This study is an open-label, multicenter Phase Ib/II clinical trial designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of QLC5508 in combination with NHA (abiraterone or enzalutamide), QLC5508 in combination with QLH12016, QLC5508 in combination with QLH12016 and NHA (abiraterone or enzalutamide), and QLH12016 in combination with NHA (abiraterone or enzalutamide) in subjects with advanced prostate cancer.
The study consists of two stages:
Phase Ib: is the combination dose-escalation stage, during which the recommended Phase II dose (RP2D) will be determined.
Phase II is the efficacy exploration stage, in which, based on the RP2D established in Phase Ib, the therapeutic efficacy will be further evaluated in the target indication.
The subject voluntarily agrees to participate and has signed the informed consent form.
Male, aged ≥18 years.
Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
Life expectancy of at least 3 months.
Prior treatment with the following agents: AR PROTAC, abiraterone, enzalutamide, or B7H3-targeted therapies.
Presence of central nervous system (CNS) metastases, leptomeningeal metastases, or spinal cord compression requiring hormonal therapy.
Receipt of extensive radiotherapy within 4 weeks prior to the first administration of the investigational medicinal product.
Treatment with other investigational drugs or major surgery within 4 weeks prior to the first administration of the investigational medicinal product.