RecruitingCastration Resistant Metastatic Prostate CancerProstate CancermCRPC (Metastatic Castration-resistant Prostate Cancer)
A Study of [225Ac]Ac-AKY-2519 in Patients With Metastatic Castration-Resistant Prostate Cancer
Eligible age
18+ yrs
Accepts
Men
Locations
4 states
Healthy volunteers
No
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About this study
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™).
Sponsor: Aktis Oncology, Inc.
You may qualify if…
- ✓ 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
You may not qualify if…
- ✕ 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
Where it's recruiting
Source: ClinicalTrials.gov · NCT07581184 · last updated 2026-07-14