A new drug, ifinatamab deruxtecan, has entered a phase 3 clinical trial for patients with metastatic castration-resistant prostate cancer (mCRPC) who have progressed after treatment with androgen receptor pathway inhibitors, such as abiraterone or enzalutamide. The trial, named IDeate-Prostate01, began dosing its first patient in June 2025 and compares the drug’s effectiveness and safety to docetaxel, a standard chemotherapy used in mCRPC treatment. Ifinatamab deruxtecan is an antibody drug conjugate that targets B7-H3, a protein commonly found on prostate cancer cells. It works by attaching to these cells and delivering a chemotherapy payload directly to them, aiming to destroy the cancer while minimizing damage to healthy tissue.

The global study, enrolling approximately 1,440 patients across Asia, Europe, North America, and Oceania, is designed to measure overall survival and the time patients live without disease progression. Secondary measures include response rates, time to subsequent treatments, and pain progression. Earlier phase 1 and 2 trials, presented at the 2022 and 2023 European Society of Medical Oncology Congresses, showed promising 25% tumor response rates in heavily pretreated mCRPC patients, prompting this larger trial.

Ifinatamab deruxtecan’s approach differs from existing treatments by targeting B7-H3, which is overexpressed in many prostate cancers, potentially offering an alternative for patients who no longer respond to hormone-based therapies. The trial’s results, expected by June 2028, could influence the treatment landscape for mCRPC.

Clinical trial.

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