This study is designed to determine if experimental treatment with QLH12016 in combination with novel hormonal agent (NHA) is safe, tolerable, and has anti-cancer activity in patients with advanced prostate cancer.
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Inclusion Criteria: * Signed the informed consent form. * Male, aged ≥ 18 years. * Life expectancy ≥ 3 months. * Histologically or cytologically confirmed prostate adenocarcinoma. * Metastatic prostate cancer. * Organ function meet protocol requirements. * Recovered from all reversible AEs related to previous anticancer treatments. Exclusion Criteria: * Previous treatment with the following drugs: 1. AR PROTAC class drugs. 2. Other systemic anticancer therapy within 3 weeks or 5 half-lives prior to the first administration of the study treatment. 3. Taditional Chinese medicine with anti-tumor indications within 2 weeks prior to the first administration of the study treatment. 4. Drugs that may cause drug-drug interactions (DDI) with the study treatment. 5. Drugs known to prolong the QT interval or potentially cause torsades de pointes ventricular tachycardia * Presence of central nervous system metastases, leptomeningeal metastasis, or spinal cord compression. * Radiation therapy involving more than 25% of bone marrow within 4 weeks prior to the first administration of the investigational medicinal product; local radiation therapy within 2 weeks prior to the first administration of the investigational medicinal product. * Treatment with other investigational drugs or major surgery within 4 weeks. * Inability to swallow, chronic diarrhea, intestinal obstruction, or other factors affecting drug intake and absorption. * With severe cardiovascular or cerebrovascular diseases or related history. * Active, uncontrolled infections. * History of other significant malignancies within 5 years. * Moderate to severe pulmonary disease significantly affecting lung function. * According to the investigator's judgment, there are comorbidities that seriously endanger subject safety or affect the subject's ability to complete the study. * Allergy to any of the investigational medicinal products or their components.