Clinical Trial

BNT324-03 A Phase III, randomized, open-label trial of BNT324 versus docetaxel with prednisone/prednisolone in metastatic castration-resistant prostate cancer

MOA: BNT324 is an ADC composed of a anti-human B7-H3 IgG1 mAb covalently linked to a topo I inhibitor (P1021) via a tetrapeptide based cleavable linker.

Key Eligibility Criteria:

• Subjects must have histological, pathological, and/or cytological confirmation of prostate cancer that is progressive
• Subjects must have previously received at least one 1-2 prior ARPI in either non-metastatic HSPC, mHSPC, non-metastatic CRPC, or mCRPC and had progressive disease during or after at least 8 weeks of treatment
• Subjects must have ≥1 metastatic lesion
• Subjects with a positive 68Ga-PSMA-11 PET/CT scan may have received prior 177Lu-PSMA or investigational PSMA-targeted radioligand therapy if treatment was completed more than 8 weeks before trial dosing
• Subjects must have had prior orchiectomy and/or have ongoing ADT and a castrate-level of serum/plasma testosterone (<50 ng/dL or <1.7 nmol/L)
• Subjects that previously received an ADC with a topoisomerase inhibitor, B7-H3 targeted therapy, or cytotoxic chemotherapy are excluded