Actively Recruiting
A Study of [225Ac]Ac-AKY-2519 in Patients With Metastatic Castration-Resistant Prostate Cancer
Led by Aktis Oncology, Inc. · Updated on 2026-05-12
138
Participants Needed
2
Research Sites
308 weeks
Total Duration
On this page
AI-Summary
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™).
CONDITIONS
Official Title
A Study of [225Ac]Ac-AKY-2519 in Patients With Metastatic Castration-Resistant Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- 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)
You will not qualify if you...
- 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 (except Cohort B must 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Biogenix Molecular, LLC
Miami, Florida, United States, 33165
Actively Recruiting
2
BAMF Health
Grand Rapids, Michigan, United States, 49503
Actively Recruiting
Research Team
T
Tiffany Wang, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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