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
← catalyst calendarNCT06827236 · readout ≤ 1,108 d
Sponsored by BioNTech SE (industry) · BNTX — their whole pipeline →. With DualityBio Inc., BioNTech (Shanghai) Pharmaceuticals Co., Ltd..
Phase
Phase 1/2
Status
Recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
380estimated
Sites
68
Countries
Australia, Canada, China +8
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2025-04-23 | actual | When the study began enrolling |
| Primary completion | Aug 2029 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Aug 2029 | estimated | The whole study's end, after follow-up |
| First posted | 2025-02-14 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-07-21 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Locally Advanced Breast Cancer
- Unresectable Breast Carcinoma
- Metastatic Breast Cancer
Interventions
- Drug: BNT323 — also filed as trastuzumab pamirtecan, DB-1303
- Drug: BNT327 — also filed as Pumitamig, PM8002
Primary outcomes
what the primary-completion date above is the date OFPart 1 - Occurrence of dose limiting toxicities (DLTs)
measured 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
measured 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
measured 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)
measured From the time of initiation of the first dose of IMP to last tumor assessment scan, i.e., up to 36 months.
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