ARX517 in Subjects With Metastatic Castration-resistant Prostate Cancer

Key Inclusion Criteria:

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

Key Exclusion Criteria:

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