Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 16, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260916-000001
Summary
Brief summary (as posted)
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™).
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| B7H3 | — | UNRESOLVED | — |
| Castration Resistant Metastatic Prostate Cancer | Prostate Neoplasm | PROBABILISTIC | 0.70 |
| mCRPC | — | UNRESOLVED | — |
| mCRPC (Metastatic Castration-resistant Prostate Cancer) | Castration-Resistant Prostate Carcinoma | CURATED_BROADER | 0.78 |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| [225Ac]Ac-AKY-2519 (therapeutic) | Drug | — | UNRESOLVED |
| [64Cu]Cu-AKY-2519 (imaging) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- [225Ac]Ac-AKY-2519
- interventionNames
- Drug: [225Ac]Ac-AKY-2519 (therapeutic)
- Drug: [64Cu]Cu-AKY-2519 (imaging)
Primary outcomes (2)
- measure
- Occurrence of adverse events by severity and occurrence of serious adverse events (SAEs) in participants who received [225Ac]Ac-AKY-2519
- timeFrame
- Up to 30 days following last administration of [225Ac]Ac-AKY-2519
- description
- An AE is defined as any untoward medical occurrence in a participant administered study drug, which does not necessarily have to have a causal relationship with the study drug. The number of patients experiencing an AE and the number of patients experiencing an SAE will be reported. Up to 30 days following last administration of \[225Ac\]Ac-AKY-2519
- measure
- Occurrence of dose-limiting toxicity (DLT) in mCRPC participants with and without prior 177Lu-PSMA-617 exposure
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available