A Study of [225Ac]Ac-AKY-2519 in Patients With Metastatic Castration-Resistant Prostate Cancer
Recruiting now · Phase 1
Conditions studied: Castration Resistant Metastatic Prostate Cancer, Prostate Cancer, mCRPC (Metastatic Castration-resistant Prostate Cancer), mCRPC, B7H3
In brief
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™).
Key facts
- Study ID
- NCT07581184
- Run by
- Aktis Oncology, Inc.
- People needed
- 138
- Starts
- 2026-07-01
- Expected to finish
- 2032-06-01
- Last updated by the study team
- 2026-07-14
Who can join
Age: 18 and older. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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
Where it is running
- Hoag Memorial Hospital Presbyterian — Irvine, California, United States (enrolling)
- Biogenix Molecular, LLC — Miami, Florida, United States (enrolling)
- BAMF Health — Grand Rapids, Michigan, United States (enrolling)
- XCancer — Omaha, Nebraska, United States (enrolling)
Full record on ClinicalTrials.gov
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