A Study of [225Ac]Ac-AKY-2519 in Patients With Metastatic Castration-Resistant Prostate Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: [225Ac]Ac-AKY-2519 (therapeutic), [64Cu]Cu-AKY-2519 (imaging).
- Who it may be relevant to
- Registry conditions: Castration Resistant Metastatic Prostate Cancer, Prostate Cancer, mCRPC (Metastatic Castration-resistant Prostate Cancer), mCRPC. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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™).
Detailed description
This Phase 1b study consists of a dose escalation portion and a backfill portion. The dose escalation portion will investigate ascending doses of \[225Ac\]Ac-AKY-2519 across two cohorts enrolling in parallel:
* Cohort A: participants with metastatic castration-resistant prostate cancer (mCRPC) with NO prior exposure to 177Lu-PSMA-617 (PLUVICTO™) and * Cohort B: participants with metastatic castration-resistant prostate cancer (mCRPC) with prior exposure to 177Lu-PSMA-617 (PLUVICTO™)
The backfill portion may enrich in two select dose levels from each cohort (Cohort A: mCRPC 177Lu-PSMA-617 (PLUVICTO™)-naïve; Cohort B: mCRPC 177Lu-PSMA-617 (PLUVICTO™)-experienced) to gather further information on the safety and efficacy and to determine the recommended phase 2 dose (RP2D) for each cohort.
Interventions
- Drug [225Ac]Ac-AKY-2519 (therapeutic)
\[225Ac\]Ac-AKY-2519 Injection - Drug [64Cu]Cu-AKY-2519 (imaging)
\[64Cu\]Cu-AKY-2519 Injection
Primary outcome measures
- Occurrence of adverse events by severity and occurrence of serious adverse events (SAEs) in participants who received [225Ac]Ac-AKY-2519 [Time frame: Up to 30 days following last administration of [225Ac]Ac-AKY-2519]
- Occurrence of dose-limiting toxicity (DLT) in mCRPC participants with and without prior 177Lu-PSMA-617 exposure [Time frame: From first administration of [225Ac]Ac-AKY-2519 to the end of Cycle 1 (each cycle is 28 days)]
Secondary outcome measures (6)
- Occurrence of adverse events by severity and occurrence of serious adverse events (SAEs) in participants who received [64Cu]Cu-AKY-2519 [Time frame: Up to 30 days following last administration of [64Cu]Cu-AKY-2519]
- Objective Response Rate (ORR) [Time frame: Up to 30 days following last administration of [225Ac]Ac-AKY-2519]
- Duration of Response (DoR) [Time frame: Up to 5 years after first administration]
- Progression-Free Survival (PFS) [Time frame: Up to 5 years after first administration]
- Prostate Specific Antigen (PSA) >= 50% Response Rate (PSA50) [Time frame: Up to 30 days following last administration of [225Ac]Ac-AKY-2519]
- Prostate Specific Antigen (PSA) >= 90% Response Rate (PSA90) [Time frame: Up to 30 days following last administration of [225Ac]Ac-AKY-2519]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 4 centers
- Hoag Memorial Hospital Presbyterian — Irvine
- Biogenix Molecular, LLC — Miami
- BAMF Health — Grand Rapids
- XCancer — Omaha
Identifiers
NCT: NCT07581184 · AKY-2519-01