A Phase II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics, and Efficacy of HS-20093 or SHR2554 Tablets in Combination With Novel Hormonal Agents in Participants With Metastatic Prostate Cancer
This is a phase II, multicentre clinical study investigating HS-20093 or SHR2554 in combination with a Novel Hormonal Agent (NHA) for advanced prostate cancer. The trial comprises two cohorts.
• Voluntarily participate in this clinical study, understand the research procedures, and are able to provide written informed consent.
• Aged 18 to 80 years (inclusive), male.
• ECOG performance status of 0 or 1.
• Expected survival time ≥12 weeks.
• Histologically or cytologically confirmed prostate adenocarcinoma, with no features of neuroendocrine carcinoma or small cell carcinoma.
• Able to provide sufficient tumor tissue samples for retrospective genetic testing.
• Ongoing Androgen Deprivation Therapy (ADT) throughout the study period, i.e., continuous treatment with a GnRH agonist or antagonist (chemical castration) or prior bilateral orchiectomy (surgical castration).
• PSA level ≥1 ng/ml at screening.
• Adequate organ function levels at baseline assessment.
⁃ Male participants with female partners of childbearing potential must agree to refrain from sperm donation and use effective contraception from the time of signing the informed consent form until 4.5 months after the last dose of HS-20093 or 3 months after the last dose of other study treatments, whichever is later.