A Study to Assess the Safety, Pharmacokinetics, and Anti-Tumor Activity of Oral HP518 in Patients With Metastatic Castration-Resistant Prostate Cancer

Prior treatment

• Has received more than 1 line of chemotherapy for prostate cancer.
• Use of enzalutamide, and/or other second-generation AR inhibitors and/or abiraterone as follows:
  • Received any agent within 4 weeks prior to the start of study drug.
  • Discontinued agent without evidence of radiographic or PSA progression.
• Has had any anticancer treatments, including immunotherapy, chemotherapy, or radiotherapy (eg, 177Lu-PSMA-617, radium 223, PARP inhibitor) within 4 weeks prior to the first dose of HP518.
• Use of an investigational agent, without evidence of radiographic or PSA progression, within 4 weeks prior to the first dose of HP518 or a period required by local regulation, whichever is longer.

Other illness

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

• Has histologically confirmed adenocarcinoma of the prostate.
• Has metastatic disease at study entry documented by 2 or more bone lesions on bone scan or by soft tissue disease observed by CT/MRI.
• Has disease progression while receiving any ADT, androgen biosynthesis inhibitors, or second-generation AR inhibitors.
• 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.