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New combo therapy targets hard-to-treat breast cancers

NCT ID NCT06827236

Disease control Sponsor: BioNTech SE Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 18, 2026 · Updated 6 times

Summary

This study tests two experimental drugs, BNT323 and BNT327, together in people with advanced breast cancer that has spread or cannot be removed. The goal is to see if the combination can shrink tumors and control the disease. About 380 adults with various types of breast cancer (including HER2-positive, HER2-low, and triple-negative) will take part. The study is in early phases (1 and 2) to find the best dose and check safety.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 380 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2025

Expected to finish

Aug 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria (applicable to all participants and all parts unless otherwise specified): * Have pathologically documented BC that: * Is locally advanced, unresectable or metastatic. * Has a confirmed HER2 status as determined by the local laboratory as standard of care testing prior to study screening (Part 1, Part 2 Cohorts 2 and 4) or the central laboratory (Part 2, Cohorts 1 and 3) from the most recently collected pre-randomization tumor sample. * Has a documented history of HER2 expression consistent with the subgroup definitions (i.e., HER2-low, HER2-ultralow, HER2-null, HER2-positive, or TNBC) as per current American Society of Clinical Oncology/College of American Pathologists guidelines. * Have measurable disease defined by RECIST v1.1. * Has left ventricular ejection fraction ≥55% by either echocardiography or multi-gated acquisition (scanning) within 28 days before randomization/enrollment. Key Exclusion Criteria: * Have history of small bowel obstruction requiring hospitalization within the past 3 months prior to the first dose of IMP. * Have an uncontrolled intercurrent illness that would limit compliance with study requirement or substantially increase risk of incurring adverse events. * Have clinically uncontrolled pleural effusion, ascites or pericardial effusion requiring drainage, peritoneal shunt, or cell-free concentrated ascites reinfusion therapy within 2 weeks prior to randomization/enrollment. * Have a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids, have current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening. * Had prior treatment with topoisomerase I inhibitors, including antibody-drug conjugates with topoisomerase I inhibitor payloads such as trastuzumab deruxtecan. * Have received any of the following therapies or drugs prior to the initiation of the study: * Participants who have received prior treatment with BNT323. * Participants who received prior treatment with a programmed death-ligand 1 (PD-L1) / vascular endothelial growth factor (VEGF) bispecific antibody. Note: Prior treatment with programmed death 1 (PD-1)/VEGF bispecific antibodies, PD-1/PD-L1 inhibitors or anti-VEGF therapies are permitted. * Have received other systemic immunostimulatory agents or immunosuppressive therapies (such as interferon-α, interleukin-2, or methotrexate) within 4 weeks prior to the initiation of study treatment or are within five half-lives of the treatment drug (whichever is longer). Exception: excluding local, intranasal, intraocular, intra-articular or inhaled corticosteroids, short term use (≤7 days) of corticosteroids for prophylaxis (e.g., prevention of contrast agent allergy) or treatment of non-autoimmune conditions (e.g., delayed hypersensitivity reactions caused by exposure to allergens). * Have received systemic corticosteroids (at a dosage greater than 10 mg/day of prednisone or an equivalent dose of other corticosteroids) within 3 weeks prior to the initiation of study treatment. NOTE: Other protocol defined Inclusion/Exclusion criteria apply.

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Conditions

The condition(s) this trial relates to.

breast cancer breast carcinoma breast neoplasm HER2 positive breast carcinoma Her2-receptor negative breast cancer hormone receptor-positive breast cancer invasive breast carcinoma triple-negative breast carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Locally advanced breast cancer Metastatic breast cancer Unresectable breast carcinoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    79 sites in 11 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Adana City Hospital

    RECRUITING

    Adana, 01230, Turkey (Türkiye)

  • Addenbrooke s Hospital

    RECRUITING

    Cambridge, CB2 0QQ, United Kingdom

  • Ankara City Hospital

    RECRUITING

    Ankara, 06800, Turkey (Türkiye)

  • Azienda Ospedaliera Universitaria Policlinico Sant Orsola Malpighi IRCCS

    RECRUITING

    Bologna, 40138, Italy

  • BC Cancer - Vancouver

    RECRUITING

    Vancouver, V5Z 4E6, Canada

  • Baylor Scott & White Research Institute -Texas Oncology

    RECRUITING

    Dallas, Texas, 75246, United States

  • Beth Israel Comprehensive Cancer Center

    RECRUITING

    New York, New York, 10011, United States

  • Beverly Hills Cancer Center

    RECRUITING

    Beverly Hills, California, 90211, United States

  • Box Hill Hospital

    RECRUITING

    Box Hill, 3128, Australia

  • Brigitte Harris Cancer Pavilion BHCP

    RECRUITING

    Detroit, Michigan, 48202, United States

  • CHU Besançon - Hôpital Jean Minjoz

    RECRUITING

    Besançon, 25000, France

  • CIUSSS du Saguenay-Lac-Saint-Jean

    RECRUITING

    Chicoutimi, G7H 5H6, Canada

  • Cancer Research SA

    RECRUITING

    Adelaide, 5000, Australia

  • Centro Integral Oncologico Clara Campal

    RECRUITING

    Madrid, 28050, Spain

  • Clinique Victor Hugo - Centre Jean Bernard

    RECRUITING

    Le Mans, 72000, France

  • Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

    RECRUITING

    Ankara, 06200, Turkey (Türkiye)

  • Ege University Medical Faculty

    RECRUITING

    Izmir, 35100, Turkey (Türkiye)

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    RECRUITING

    Roma, 00168, Italy

  • Fudan University Shanghai Cancer

    RECRUITING

    Shanghai, 201315, China

  • Guangxi Medical University Affiliated Tumor Hospital

    RECRUITING

    Nanning, 530021, China

  • Hacettepe University Medical Faculty

    RECRUITING

    Ankara, 06100, Turkey (Türkiye)

  • Hematology - Oncology Associates of the Treasure Coast

    RECRUITING

    Port Saint Lucie, Florida, 34952, United States

  • Hoag Memorial Hospital Presbyterian

    RECRUITING

    Newport Beach, California, 92663, United States

  • Hospital Clinic de Barcelona

    RECRUITING

    Barcelona, 08036, Spain

  • Hospital HM Nou Delfos

    RECRUITING

    Barcelona, 08023, Spain

  • Hospital Universitari Dexeus

    RECRUITING

    Barcelona, 08028, Spain

  • Huizhou First Hospital

    RECRUITING

    Huizhou, 516003, China

  • IAU Medical Park Florya Hospital

    RECRUITING

    Istanbul, 34295, Turkey (Türkiye)

  • ICO - Site René Gauducheau

    RECRUITING

    Saint-Herblain, 44800, France

  • IEO Istituto Europeo di Oncologia

    RECRUITING

    Milan, 20141, Italy

  • Icahn School of Medicine at Mount Sinai PRIME

    RECRUITING

    New York, New York, 10029-6503, United States

  • Institut Claudius Regaud

    RECRUITING

    Toulouse, 31059, France

  • Institute of Oncology Arensia Exploratory Medicine

    RECRUITING

    Chisinau, 2025, Moldova

  • Istituto Nazionale Tumori Fondazione G. Pascale

    RECRUITING

    Naples, 80131, Italy

  • Istituto Nazionale per la Ricerca sul Cancro di Genova

    RECRUITING

    Genova, 16132, Italy

  • Jilin Cancer Hospital

    RECRUITING

    Changchun, 130000, China

  • Karmanos Cancer Institute

    RECRUITING

    Detroit, Michigan, 48201, United States

  • Koc University Hospital

    RECRUITING

    Istanbul, 34010, Turkey (Türkiye)

  • Konya Necmettin Erbakan University Meram Medical Faculty

    RECRUITING

    Konya, 42080, Turkey (Türkiye)

  • LLC Arensia Exploratory Medicine

    RECRUITING

    Tbilisi, 0112, Georgia

  • London Health Sciences Centre (LHSC) - Victoria Hospital

    RECRUITING

    London, N6A 5W9, Canada

  • MD Anderson Cancer Centre

    RECRUITING

    Madrid, 28033, Spain

  • Medical Park Seyhan Hospital

    RECRUITING

    Adana, 01140, Turkey (Türkiye)

  • Memorial Sloan Kettering Cancer Center Basking Ridge

    RECRUITING

    Basking Ridge, New Jersey, 07920, United States

  • Memorial Sloan Kettering Cancer Center Bergen

    RECRUITING

    Montvale, New Jersey, 07645, United States

  • Memorial Sloan Kettering Cancer Center Monmouth

    RECRUITING

    Middletown, New Jersey, 07748, United States

  • Memorial Sloan Kettering Cancer Center Nassau

    RECRUITING

    Uniondale, New York, 11553, United States

  • Memorial Sloan Kettering Cancer Center Westchester

    RECRUITING

    Harrison, New York, 10604, United States

  • Memorial Sloan Kettering Commack

    RECRUITING

    New York, New York, 11725, United States

  • Memorial Sloan Kettering Hospital

    RECRUITING

    New York, New York, 10065, United States

  • Mersin City Education and Research Hospital

    RECRUITING

    Mersin, 33240, Turkey (Türkiye)

  • Mount Sinai Medical Center

    RECRUITING

    New York, New York, 10019, United States

  • NEXT Barcelona

    RECRUITING

    Barcelona, 08023, Spain

  • NEXT Madrid

    RECRUITING

    Pozuelo de Alarcón, 28223, Spain

  • Royal Free Hospital

    RECRUITING

    London, NW3 2QG, United Kingdom

  • Royal Marsden Hospital

    RECRUITING

    London, SW36JJ, United Kingdom

  • Royal Marsden Hospital-Sutton

    RECRUITING

    Sutton, SM2 5PT, United Kingdom

  • SCRI Oncology Partners

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • START Midwest, LLC

    RECRUITING

    Grand Rapids, Michigan, 49546, United States

  • Saint Luke's Hospital of Kansas City

    RECRUITING

    Kansas City, Missouri, 64111, United States

  • Sichuan Cancer Hospital

    RECRUITING

    Chengdu, 610041, China

  • Sichuan Provincial People's Hospital

    RECRUITING

    Chengdu, 610072, China

  • South Texas Accelerated Research Therapeutics (START), LLC

    RECRUITING

    San Antonio, Texas, 78229, United States

  • St James's University Hospital

    RECRUITING

    Leeds, LS9 7TF, United Kingdom

  • St Vincent s Hospital Melbourne

    RECRUITING

    Fitzroy, 3065, Australia

  • Stony Brook University Hospital

    RECRUITING

    Stony Brook, New York, 11794, United States

  • Summit Medical Group

    RECRUITING

    Florham Park, New Jersey, 07932, United States

  • Sunnybrook Health Sciences Centre

    RECRUITING

    Toronto, M4N 3M5, Canada

  • The Christie Hospital

    RECRUITING

    Manchester, M20 4BX, United Kingdom

  • The First Affiliated Hospital of Bengbu Medical College

    RECRUITING

    Bengbu, 233004, China

  • The First Affiliated Hospital of Chongqing Medical University

    RECRUITING

    Chongqing, 400016, China

  • The Second Affiliated Hospital of Xi an Jiaotong University

    RECRUITING

    Xi'an, 710004, China

  • UT Southwestern Medical Center

    RECRUITING

    Dallas, Texas, 75390-8896, United States

  • University Cancer & Blood Center, LLC

    RECRUITING

    Athens, Georgia, 30607, United States

  • University of Illinois Hospital & Health Sciences System

    RECRUITING

    Chicago, Illinois, 60612, United States

  • Velindre Cancer Centre

    RECRUITING

    Cardiff, CF14 2TL, United Kingdom

  • Washington University School of Medicine

    RECRUITING

    St Louis, Missouri, 63110, United States

  • Winship Cancer Institute of Emory University

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Yeditepe Universitesi Kosuyolu Hastanesi

    RECRUITING

    Istanbul, 31755, Turkey (Türkiye)

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