Clinical Trial

Safety and Preliminary Effectiveness of BNT327, an Investigational Therapy for Breast Cancer, When Given in Combination With Chemotherapy

Active, Not Recruiting Phase 2
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Summary
This study is a Phase II, multi-site, randomized, open-label clinical study to evaluate the safety, efficacy, and pharmacokinetics (PK) of BNT327 at two dose levels in combination with chemotherapeutic agents in the first- and second-line treatment of participants with locally advanced/metastatic triple-negative breast cancer (mTNBC).
Protocol Amendment History 18 amendments
This ClinicalTrials.gov record has been amended 18 times since 2024-06-03; most recent amendment 2026-06-29.
Status change: Recruiting → Active, Not Recruiting 2026-02-23
Status change: Not Yet Recruiting → Recruiting 2024-08-26
Trial Details
NCT Number NCT06449222
Lead Sponsor BioNTech SE
Collaborators: Bristol-Myers Squibb
Conditions Locally Advanced Breast Cancer, Triple Negative Breast Cancer, Metastatic Triple Negative Breast Cancers
Enrollment 83 participants
Start Date 2024-08-26
Primary Completion 2028-08 (estimated)
Study Completion 2029-06 (estimated)
Updated on ClinicalTrials.gov 2026-06-30