Overview

This is a Phase 1b, multi-center, open-label study to evaluate the safety, tolerability, dosimetry, and pharmacokinetics (PK) of \[64Cu\]Cu-AKY-2519 and/or \[225Ac\]Ac-AKY-2519, as well as the preliminary anti-tumor activity of \[225Ac\]Ac-AKY-2519 in participants with metastatic castration-resistant prostate cancer (mCRPC) with and without prior exposure to 177Lu-PSMA-617 (PLUVICTO™).

Eligibility

Inclusion Criteria:

• Age ≥ 18 years
• Histologic or cytologic confirmation of prostatic adenocarcinoma
• ECOG Performance Status of 0 or 1
• Adequate end-organ function
• Ability to give informed consent and comply with study requirements
• Patients with CNS metastases are eligible if they have received therapy and are neurologically stable, asymptomatic and not receiving corticosteroids
• Castrate levels of serum testosterone (\< 50 ng/dL)
• Documented disease progression on most recent prior line of therapy, either by PSA or imaging-based progression
• Cohort B: Received 2 or more prior doses of 177Lu-PSMA-617 (PLUVICTO)

Exclusion Criteria:

• Prior treatment with more than 2 Androgen receptor pathway inhibitors (ARPIs) and/or more than 1 taxane-based therapy in the mCRPC setting
• Prior treatment with a targeted radiotherapy
  • Exception: Cohort B is required to have had at least 2 prior doses of 177Lu-PSMA-617 (PLUVICTO)
• Prior treatment with a B7-H3 targeted therapy
• Received an investigational agent within the previous 28 days
• Impaired cardiac function or clinically significant cardiac disease
• Concurrent serious medical condition that would impair study participation or impact the assessment of treatment related toxicity