A Clinical Study of QLC5508 and/or QLH12016 in Combination With Other Anti-tumor Therapies in Subjects With Advanced Prostate Cancer

Exclusion Criteria13

• 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.