Phase I Trial Evaluating Safety and Dosing of HRS-7525 Tablets in Men with Advanced Prostate Cancer

What this Trial Is About

Researchers are evaluating the safety and tolerability of HRS-7525 tablets in men with advanced prostate cancer. The study aims to identify dose limiting toxicity DLT, the maximum tolerated dose MTD, and the recommended Phase II dose RP2D of this drug. This Phase I trial focuses on patients with metastatic adenocarcinoma of the prostate, excluding neuroendocrine or small cell carcinoma types. Participants will receive HRS-7525 tablets during a single-group treatment period. The study includes a single-dose run-in period lasting 2 days, followed by 21 days after the first dose to assess dose limiting toxicity. The overall safety follow-up for each participant extends to about 13 months from informed consent to evaluate the maximum tolerated dose and recommended Phase II dose. During the study, participants will be monitored through clinical assessments to track safety, tolerability, and dosing effects. Researchers will evaluate adverse events, laboratory tests, and imaging to confirm metastatic lesions. Men with female partners of childbearing potential must use contraception during and for three months after treatment. The total participation duration includes the treatment period plus safety follow-up lasting approximately 13 months.

A Clinical Study of HRS-7525 Tablets in Patients With Advanced Prostate Cancer