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Locally Advanced Breast CancerPhase 1/2NCT06827236

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

A Phase 1/2 study testing BNT323 and BNT327 in people with Locally Advanced Breast Cancer and Unresectable Breast Carcinoma, run by BioNTech SE at 81 sites in 11 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This is a Phase I/II, multi-site, open-label, two-part study designed to evaluate the efficacy, safety, optimized dose and contribution of components of BNT323 (also known as trastuzumab pamirtecan and DB-1303) in combination with BNT327 (also known as pumitamig and PM8002) in participants with hormone… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
BNT323 and BNT327
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
380 participants
Where
81 sitesin 11 countries
Study dates
23 Apr 2025to Aug 2029
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • 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:
Show all 11Show fewer
  • 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.

Trial locations and contacts

81 sites in 11 countries. Contact the study team or a site near you to ask about taking part.

BioNTech clinical trials patient information contact

+49 6131 9084 ext. 0

patients@biontech.de

81 sites in 11 countries

United States28 sites, 28 recruiting

  • University Cancer & Blood Center, LLC

    Athens, Georgia, 30607

    Recruiting

  • Winship Cancer Institute of Emory University

    Atlanta, Georgia, 30322

    Recruiting

  • Memorial Sloan Kettering Cancer Center Basking Ridge

    Basking Ridge, New Jersey, 07920

    Recruiting

  • Beverly Hills Cancer Center

    Beverly Hills, California, 90211

    Recruiting

  • University of Illinois Hospital & Health Sciences System

    Chicago, Illinois, 60612

    Recruiting

  • Baylor Scott & White Research Institute -Texas Oncology

    Dallas, Texas, 75246

    Recruiting

  • UT Southwestern Medical Center

    Dallas, Texas, 75390-8896

    Recruiting

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

    Recruiting

  • Brigitte Harris Cancer Pavilion BHCP

    Detroit, Michigan, 48202

    Recruiting

  • Summit Medical Group

    Florham Park, New Jersey, 07932

    Recruiting

  • START Midwest, LLC

    Grand Rapids, Michigan, 49546

    Recruiting

  • Memorial Sloan Kettering Cancer Center Westchester

    Harrison, New York, 10604

    Recruiting

  • Saint Luke's Hospital of Kansas City

    Kansas City, Missouri, 64111

    Recruiting

  • Memorial Sloan Kettering Cancer Center Monmouth

    Middletown, New Jersey, 07748

    Recruiting

  • Memorial Sloan Kettering Cancer Center Bergen

    Montvale, New Jersey, 07645

    Recruiting

  • Greco Hainsworth Center for Research Tennessee Oncology

    Nashville, Tennessee, 37203

    Recruiting

  • SCRI Oncology Partners

    Nashville, Tennessee, 37203

    Recruiting

  • Beth Israel Comprehensive Cancer Center

    New York, New York, 10011

    Recruiting

  • Mount Sinai Medical Center

    New York, New York, 10019

    Recruiting

  • Icahn School of Medicine at Mount Sinai PRIME

    New York, New York, 10029-6503

    Recruiting

  • Memorial Sloan Kettering Hospital

    New York, New York, 10065

    Recruiting

  • Memorial Sloan Kettering Commack

    New York, New York, 11725

    Recruiting

  • Hoag Memorial Hospital Presbyterian

    Newport Beach, California, 92663

    Recruiting

  • Hematology - Oncology Associates of the Treasure Coast

    Port Saint Lucie, Florida, 34952

    Recruiting

  • South Texas Accelerated Research Therapeutics (START), LLC

    San Antonio, Texas, 78229

    Recruiting

  • Washington University School of Medicine

    St Louis, Missouri, 63110

    Recruiting

  • Stony Brook University Hospital

    Stony Brook, New York, 11794

    Recruiting

  • Memorial Sloan Kettering Cancer Center Nassau

    Uniondale, New York, 11553

    Recruiting

Other trials in United States

Turkey (Türkiye)11 sites, 11 recruiting

  • Medical Park Seyhan Hospital

    Adana, 01140

    Recruiting

  • Adana City Hospital

    Adana, 01230

    Recruiting

  • Hacettepe University Medical Faculty

    Ankara, 06100

    Recruiting

  • Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

    Ankara, 06200

    Recruiting

  • Ankara City Hospital

    Ankara, 06800

    Recruiting

  • Yeditepe Universitesi Kosuyolu Hastanesi

    Istanbul, 31755

    Recruiting

  • Koc University Hospital

    Istanbul, 34010

    Recruiting

  • IAU Medical Park Florya Hospital

    Istanbul, 34295

    Recruiting

  • Ege University Medical Faculty

    Izmir, 35100

    Recruiting

  • Konya Necmettin Erbakan University Meram Medical Faculty

    Konya, 42080

    Recruiting

  • Mersin City Education and Research Hospital

    Mersin, 33240

    Recruiting

Other trials in Turkey (Türkiye)

China9 sites, 9 recruiting

  • The First Affiliated Hospital of Bengbu Medical College

    Bengbu, 233004

    Recruiting

  • Jilin Cancer Hospital

    Changchun, 130000

    Recruiting

  • Sichuan Cancer Hospital

    Chengdu, 610041

    Recruiting

  • Sichuan Provincial People's Hospital

    Chengdu, 610072

    Recruiting

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, 400016

    Recruiting

  • Huizhou First Hospital

    Huizhou, 516003

    Recruiting

  • Guangxi Medical University Affiliated Tumor Hospital

    Nanning, 530021

    Recruiting

  • Fudan University Shanghai Cancer

    Shanghai, 201315

    Recruiting

  • The Second Affiliated Hospital of Xi an Jiaotong University

    Xi'an, 710004

    Recruiting

Other trials in China

Spain7 sites, 7 recruiting

  • Hospital HM Nou Delfos

    Barcelona, 08023

    Recruiting

  • NEXT Barcelona

    Barcelona, 08023

    Recruiting

  • Hospital Universitari Dexeus

    Barcelona, 08028

    Recruiting

  • Hospital Clinic de Barcelona

    Barcelona, 08036

    Recruiting

  • MD Anderson Cancer Centre

    Madrid, 28033

    Recruiting

  • Centro Integral Oncologico Clara Campal

    Madrid, 28050

    Recruiting

  • NEXT Madrid

    Pozuelo de Alarcón, 28223

    Recruiting

Other trials in Spain

United Kingdom7 sites, 7 recruiting

  • Addenbrooke s Hospital

    Cambridge, CB2 0QQ

    Recruiting

  • Velindre Cancer Centre

    Cardiff, CF14 2TL

    Recruiting

  • St James's University Hospital

    Leeds, LS9 7TF

    Recruiting

  • Royal Free Hospital

    London, NW3 2QG

    Recruiting

  • Royal Marsden Hospital

    London, SW36JJ

    Recruiting

  • The Christie Hospital

    Manchester, M20 4BX

    Recruiting

  • Royal Marsden Hospital-Sutton

    Sutton, SM2 5PT

    Recruiting

Other trials in United Kingdom

Italy5 sites, 5 recruiting

  • Azienda Ospedaliera Universitaria Policlinico Sant Orsola Malpighi IRCCS

    Bologna, 40138

    Recruiting

  • Istituto Nazionale per la Ricerca sul Cancro di Genova

    Genova, 16132

    Recruiting

  • IEO Istituto Europeo di Oncologia

    Milan, 20141

    Recruiting

  • Istituto Nazionale Tumori Fondazione G. Pascale

    Naples, 80131

    Recruiting

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Roma, 00168

    Recruiting

Other trials in Italy

Australia4 sites, 4 recruiting

  • Cancer Research SA

    Adelaide, 5000

    Recruiting

  • Box Hill Hospital

    Box Hill, 3128

    Recruiting

  • St Vincent s Hospital Melbourne

    Fitzroy, 3065

    Recruiting

  • Peter MacCallum Cancer Centre

    Melbourne, 3000

    Recruiting

Other trials in Australia

Canada4 sites, 4 recruiting

  • CIUSSS du Saguenay-Lac-Saint-Jean

    Chicoutimi, G7H 5H6

    Recruiting

  • London Health Sciences Centre (LHSC) - Victoria Hospital

    London, N6A 5W9

    Recruiting

  • Sunnybrook Health Sciences Centre

    Toronto, M4N 3M5

    Recruiting

  • BC Cancer - Vancouver

    Vancouver, V5Z 4E6

    Recruiting

Other trials in Canada

France4 sites, 4 recruiting

  • CHU Besançon - Hôpital Jean Minjoz

    Besançon, 25000

    Recruiting

  • Clinique Victor Hugo - Centre Jean Bernard

    Le Mans, 72000

    Recruiting

  • ICO - Site René Gauducheau

    Saint-Herblain, 44800

    Recruiting

  • Institut Claudius Regaud

    Toulouse, 31059

    Recruiting

Other trials in France

Georgia1 site, 1 recruiting

  • LLC Arensia Exploratory Medicine

    Tbilisi, 0112

    Recruiting

Other trials in Georgia

Moldova1 site, 1 recruiting

  • Institute of Oncology Arensia Exploratory Medicine

    Chisinau, 2025

    Recruiting

Other trials in Moldova

About this study

Official title: A Phase I/II, Multi-site, Open-label, Two-part Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of BNT323 in Combination With BNT327 in Participants With Advanced Breast Cancer

This is a Phase I/II, multi-site, open-label, two-part study designed to evaluate the efficacy, safety, optimized dose and contribution of components of BNT323 (also known as trastuzumab pamirtecan and DB-1303) in combination with BNT327 (also known as pumitamig and PM8002) in participants with hormone receptor-positive (HR+) or hormone receptor-negative (HR-), Human epidermal growth factor receptor (HER)2-positive, HER2-low (immunohistochemistry [IHC] 1+ or IHC 2+/in situ hybridization -), HER2-ultralow (IHC 0, with membrane staining) or HER2-null breast cancer (BC), or triple-negative breast cancer (TNBC).

Read the detailed description

The study consists of two parts:

  • Part 1 - Dose escalation: In this part of the study, participants with histologically confirmed, chemotherapy-pretreated advanced HR+, HER2-low or HER2-ultralow BC will receive BNT323 in combination with BNT327 (BNT323 + BNT327) in a dose escalation design. This will define the recommended Phase 2 dose (RP2D) for the BNT323 + BNT327 combination therapy.
  • Part 2 - Dose optimization and exploratory cohorts: This part of the study will be an expansion phase, aiming to evaluate the efficacy and safety of the optimal dose combination and providing a more robust comparison against the other treatments. It will start once the enrollment in Part 1 is completed and the sponsor in conjunction with the Safety Review Committee has assessed available Part 1 efficacy and safety data. Part 2 of the study will have four cohorts, i.e., Cohorts 1 (dose optimization cohort), and Cohorts 2, 3, and 4 (exploratory cohorts). Recruitment to Cohorts 2, 3, and 4 will begin with RP2D from Part 1 and in parallel to randomization in Cohort 1.

Randomization is planned for Cohort 1 in Part 2, i.e., participants will be randomized in 2:2:1:1 ratio into one of the four arms (Arms 1-4). No randomization is planned for any other cohort in Part 2.

Being tested
BNT323, BNT327
Keywords
Breast Cancer (BC), Human epidermal growth factor receptor 2 (HER2), IHC scores 0, 1+, 2+, and 3+, Antibody drug conjugate (ADC), Programmed Death-1 (PD-1), Programmed Death Ligand-1 (PD-L1), Programmed Death-1 monoclonal antibodies, Anti vascular endothelial growth factor-A (anti-VEGF-A)
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BNT323Drug

    Also called trastuzumab pamirtecan, DB-1303

    Intravenous infusion

  • BNT327Drug

    Also called Pumitamig, PM8002

    Intravenous infusion

Study groups in NCT06827236
Study groupRoleWhat they receive
Part1 - BNT323 + BNT327 combination therapyExperimentalEscalating dose levels (DLs) of BNT323 and BNT327 to define RP2D. Six DLs are planned, i.e., DL0-1, DL1-1, DL2-1, DL0-0, DL1-0, DL2-0, a combination of three different DLs for BNT323 (DL0, DL1, and DL2) and two DLs for BNT327 (DL0 and DL1).
Receives: Drug: BNT323; Drug: BNT327
Part 2 Cohort 1 - Arm 1 - RP2D of BNT323 + BNT327ExperimentalNot described
Receives: Drug: BNT323; Drug: BNT327
Part 2 Cohort 1 - Arm 2 - BNT323 + BNT327ExperimentalNot described
Receives: Drug: BNT323; Drug: BNT327
Part 2 Cohort 1 - Arm 3 - BNT323 monotherapyExperimentalBNT323 monotherapy at a fixed dose
Receives: Drug: BNT323
Part 2 Cohort 1 - Arm 4 - BNT327 monotherapyExperimentalBNT327 monotherapy at a fixed dose
Receives: Drug: BNT327
Part 2 Cohort 2 - RP2D of BNT323 + BNT327ExperimentalNot described
Receives: Drug: BNT323; Drug: BNT327
Part 2 Cohort 3 - RP2D of BNT323 + BNT327ExperimentalNot described
Receives: Drug: BNT323; Drug: BNT327
Part 2 Cohort 4 - RP2D of BNT323 + BNT327ExperimentalNot described
Receives: Drug: BNT323; Drug: BNT327

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part 1 - Occurrence of dose limiting toxicities (DLTs)

    By dose level.

    Measured: During the DLT evaluation period (Cycle 1), i.e., the time of initiation of the first dose of investigational medicinal product (IMP) up to 21 days

  2. Occurrence of Treatment-emergent adverse events (TEAEs), Grade ≥3 TEAEs, serious adverse events (SAEs), treatment-related TEAEs, treatment-related Grade ≥3 TEAEs, and treatment-related SAEs

    In Part 1 by dose level. In Part 2 by cohort and arm.

    Measured: From the time of initiation of the first dose of IMP to 90 days after the last IMP dose

  3. Occurrence of dose interruption, reduction, and discontinuation due to TEAEs

    In Part 1 by dose level. In Part 2 by cohort and arm.

    Measured: From the time of initiation of the first dose of IMP to 90 days after the last IMP dose

  4. Part 2 - Objective response rate (ORR)

    ORR defined as the proportion of participants in whom a confirmed complete response (CR) or partial response (PR) (per Response Evaluation Criteria in Solid Tumors version 1.1 [RECIST v1.1] based on the investigator's assessment) is observed as best overall response.

    By cohort and arm.

    Measured: From the time of initiation of the first dose of IMP to last tumor assessment scan, i.e., up to 36 months.

Secondary outcomes (5)

  1. Part 1 - ORR

    ORR defined as the proportion of participants in whom a confirmed CR or PR (per RECIST v1.1 based on the investigator's assessment) is observed as best overall response.

    By dose level.

    Measured: From the time of initiation of the first dose of IMP to last tumor assessment scan, i.e., up to 36 months.

  2. Part 2 - Duration of response (DoR)

    DoR defined as the time from first objective response (CR or PR per RECIST v1.1 based on the investigator's assessment) to first occurrence of objective tumor progression (progressive disease [PD], per RECIST v1.1 based on the investigator's assessment) or death from any cause, whichever occurs first.

    By cohort and arm.

    Measured: From the time of initiation of the first dose of IMP to last tumor assessment scan, i.e., up to 36 months.

  3. Part 2 - Disease control rate (DCR)

    DCR defined as the proportion of participants with confirmed CR, PR, or stable disease (per RECIST v1.1 based on the investigator's assessment) as best overall response.

    By cohort and arm.

    Measured: From the time of initiation of the first dose of IMP to last tumor assessment scan, i.e., up to 36 months.

  4. Part 2 - Time to response (TTR)

    TTR defined as the time from first dose of IMP to first objective response (CR or PR per RECIST v1.1 based on the investigator's assessment).

    By cohort and arm.

    Measured: From the time of initiation of the first dose of IMP to last tumor assessment scan, i.e., up to 36 months.

  5. Part 2 Cohort 1 only - Progression free survival (PFS)

    PFS based on the investigator's assessment defined as the time from first dose of IMP to the first objective tumor progression (PD per RECIST v1.1) or death from any cause, whichever occurs first.

    By arm.

    Measured: From the time of initiation of the first dose of IMP to last tumor assessment scan, i.e., up to 36 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Feb 2025
  2. Study start23 Apr 2025
  3. Primary completionAug 2029 (estimated)
  4. Study completionAug 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
380 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06827236
Sponsor's protocol ID
BNT323-03
Other IDs
2024-517979-20-00, 1011776
Status last verified
Oct 2026
First submitted
10 Feb 2025
Last updated
15 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing BNT323 and BNT327 in people with Locally Advanced Breast Cancer and Unresectable Breast Carcinoma, run by BioNTech SE at 81 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 81 sites in United States, Turkey (Türkiye), China, Spain, United Kingdom and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact BioNTech clinical trials patient information (+49 6131 9084 ext. 0, patients@biontech.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1 - Occurrence of dose limiting toxicities (DLTs) (time frame: During the DLT evaluation period (Cycle 1), i.e., the time of initiation of the first dose of investigational medicinal product (IMP) up to 21 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06827236.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.

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