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
Recruiting now · Phase 1/Phase 2
Conditions studied: Locally Advanced Breast Cancer, Unresectable Breast Carcinoma, Metastatic Breast Cancer
In brief
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).
Key facts
- Study ID
- NCT06827236
- Run by
- BioNTech SE
- People needed
- 380
- Starts
- 2025-04-23
- Expected to finish
- 2029-08-01
- Last updated by the study team
- 2026-07-21
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Hoag Memorial Hospital Presbyterian — Newport Beach, California, United States (enrolling)
- Hematology - Oncology Associates of the Treasure Coast — Port Saint Lucie, Florida, United States (enrolling)
- University Cancer & Blood Center, LLC — Athens, Georgia, United States (enrolling)
- Winship Cancer Institute of Emory University — Atlanta, Georgia, United States (enrolling)
- University of Illinois Hospital & Health Sciences System — Chicago, Illinois, United States (enrolling)
- Brigitte Harris Cancer Pavilion BHCP — Detroit, Michigan, United States (enrolling)
- START Midwest, LLC — Grand Rapids, Michigan, United States (enrolling)
- Saint Luke's Hospital of Kansas City — Kansas City, Missouri, United States (enrolling)
- Washington University School of Medicine — St Louis, Missouri, United States (enrolling)
- Memorial Sloan Kettering Cancer Center Basking Ridge — Basking Ridge, New Jersey, United States (enrolling)
- Summit Medical Group — Florham Park, New Jersey, United States (enrolling)
- Memorial Sloan Kettering Cancer Center Monmouth — Middletown, New Jersey, United States (enrolling)
- Memorial Sloan Kettering Cancer Center Bergen — Montvale, New Jersey, United States (enrolling)
- Memorial Sloan Kettering Cancer Center Westchester — Harrison, New York, United States (enrolling)
- Beth Israel Comprehensive Cancer Center — New York, New York, United States (enrolling)
- Mount Sinai Medical Center — New York, New York, United States (enrolling)
- Icahn School of Medicine at Mount Sinai PRIME — New York, New York, United States (enrolling)
- Memorial Sloan Kettering Hospital — New York, New York, United States (enrolling)
- Memorial Sloan Kettering Commack — New York, New York, United States (enrolling)
- Stony Brook University Hospital — Stony Brook, New York, United States (enrolling)
- Memorial Sloan Kettering Cancer Center Nassau — Uniondale, New York, United States (enrolling)
- SCRI Oncology Partners — Nashville, Tennessee, United States (enrolling)
- Baylor Scott & White Research Institute -Texas Oncology — Dallas, Texas, United States (enrolling)
- South Texas Accelerated Research Therapeutics (START), LLC — San Antonio, Texas, United States (enrolling)
- Beverly Hills Cancer Center — Beverly Hills, California, United States (enrolling)
Full record on ClinicalTrials.gov
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