Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT07581184 · ClinicalTrials.gov registry record · Phase 1
A Study of [225Ac]Ac-AKY-2519 in Patients With Metastatic Castration-Resistant Prostate Cancer
A Phase 1 study, sponsored by Aktis Oncology.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 138
- Enrollment target
NCT07581184: Recruiting Phase 1 study, sponsored by Aktis Oncology.
NCT07581184 is a Phase 1 study that is actively recruiting participants, run by Aktis Oncology. The registered enrollment target is 138 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (130% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07581184, a Phase 1 study, is actively recruiting participants, sponsored by Aktis Oncology.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 138 participants
- Enrollment target
Study Summary
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™).
Primary Outcome
An AE is defined as any untoward medical occurrence in a participant administered study drug, which does not necessarily have to have a causal relationship with the study drug. The number of patients experiencing an AE and the number of patients experiencing an SAE will be reported. Up to 30 days following last administration of \[225Ac\]Ac-AKY-2519
Interventions
- DRUG [225Ac]Ac-AKY-2519 (therapeutic)
- DRUG [64Cu]Cu-AKY-2519 (imaging)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 138 participants |
| Start Date | 2026-07 |
| Est. Completion | 2032-06 |
| Phase | Phase 1 |
What NCT07581184 shows while recruiting
NCT07581184 is an interventional study that assigns participants to a tested intervention. The registered 138 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (130% higher).
The record links to 0 conditions, and to 2 interventions - of which [225Ac]Ac-AKY-2519 (therapeutic) is the first listed.
NCT07581184 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07581184 about?
NCT07581184 is a clinical study titled "A Study of [225Ac]Ac-AKY-2519 in Patients With Metastatic Castration-Resistant Prostate Cancer". 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-resistan...
What is the current status of trial NCT07581184?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 138 participants. The study started on 2026-07. Estimated completion is 2032-06.
What interventions are being tested in trial NCT07581184?
The interventions under investigation include: [225Ac]Ac-AKY-2519 (therapeutic) (DRUG), [64Cu]Cu-AKY-2519 (imaging) (DRUG).
Who is sponsoring clinical trial NCT07581184?
This trial is sponsored by Aktis Oncology, which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07581184's enrollment target sits among peer trials
138 418th of 2000 higher than 1,581 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04402788 · 138 participants · Phase 2
Testing the Addition of Radiation Therapy to the Usual Immune Therapy Treatment (Atezolizumab) for Extensive Stage Small Cell Lung Cancer, The RAPTOR Trial
- NCT04883255 · 138 participants · Early Phase 1
Cannabis Use, Cognition, and the Endocannabinoid System in HIV
- NCT05620784 · 138 participants · Phase 3
Intra-operative Loop Diuretics to Improve Same-day Discharge Rates After HoLEP
- NCT05832086 · 138 participants · Phase 2
Intermittent Fasting Using a Fasting-Mimicking Diet to Improve Prostate Cancer Control and Metabolic Outcomes
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia