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™).
Age ≥ 18 years
Histologic or cytologic confirmation of prostatic adenocarcinoma
ECOG Performance Status of 0 or 1
Adequate end-organ function
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
Prior treatment with a B7-H3 targeted therapy
Received an investigational agent within the previous 28 days
Single group
[225Ac]Ac-AKY-2519 (therapeutic)
Drug\[225Ac\]Ac-AKY-2519 Injection
[64Cu]Cu-AKY-2519 (imaging)
Drug\[64Cu\]Cu-AKY-2519 Injection
Occurrence of adverse events by severity and occurrence of serious adverse events (SAEs) in participants who received [225Ac]Ac-AKY-2519
An AE is defined as any untoward medical occurrence in a participant administered study drug, which does not necessarily have to have a causal relationship with the study drug. The number of patients experiencing an AE and the number of patients experiencing an SAE will be reported. Up to 30 days following last administration of \[225Ac\]Ac-AKY-2519
Occurrence of dose-limiting toxicity (DLT) in mCRPC participants with and without prior 177Lu-PSMA-617 exposure
Dose-limiting toxicities (DLTs) is defined as any predefined AE occurring during the DLT observation period, except those that are clearly and incontrovertibly due to extraneous circumstances. The number of patients who experience a DLT will be reported separately for each cohort and by dose level within each cohort.
Occurrence of adverse events by severity and occurrence of serious adverse events (SAEs) in participants who received [64Cu]Cu-AKY-2519
An AE is defined as any untoward medical occurrence in a participant administered study drug, which does not necessarily have to have a causal relationship with the study drug. The number of patients experiencing an AE will be reported.
Objective Response Rate (ORR)
ORR is defined as the percentage of patients who achieved a best overall response of confirmed Complete Response (CR) or Partial Response (PR), as determined by the investigator based on PCWG3-modified RECIST v1.1.
Duration of Response (DoR)
Duration of Response (DoR) is defined as the time from the date of the first documentation of objective response (complete response \[CR\] or partial response \[PR\]) to the date of the first objective documentation of progressive disease (PD) or death due to any cause.
Progression-Free Survival (PFS)
PFS is defined as the time from treatment initiation to the first documented disease progression per RECIST 1.1 or death due to any cause, whichever occurs first.
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