AKY-2519 (B7‑H3 targeted radioligand) for 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
This trial tests whether AKY‑2519, a B7‑H3–targeted radioactive medicine used for imaging and treatment, is safe and can shrink tumors in men with metastatic castration‑resistant prostate cancer, including those who have had prior 177Lu‑PSMA‑617.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 138 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Aktis Oncology, Inc. Industry-sponsored |
| Locations | 2 sites (Miami, Florida and 1 other locations) |
| Trial ID | NCT07581184 on ClinicalTrials.gov |
What this trial studies
This Phase 1b, open‑label, multicenter study gives participants a diagnostic imaging dose ([64Cu]Cu‑AKY‑2519) and/or escalating therapeutic doses of an alpha emitter ([225Ac]Ac‑AKY‑2519) to measure safety, tolerability, dosimetry, and pharmacokinetics and to look for early signs of anti‑tumor activity. The trial enrolls two parallel cohorts: Cohort A without prior 177Lu‑PSMA‑617 exposure and Cohort B with prior 177Lu‑PSMA‑617 exposure, with a dose‑escalation stage followed by a backfill stage at selected dose levels. Investigators will collect imaging, laboratory, and clinical response data and use those results to recommend phase 2 dose(s) for each cohort. The primary focus is safety and dose finding; efficacy is evaluated as a secondary, preliminary outcome.
Who should consider this trial
Good fit: Ideal candidates are adults with histologically confirmed metastatic castration‑resistant prostate cancer, castrate testosterone levels, ECOG 0–1, adequate organ function, and, for Cohort B, at least two prior doses of 177Lu‑PSMA‑617.
Not a fit: Patients who previously received a B7‑H3 targeted therapy, have had more than the allowed number of prior ARPIs or taxane regimens, prior targeted radiotherapy (with limited exceptions), or poor performance status are unlikely to qualify or benefit from this trial.
Why it matters
Potential benefit: If successful, AKY‑2519 could offer a new targeted radioactive therapy option that delivers potent alpha radiation to B7‑H3–expressing prostate tumors, potentially shrinking disease including in some patients who progressed after PSMA‑targeted therapy.
How similar studies have performed: Radioligand therapies such as 177Lu‑PSMA‑617 and some early alpha‑emitter programs have shown activity in mCRPC, but B7‑H3–directed radioligand therapy is a newer approach with limited clinical data to date.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Miami, Florida and 1 other locations
- Biogenix Molecular, LLC — Miami, Florida, United States (Recruiting)
- BAMF Health — Grand Rapids, Michigan, United States (Recruiting)
Study contacts
- Study coordinator: Tiffany Wang, MD
- Email: AKY-2519-01inquiries@aktisoncology.com
- Phone: +1-857-216-8482
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.