NCT07581184 A Study of [225Ac]Ac-AKY-2519 in Patients With Metastatic Castration-Resistant Prostate Cancer
| NCT ID | NCT07581184 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Aktis Oncology, Inc. |
| Condition | Castration Resistant Metastatic Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 138 participants |
| Start Date | 2026-07 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 138 participants in total. It began in 2026-07 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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™).
Eligibility Criteria
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 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 * 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07581184 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Castration Resistant Metastatic Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07581184 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07581184 currently recruiting?
Yes, NCT07581184 is actively recruiting participants. Contact the research team at AKY-2519-01inquiries@aktisoncology.com for enrollment information.
Where is the NCT07581184 trial being conducted?
This trial is being conducted at Irvine, United States, Miami, United States, Grand Rapids, United States, Omaha, United States.
Who is sponsoring the NCT07581184 clinical trial?
NCT07581184 is sponsored by Aktis Oncology, Inc.. The trial plans to enroll 138 participants.
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