Study of XNW5004 Tablets in Advanced Prostate Cancer

This study consists of two phases. The first phase (Phase Ib) is a safety lead-in study of XNW5004 in combination with anti-tumor therapy; the second phase (Phase II) is a dose expansion study of XNW5004 in combination with anti-tumor therapy. Phase Ib is a non-randomized, open-label study. Given the differences in mechanism of action, pharmacokinetic profiles, and toxicity profiles when XNW5004 is combined with different anti-tumor agents, the safety lead-in will be conducted independently for each combination cohort. Upon completion of the Cycle 1 safety evaluation for the corresponding cohort in Phase Ib, the Phase II study will be initiated. Phase II is a randomized, open-label, dose expansion study. A preliminary design of 5 cohorts will further evaluate the efficacy, safety, pharmacokinetics (PK), and pharmacodynamics (PD) of XNW5004 in combination with anti-tumor therapy in participants with advanced prostate cancer. The study process includes a screening period, a treatment period, and a follow-up period. Eligible participants after screening will enter the treatment period and receive therapy according to the combination regimen of their assigned cohort, until disease progression, death, withdrawal of informed consent, intolerable toxicity, or any other condition that the investigator deems necessary for study discontinuation. Participants will undergo PK and PD blood sampling at designated time points, and relevant anti-tumor efficacy assessments will be performed.