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Be Part of Research - Trial Details - A Clinical Study to Test if an Investigational Treatment Called BNT326 is Safe and Potentially Beneficial When Used Alone or in Combination With Other Investigational Treatments Such as BNT327, for People With Advanced Malignant Tumors
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A Clinical Study to Test if an Investigational Treatment Called BNT326 is Safe and Potentially Beneficial When Used Alone or in Combination With Other Investigational Treatments Such as BNT327, for People With Advanced Malignant Tumors

Recruiting

Open to: ALL

Age: 18.0 - N/A

Birmingham Southampton London Cardiff Sutton Newcastle upon Tyne Manchester London London Liverpool London Glasgow

Medical Conditions

Advanced Solid Tumor

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 will evaluate the safety, efficacy, optimal dose, and pharmacokinetics (PK) of BNT326 as monotherapy (Part 1) and as combination treatment with immunotherapeutic agents (Part 2) in participants with histologically or cytologically confirmed solid tumors that are advanced (i.e., either metastatic or recurrent tumors with no further definitive treatment possible) and/or have relapsed/progressed after prior therapy.

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 2025 Feb 2028

INTERVENTIONAL

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

Intervention Arm Group : Part 1 (Cohort 1A) - BNT326 monotherapy;Part 1 (Cohort 1B) - BNT326 monotherapy;Part 1 (Cohort 1C) - BNT326 monotherapy;Part 1 (Cohort 1D) - BNT326 monotherapy;Part 1 (Cohort 1E) - BNT326 monotherapy;Part 1 (Cohort 1F, DDI) - BNT326 + itraconazole;Part 1 (Cohort 1F, DDI) - BNT326 + paroxetine;Part 1 (Cohort 1G) - BNT326 monotherapy;Part 2 (Cohort 2A) - BNT326 + pumitamig;Part 2 (Cohort 2B) - BNT326 + pumitamig;Part 2 (Cohort 2C) - Optional - BNT326 + pumitamig;Part 2 (Cohort 2D1) - BNT326 monotherapy;Part 2 (Cohort 2D2) - BNT326 + pumitamig;Part 2 (Cohort 2E1) - BNT326 monotherapy;Part 2 (Cohort 2E2) - BNT326 + pumitamig;Part 2 (Cohort 2F) - BNT326 + pumitamig;

Intervention Type : DRUG
Intervention Description : IV infusion

Intervention Arm Group : Part 2 (Cohort 2A) - BNT326 + pumitamig;Part 2 (Cohort 2B) - BNT326 + pumitamig;Part 2 (Cohort 2C) - Optional - BNT326 + pumitamig;Part 2 (Cohort 2D2) - BNT326 + pumitamig;Part 2 (Cohort 2E2) - BNT326 + pumitamig;Part 2 (Cohort 2F) - BNT326 + pumitamig;

Intervention Type : DRUG
Intervention Description : Oral administration

Intervention Arm Group : Part 1 (Cohort 1F, DDI) - BNT326 + itraconazole;

Intervention Type : DRUG
Intervention Description : Oral administration

Intervention Arm Group : Part 1 (Cohort 1F, DDI) - BNT326 + paroxetine;



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.

  • Queen Elizabeth Hospital
    Birmingham
    B15 2TH
  • Southampton General Hospital
    Southampton
    SO16 6YD
  • Royal Free Hospital
    London
    NW3 2QG
  • Velindre Cancer Centre
    Cardiff
    CF14 2TL
  • Royal Marsden Hospital
    Sutton
    SM2 5PT
  • Northern Centre for Cancer Care
    Newcastle upon Tyne
    NE7 7DN
  • The Christie Hospital
    Manchester
    M20 4BX
  • Imperial College London
    London
    W12 0HS
  • University College London Hospitals
    London
    W1T 7HA
  • The Clatterbridge Cancer Centre
    Liverpool
    L7 8YA
  • Royal Marsden Hospital-London
    London
    SW3 6JJ
  • Beatson West of Scotland Cancer Centre
    Glasgow
    G12 0YN

BioNTech clinical trials patient information +49 6131 9084
patients@biontech.de



The study is sponsored by BioNTech SE and is in collaboration with BioNTech (Shanghai) Pharmaceuticals Co., Ltd..



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Read full details for Trial ID: NCT07070232
Last updated 11 March 2026

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