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 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…
Conditions studied
Locally Advanced Breast Cancer, Unresectable Breast Carcinoma, Metastatic Breast Cancer
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).
Interventions
- Drug: BNT323 — Intravenous infusion
- Drug: BNT327 — Intravenous infusion
Primary outcomes
- Part 1 - Occurrence of dose limiting toxicities (DLTs) (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)
- 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 (From the time of initiation of the first dose of IMP to 90 days after the last IMP dose)
- Occurrence of dose interruption, reduction, and discontinuation due to TEAEs (From the time of initiation of the first dose of IMP to 90 days after the last IMP dose)
- Part 2 - Objective response rate (ORR) (From the time of initiation of the first dose of IMP to last tumor assessment scan, i.e., up to 36 months.)
Eligibility information
Study locations
- Beverly Hills Cancer Center, Beverly Hills, California 90211 United States
- Hoag Memorial Hospital Presbyterian, Newport Beach, California 92663 United States
- Hematology - Oncology Associates of the Treasure Coast, Port Saint Lucie, Florida 34952 United States
- University Cancer & Blood Center, LLC, Athens, Georgia 30607 United States
- Winship Cancer Institute of Emory University, Atlanta, Georgia 30322 United States
- University of Illinois Hospital & Health Sciences System, Chicago, Illinois 60612 United States
- Karmanos Cancer Institute, Detroit, Michigan 48201 United States
- Brigitte Harris Cancer Pavilion BHCP, Detroit, Michigan 48202 United States
- START Midwest, LLC, Grand Rapids, Michigan 49546 United States
- Saint Luke's Hospital of Kansas City, Kansas City, Missouri 64111 United States
Showing 10 of 79 reported sites. See the official listing for all locations.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-30.