A Study to Assess the Safety, Pharmacokinetics, and Anti-Tumor Activity of Oral HP518 in mCRPC Patients

Prior treatment

• Combination of research or commercially available drugs targeting AR
• Has had any other anticancer treatments, including immunotherapy, chemotherapy, or radiotherapy (eg, 177LuPSMA-617, radium 223, PARP inhibitor) within 4 weeks prior to the first dose of HP518.

Other illness

• Has gastrointestinal disorder affecting absorption (e.g., gastrectomy).
• Has significant cardiovascular disease.

• Male, age ≥18
• Patients with androgen receptor (AR) ligand binding domain (LBD) activation mutations (the dose expansion part of stage II)
• Has histologically confirmed adenocarcinoma of the prostate, but there are no known significant neuroendocrine differentiation or small cell characteristics.
• Has metastatic disease documented by 2 or more bone lesions by bone scan or soft tissue disease progression observed by CT/MRI at the beginning of study.
• the progression of the disease after receiving at least one new endocrine therapy and progressing with at least first-line chemotherapy.
• Must have recovered from toxicities related to any prior treatments
• Ongoing ADT with LHRH agonist/antagonist therapy or history of bilateral orchiectomy.
• ECOG performance status score of 0 to 1.