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New treatment option for Castration Resistant Metastatic Prostate Cancer
Official title A Study of [225Ac]Ac-AKY-2519 in Patients With Metastatic Castration-Resistant Prostate Cancer
ClinicalTrials.gov ID: NCT07581184
What this study is testing
What is [225Ac]Ac-AKY-2519 (therapeutic)?
[225Ac]Ac-AKY-2519 (therapeutic) is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for castration resistant metastatic prostate cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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™).
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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)
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Irvine, California, United States
- Miami, Florida, United States
- Grand Rapids, Michigan, United States
- Omaha, Nebraska, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Irvine, California, United States; Miami, Florida, United States; Grand Rapids, Michigan, United States; Omaha, Nebraska, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.