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
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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).
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Potwierdzony patologicznie rak piersi, miejscowo zaawansowany, nieoperacyjny lub przerzutowy
- •Potwierdzony status HER2 zgodny z definicją podgrupy badania
- •Mierzalna choroba
- •Prawidłowa funkcja serca (frakcja wyrzutowa ≥55%)
✗ Disqualifies
- •Niedrożność jelita cienkiego wymagająca hospitalizacji w ciągu ostatnich 3 miesięcy
- •Niekontrolowana choroba współistniejąca zwiększająca ryzyko działań niepożądanych
- •Niekontrolowany płyn w opłucnej, otrzewnej lub osierdziu
- •Śródmiąższowa choroba płuc w wywiadzie lub obecnie
- •Wcześniejsze leczenie inhibitorem topoizomerazy I
- •Wcześniejsze leczenie podobnym lekiem badanym lub przeciwciałem bispecyficznym PD-L1/VEGF
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- July 21, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (68)
Beverly Hills Cancer Center
Beverly Hills, United States
Hoag Memorial Hospital Presbyterian
Newport Beach, United States
Hematology - Oncology Associates of the Treasure Coast
Port Saint Lucie, United States
University Cancer & Blood Center, LLC
Athens, United States
Winship Cancer Institute of Emory University
Atlanta, United States
University of Illinois Hospital & Health Sciences System
Chicago, United States
Brigitte Harris Cancer Pavilion BHCP
Detroit, United States
START Midwest, LLC
Grand Rapids, United States
Saint Luke's Hospital of Kansas City
Kansas City, United States
Washington University School of Medicine
St Louis, United States
Memorial Sloan Kettering Cancer Center Basking Ridge
Basking Ridge, United States
Summit Medical Group
Florham Park, United States
Memorial Sloan Kettering Cancer Center Monmouth
Middletown, United States
Memorial Sloan Kettering Cancer Center Bergen
Montvale, United States
Memorial Sloan Kettering Cancer Center Westchester
Harrison, United States
Beth Israel Comprehensive Cancer Center
New York, United States
Mount Sinai Medical Center
New York, United States
Icahn School of Medicine at Mount Sinai PRIME
New York, United States
Memorial Sloan Kettering Hospital
New York, United States
Memorial Sloan Kettering Commack
New York, United States
Stony Brook University Hospital
Stony Brook, United States
Memorial Sloan Kettering Cancer Center Nassau
Uniondale, United States
SCRI Oncology Partners
Nashville, United States
Baylor Scott & White Research Institute -Texas Oncology
Dallas, United States
South Texas Accelerated Research Therapeutics (START), LLC
San Antonio, United States
Cancer Research SA
Adelaide, Australia
Sunnybrook Health Sciences Centre
Toronto, Canada
The First Affiliated Hospital of Bengbu Medical College
Bengbu, China
Jilin Cancer Hospital
Changchun, China
Sichuan Cancer Hospital
Chengdu, China
Sichuan Provincial People's Hospital
Chengdu, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, China
Huizhou First Hospital
Huizhou, China
Guangxi Medical University Affiliated Tumor Hospital
Nanning, China
Fudan University Shanghai Cancer
Shanghai, China
The Second Affiliated Hospital of Xi an Jiaotong University
Xi'an, China
Clinique Victor Hugo - Centre Jean Bernard
Le Mans, France
ICO - Site René Gauducheau
Saint-Herblain, France
Institut Claudius Regaud
Toulouse, France
LLC Arensia Exploratory Medicine
Tbilisi, Georgia
Azienda Ospedaliera Universitaria Policlinico Sant Orsola Malpighi IRCCS
Bologna, Italy
IEO Istituto Europeo di Oncologia
Milan, Italy
Istituto Nazionale Tumori Fondazione G. Pascale
Naples, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, Italy
Institute of Oncology Arensia Exploratory Medicine
Chisinau, Moldova
Hospital HM Nou Delfos
Barcelona, Spain
NEXT Barcelona
Barcelona, Spain
Hospital Clinic de Barcelona
Barcelona, Spain
MD Anderson Cancer Centre
Madrid, Spain
Centro Integral Oncologico Clara Campal
Madrid, Spain
NEXT Madrid
Pozuelo de Alarcón, Spain
Medical Park Seyhan Hospital
Adana, Turkey (Türkiye)
Adana City Hospital
Adana, Turkey (Türkiye)
Hacettepe University Medical Faculty
Ankara, Turkey (Türkiye)
Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
Ankara, Turkey (Türkiye)
Ankara City Hospital
Ankara, Turkey (Türkiye)
Yeditepe Universitesi Kosuyolu Hastanesi
Istanbul, Turkey (Türkiye)
Koc University Hospital
Istanbul, Turkey (Türkiye)
IAU Medical Park Florya Hospital
Istanbul, Turkey (Türkiye)
Konya Necmettin Erbakan University Meram Medical Faculty
Konya, Turkey (Türkiye)
Mersin City Education and Research Hospital
Mersin, Turkey (Türkiye)
Addenbrooke s Hospital
Cambridge, United Kingdom
Velindre Cancer Centre
Cardiff, United Kingdom
St James's University Hospital
Leeds, United Kingdom
Royal Free Hospital
London, United Kingdom
Royal Marsden Hospital
London, United Kingdom
The Christie Hospital
Manchester, United Kingdom
Royal Marsden Hospital-Sutton
Sutton, United Kingdom
Trial contact
BioNTech clinical trials patient information
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/1/2026.
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