New hope for advanced prostate cancer: experimental drug cocktails enter human testing

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. * Histologically or cytologically confirmed adenocarcinoma of the prostate. * Radiologically confirmed metastatic prostate cancer. * For subjects with mCRPC, serum testosterone must be at castrate levels, and they must have demonstrated either PSA progression or radiographic progression. * Must have undergone surgical castration or be willing to receive medical castration. * For Phase Ib, subjects must have experienced failure, intolerance, or refusal of standard therapy. * Adequate function of major organs as defined by the protocol. * Agreement to use effective contraception during the study (except for subjects who have undergone bilateral orchiectomy). * Sufficient blood samples must be provided during the screening period for genetic mutation testing. Exclusion Criteria: * 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. * Presence of factors that may affect drug administration, intake, or absorption. * History of epilepsy, or a condition that could provoke seizures within 12 months prior to the first administration of the investigational medicinal product. * Known history of substance abuse, alcoholism, or drug addiction; or prior history of significant neurological or psychiatric disorders, including dementia or hepatic encephalopathy. * Presence of severe cardiovascular or cerebrovascular disease. * Active, uncontrolled infection. * Clinically uncontrolled third-space fluid accumulation prior to the first administration of the investigational medicinal product. * History of other malignancies within 5 years prior to the first administration of the investigational medicinal product. * Presence of moderate to severe pulmonary disease that significantly impairs lung function. * For subjects receiving QLC5508, history of non-infectious interstitial lung disease (ILD) or pneumonitis.