Actively Recruiting
BActinium-1: Phase 1b Study of Intravenous [225Ac]Ac-AKY-2519 in Metastatic Castration-Resistant Prostate Cancer
Led by Aktis Oncology, Inc. · Updated on 2026-05-12
138
Participants Needed
2
Research Sites
234 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying metastatic castration-resistant prostate cancer (mCRPC) to evaluate the safety, tolerability, dosimetry, and pharmacokinetics of two investigational drugs, [64Cu]Cu-AKY-2519 and [225Ac]Ac-AKY-2519. This Phase 1b open-label study also explores the early anti-tumor activity of [225Ac]Ac-AKY-2519 in patients with mCRPC, including those who have and have not previously received 177Lu-PSMA-617 (PLUVICTO1).
CONDITIONS
Brief 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
- Confirmed diagnosis of prostatic adenocarcinoma by tissue testing
- ECOG Performance Status of 0 or 1 indicating good physical condition
- Adequate function of vital organs
- Ability to provide informed consent and follow study requirements
- Patients with stable, treated central nervous system metastases who are asymptomatic and not on corticosteroids
- Castrate levels of serum testosterone below 50 ng/dL
- Documented disease progression by PSA or imaging on the most recent prior therapy
- For Cohort B: Received at least 2 prior doses of 177Lu-PSMA-617 (PLUVICTO)
You will not qualify if you...
- Prior treatment with more than 2 androgen receptor pathway inhibitors or more than 1 taxane-based therapy in the mCRPC setting
- Prior treatment with targeted radiotherapy except for Cohort B who must have had at least 2 doses of 177Lu-PSMA-617
- Prior treatment with B7-H3 targeted therapy
- Received any investigational agent within 28 days before study
- Impaired heart function or significant cardiac disease
- Serious medical conditions that could affect participation or safety assessment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 28-day cycles until disease progression or discontinuation
Participants receive intravenous [225Ac]Ac-AKY-2519 as part of dose escalation or backfill portions to assess safety and efficacy.
Visits occur each cycle during treatment administration and assessments
Duration - Up to 30 days following last treatment administration
Participants are monitored for adverse events and treatment response after the last administration of [225Ac]Ac-AKY-2519.
Approximately 1 to 2 follow-up visits
Duration - Up to 5 years after first administration
Participants are followed for long-term outcomes including duration of response and progression-free survival.
Periodic visits for up to 5 years
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
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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