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
About This Trial
- This early-stage study is testing a new targeted radiation medicine to see if it is safe and can help shrink or slow prostate cancer that has spread and stopped responding to standard hormone treatments.
- It is open to adults whose cancer has continued to grow, including those who have already received the radiation treatment Pluvicto.
- Because this is a first-phase trial, the main goal is to find the safest dose and carefully track any side effects.
- Before considering this study, patients should know that they must be in generally good daily health and cannot have certain serious heart problems or have received too many prior chemotherapy and hormone therapies.
More Information
- 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™).
Who Can Enroll
- Age Range: 18 years and older
- Gender: Male
- Who This Trial is For: This early-stage study is testing a new targeted radiation medicine to see if it is safe and can help shrink or slow prostate cancer that has spread and stopped responding to standard hormone treatments.
Study Details
- Start Date: June 17, 2026
- Lead Sponsor: Aktis Oncology, Inc.
Full 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
Treatments
- Drug: [225Ac]Ac-AKY-2519 (therapeutic)
- Drug: [64Cu]Cu-AKY-2519 (imaging)