ARX517 in Subjects With Metastatic Castration-resistant Prostate Cancer

Open to males ages 18 years and up

• Male subjects ≥ 18 years at the first time of providing written informed consent.
• Histologically confirmed prostate adenocarcinoma.
• Documented metastatic disease.
• Castration-resistant prostate cancer per the Prostate Cancer Working Group 3 (PCWG3).
• Ongoing therapy with (and willing to continue with) a gonadotropin-releasing hormone agonist or antagonist (unless prior orchiectomy) AND serum testosterone level < 50 ng/dL at Screening.
• Prior treatment with at least two FDA-approved therapies for metastatic prostate cancer with at least one being an androgen receptor signaling inhibitor
• Adequate blood counts

• Have central nervous system (CNS) metastasis, unless the CNS metastasis was treated with local therapy and has proven to be stable over the last 2 months prior to the enrollment date, and not currently requiring ongoing systemic steroid treatment
• History of any invasive malignancy (other than primary) within previous 2 years prior to the enrollment date that requires active therapy
• Marked baseline prolongation of QT/QT interval corrected for heart rate (QTc), e.g., a triplicate average QTc interval > 480 milliseconds (CTCAE Grade 1) using Fridericia's QT correction formula.
• Prior history of interstitial lung disease, pneumonitis, or other clinically significant lung disease within 12 months prior to enrollment date
• Clinically significant ocular findings by a qualified ophthalmologist or optometrist including active ocular infections or chronic corneal disorders