RECRUITING Phase 1 ClinicalTrials.gov

A Study of [225Ac]Ac-AKY-2519 in Patients With Metastatic Castration-Resistant Prostate Cancer

Sponsor: Aktis Oncology, Inc. • ClinicalTrials.gov ID: NCT07581184

Registry updated: 2026-09-15

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Description

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™).

Interventions

[225Ac]Ac-AKY-2519 (therapeutic) (Drug)
\[225Ac\]Ac-AKY-2519 Injection
[64Cu]Cu-AKY-2519 (imaging) (Drug)
\[64Cu\]Cu-AKY-2519 Injection

Eligibility criteria

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 o 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

Conditions

Castration Resistant Metastatic Prostate Cancer Prostate Cancer mCRPC (Metastatic Castration-resistant Prostate Cancer) mCRPC B7H3

Locations

Hoag Memorial Hospital Presbyterian — Irvine, California, United States
Biogenix Molecular, LLC — Miami, Florida, United States
University of Kansas Medical Center — Kansas City, Kansas, United States
Dana-Farber Cancer Institute — Boston, Massachusetts, United States
BAMF Health — Grand Rapids, Michigan, United States
XCancer — Omaha, Nebraska, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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