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

Korábbi kezelés

• 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.
• Clinically uncontrolled third-space fluid accumulation prior to the first administration of the investigational medicinal product.
• For subjects receiving QLC5508, history of non-infectious interstitial lung disease (ILD) or pneumonitis.

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• Presence of severe cardiovascular or cerebrovascular disease.
• Active, uncontrolled infection.
• 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.

• 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.