Clinical Trial

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 Phase 1/2

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 breast cancer (TNBC).

Protocol Amendment History 5 changes

notable Trial sites expanded: 56 -> 68 locations 2026-07-22

notable Trial sites expanded: 41 -> 56 locations 2026-06-24

notable Primary completion pushed: 2028-05 -> 2029-08 2026-06-24

minor Completion pushed: 2029-05 -> 2029-08 2026-06-24

notable Trial sites expanded: 34 -> 39 locations 2026-04-18

Trial Details

NCT Number	NCT06827236
Lead Sponsor	BioNTech SE Collaborators: DualityBio Inc., BioNTech (Shanghai) Pharmaceuticals Co., Ltd.
Conditions	Locally Advanced Breast Cancer, Unresectable Breast Carcinoma, Metastatic Breast Cancer
Enrollment	380 participants
Start Date	2025-04-23
Primary Completion	2029-08 (estimated)
Study Completion	2029-08 (estimated)
Updated on ClinicalTrials.gov	2026-07-21