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Be Part of Research - Trial Details - Safety and Preliminary Effectiveness of BNT327, an Investigational Therapy for Breast Cancer, When Given in Combination With Chemotherapy
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Safety and Preliminary Effectiveness of BNT327, an Investigational Therapy for Breast Cancer, When Given in Combination With Chemotherapy

Not Recruiting

Open to: ALL

Age: 18.0 - N/A

London London Cottingham London Leeds Edinburgh

Medical Conditions

Locally Advanced Breast Cancer
Triple Negative Breast Cancer
Metastatic Triple Negative Breast Cancers

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


This study is a Phase II, multi-site, randomized, open-label clinical study to evaluate the safety, efficacy, and pharmacokinetics (PK) of BNT327 at two dose levels in combination with chemotherapeutic agents in the first- and second-line treatment of participants with locally advanced/metastatic triple-negative breast cancer (mTNBC).

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Aug 2024 Aug 2028

Publications

"Biteghe FAN, Mungra N, Malindi Z, Chalomie NET, Stanislas KA, Yasmin-Karim S, Mike Makrigiorgos G, Chipidza FE, Akinrinmade OA, Sridhar S, Barth S, Ngwa W. The Therapeutic Potential of Photoimmunotherapy as a Safe, Effective and Non-Toxic Treatment Option for Superficial Triple Negative Breast Cancer. Cancer Med. 2025 Sep;14(18):e71255. doi: 10.1002/cam4.71255."; "40970572"

INTERVENTIONAL

Intervention Type : DRUG
Intervention Description : Intravenous (IV) infusion

Intervention Arm Group : Cohort 1 Arm 1 - BNT327 DL1 + Nab-paclitaxel;

Intervention Type : DRUG
Intervention Description : IV infusion

Intervention Arm Group : Cohort 1 Arm 2 - BNT327 DL2 + Nab-paclitaxel;

Intervention Type : DRUG
Intervention Description : IV infusion

Intervention Arm Group : Cohort 1 Arm 1 - BNT327 DL1 + Nab-paclitaxel;Cohort 1 Arm 2 - BNT327 DL2 + Nab-paclitaxel;

Intervention Type : DRUG
Intervention Description : IV infusion

Intervention Arm Group : Cohort 2 Arm 2 - BNT327 Equivalent Q3W dose + Gemcitabine + Carboplatin;

Intervention Type : DRUG
Intervention Description : IV infusion

Intervention Arm Group : Cohort 2 Arm 2 - BNT327 Equivalent Q3W dose + Gemcitabine + Carboplatin;

Intervention Type : DRUG
Intervention Description : IV infusion

Intervention Arm Group : Cohort 2 Arm 1 - BNT327 Optimized dose + Paclitaxel;

Intervention Type : DRUG
Intervention Description : IV infusion

Intervention Arm Group : Cohort 2 Arm 3 - BNT327 Equivalent Q3W dose + Eribulin;

Intervention Type : DRUG
Intervention Description : IV infusion

Intervention Arm Group : Cohort 2 Arm 1 - BNT327 Optimized dose + Paclitaxel;

Intervention Type : DRUG
Intervention Description : IV infusion

Intervention Arm Group : Cohort 2 Arm 2 - BNT327 Equivalent Q3W dose + Gemcitabine + Carboplatin;Cohort 2 Arm 3 - BNT327 Equivalent Q3W dose + Eribulin;



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Sarah Cannon Research Institute
    London
    W1G 6AD
  • St Bartholomew's Hospital - Barts Health NHS Trust
    London
    EC1A 7BE
  • Hull and East Yorkshire Hospitals NHS Trust - Castle Hill Hospital
    Cottingham
    HU16 5JQ
  • University College London Hospitals NHS Foundation Trust
    London
    W1T 7HA
  • St James'S University Hospital - Leeds Teaching Hospitals Nhs Trust
    Leeds
    LS9 7TF
  • Edinburgh Cancer Centre-Western General Hospital
    Edinburgh
    EH4 2XU


The study is sponsored by BioNTech SE and is in collaboration with Bristol-Myers Squibb.




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Read full details for Trial ID: NCT06449222
Last updated 23 February 2026

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