A Study of [225Ac]Ac-AKY-2519 in Patients With Metastatic Castration-Resistant Prostate Cancer
Recruiting · NCT07581184 · Interventional (participants receive a specific treatment) · Lead sponsor: Aktis Oncology, Inc.
View the official record on ClinicalTrials.gov →Interventions studied
[225Ac]Ac-AKY-2519 (therapeutic)[64Cu]Cu-AKY-2519 (imaging)
What this trial is about
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™).
Who can take part
Age range
18 Years and older
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
4 locations listed across 4 US states.
- Hoag Memorial Hospital Presbyterian - Irvine, California, United States
- Biogenix Molecular, LLC - Miami, Florida, United States
- BAMF Health - Grand Rapids, Michigan, United States
- XCancer - Omaha, Nebraska, United States