens in different places, and participants will be randomly assigned to different groups in Part 2.
  • It’s important to have a certain heart function, measured by a test, to be part of this study.
  • People cannot join if they’ve had certain lung diseases or certain treatments before.

Participants will join if they have advanced breast cancer that can’t be removed by surgery or has spread to other parts. The study will help find the best dose and check if the new treatment is beneficial.

Study details
    Locally Advanced Breast Cancer
    Unresectable Breast Carcinoma
    Metastatic Breast Cancer

NCT06827236

BioNTech SE

17 October 2026

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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