Cancer Clinical Trials
A Study of [225Ac]Ac-AKY-2519 in Patients With Metastatic Castration-Resistant Prostate Cancer (BActinium-1)
Learn moreWhat is the purpose of this study?
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
- 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)
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Prior treatment with more than 2 Androgen receptor pathway inhibitors (ARPIs) and/or more than 1 taxane-based therapy in the mCRPC setting
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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)
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Prior treatment with a B7-H3 targeted therapy
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Received an investigational agent within the previous 28 days
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Impaired cardiac function or clinically significant cardiac disease
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Concurrent serious medical condition that would impair study participation or impact the assessment of treatment related toxicity
Where can I participate?
More about this Clinical TrialWhat is the full name of this Clinical Trial?
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
- Disease Type/ConditionCastration Resistant Metastatic Prostate Cancer, Prostate Cancer, B7H3, mCRPC, mCRPC (Metastatic Castration-resistant Prostate Cancer)
- Principal InvestigatorGary Ulaner, MD
- Co-InvestigatorsRyan Reddy, David Benjamin
- Age GroupAdult, Older Adult
- PhaseI
- ClinicalTrials.gov IDNCT07581184
- Key Eligibilityclinicaltrials.gov
- How do I learn more about this study?Beth Thomsen
MIT@hoag.org
Hoag Family Cancer Institute
Hoag Family Cancer Institute delivers advanced, compassionate cancer care across Orange County, with multidisciplinary specialists, precision therapies, support services, and access to 125+ cancer clinical trials. Patients benefit from research-driven care across a wide range of cancers, including breast, lung, gynecologic, prostate, gastrointestinal, and blood cancers.
