A Phase III Trial of BNT324 Versus Docetaxel in Metastatic Castration-resistant Prostate Cancer

Key Inclusion Criteria: * Are male adults (defined as ≥18 years of age or of an acceptable age according to local regulations at the time of giving informed consent). * Must have documented progressive prostate cancer based on at least one of the following criteria: * Serum/plasma PSA progression, by local laboratory, defined as two consecutive increases in PSA over a previous reference value, each measured sequentially at least 1 week apart. The PSA value at screening is required to be ≥1.0 ng/mL. * Radiographic soft tissue progression as per PCWG3-modified RECIST v1.1. * Radiographic progression of bone disease: evaluable disease or new bone lesion(s) by bone scan per PCWG3 criteria. * Had previously received one or two prior androgen receptor pathway inhibitor treatments and experienced disease progression during or after a minimum of 8 weeks of therapy. * Must not have received systemic cytotoxic chemotherapy, including taxane-based chemotherapy, for mCRPC. * Must have had prior orchiectomy and/or have ongoing androgen-deprivation therapy and a castrate-level of serum/plasma testosterone (\<50 ng/dL or \<1.7 nmol/L). Participant being treated with luteinizing hormone-releasing hormone agonists or antagonists must continue such treatment throughout the study. * Must have an Eastern Cooperative Oncology Group performance score of 0 or 1. Key Exclusion Criteria: * Have received prior treatment with B7-H3 targeted therapy, including B7-H3 ADCs. * Have uncontrolled o…