Phase 3 BNT324 (DB-1311) B7-H3–targeted topoisomerase I–payload ADC vs docetaxel in mCRPC.

This randomized, open-label Phase 3 BioNTech SE study compares BNT324 (also known as DB-1311) with docetaxel plus prednisone/prednisolone in men with progressive metastatic castration-resistant prostate cancer who previously received an androgen receptor pathway inhibitor (ARPI) but have not received taxane chemotherapy for mCRPC. BNT324/DB-1311 is an antibody-drug conjugate from BioNTech and DualityBio that targets B7-H3 (CD276) on tumor cells and delivers a topoisomerase I inhibitor payload to drive DNA damage and cell death. The primary efficacy readouts are radiographic progression-free survival and overall survival, positioning this as a direct “new ADC vs first chemo” question in the post-ARPI, taxane-naïve window. Today, men in this setting commonly continue androgen deprivation therapy and then move to docetaxel chemotherapy; later options may include cabazitaxel, PARP inhibitors for HRR-mutated disease, radioligand therapy (when eligible), and sequential ARPIs with diminishing returns—so a positive readout could move a targeted ADC earlier than conventional chemo for a broad mCRPC population.