NCT07581184RecruitingPhase 1
A Study of [225Ac]Ac-AKY-2519 in Patients With Metastatic Castration-Resistant Prostate Cancer
BActinium-1: A Phase 1b, Multicenter, Open-label Study to Evaluate the Safety and Efficacy of Intravenous Administration of B7-H3 Radiopharmaceutical ([225Ac]Ac-AKY-2519) in Metastatic Castration-Resistant Prostate Cancer
Source: ClinicalTrials.gov · Last updated 2 Nov 2026
Brief summary (registry, in English)
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™).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 138 (estimated)
- First submitted
- 6 May 2026
- Start date
- 17 Jun 2026
- Primary completion date
- Dec 2027
- Lead sponsor
- Aktis Oncology, Inc.
- Diseases
- Prostate cancer
- NCT number
- NCT07581184
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 138
- From 17 Jun 2026 to the primary completion date, Dec 2027
- 8 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- Concurrent serious medical condition that would impair study participation or impact the assessment of treatment related toxicity
Other illness
- Impaired cardiac function or clinically significant cardiac disease
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (8)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Dana-Farber Cancer Institute Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| BAMF Health Coordinator of this site? Confirm its status | Grand Rapids | United States | Recruiting |
| Hoag Memorial Hospital Presbyterian Coordinator of this site? Confirm its status | Irvine | United States | Recruiting |
| University of Kansas Medical Center Coordinator of this site? Confirm its status | Kansas City | United States | Recruiting |
| East Jefferson General Hospital - LCMC Health Coordinator of this site? Confirm its status | Metairie | United States | Recruiting |
| Biogenix Molecular, LLC Coordinator of this site? Confirm its status | Miami | United States | Recruiting |
| XCancer Coordinator of this site? Confirm its status | Omaha | United States | Recruiting |
| UPMC Coordinator of this site? Confirm its status | Pittsburgh | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.