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Study identifier: NCT06827236 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

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

Condition: Locally Advanced Breast Cancer · Unresectable Breast Carcinoma · Metastatic Breast Cancer  ·  Sponsor: BioNTech SE

PhasePhase 1/Phase 2
Planned participants380
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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).

This description comes directly from the study's public registry record.

Talk to the study team

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

Always discuss trial participation with your own doctor first.

Locations (68)

Beverly Hills Cancer CenterBeverly Hills, California, United StatesRecruiting
Hoag Memorial Hospital PresbyterianNewport Beach, California, United StatesRecruiting
Hematology - Oncology Associates of the Treasure CoastPort Saint Lucie, Florida, United StatesRecruiting
University Cancer & Blood Center, LLCAthens, Georgia, United StatesRecruiting
Winship Cancer Institute of Emory UniversityAtlanta, Georgia, United StatesRecruiting
University of Illinois Hospital & Health Sciences SystemChicago, Illinois, United StatesRecruiting
Brigitte Harris Cancer Pavilion BHCPDetroit, Michigan, United StatesRecruiting
START Midwest, LLCGrand Rapids, Michigan, United StatesRecruiting
Saint Luke's Hospital of Kansas CityKansas City, Missouri, United StatesRecruiting
Washington University School of MedicineSt Louis, Missouri, United StatesRecruiting
Memorial Sloan Kettering Cancer Center Basking RidgeBasking Ridge, New Jersey, United StatesRecruiting
Summit Medical GroupFlorham Park, New Jersey, United StatesRecruiting

+ 56 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT06827236