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

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 or significant cardiovascular disease, as defined in the protocol.
• Have a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids or have current ILD/pneumonitis. NOTE: Other protocol defined Inclusion/Exclusion criteria apply.