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

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 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…

Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov

Conditions studied

• Locally Advanced Breast Cancer
• Unresectable Breast Carcinoma
• Metastatic Breast Cancer

Eligibility basics and study details

Study type

Interventional

Phase

Phase 1/2

Ages

18 years and older

Sex

All

Healthy volunteers

Not accepted

Sponsor

BioNTech SE

Last updated on ClinicalTrials.gov

October 15, 2026

These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.

US recruiting sites