Table of Contents
- Trial overview
- Who the trial is for
- What is being studied
- Trial phases and design
- Outcomes being measured
- Trial status and size
Trial overview
This clinical trial is studying AMO959 in adults with PSMA-positive prostate cancer that has spread to other parts of the body.[1] The trial title and summary show that the study is focused on metastatic castration-resistant prostate cancer, also called mCRPC.[1]
The trial is looking at AMO959 given with AAA617 and, in some parts of the study, with an androgen receptor pathway inhibitor (ARPI).[1] The study is interventional, which means participants receive the study treatment rather than only being observed.[1]
Who the trial is for
The trial is designed for adults with PSMA-positive mCRPC who have already had at least one ARPI.[1] This means the cancer has kept growing despite strong hormone-based treatment.[1]
PSMA-positive means the cancer cells show prostate-specific membrane antigen, a marker used to identify the right study population.[1] The trial data do not describe other broad eligibility rules, so the main known group is this specific prostate cancer population.[1]
What is being studied
The main purpose is to learn about the safety and tolerability of AMO959 when it is combined with AAA617 and an ARPI.[1] Safety means how often unwanted medical problems happen, and tolerability means how well people can stay on treatment.[1]
The Phase Ib part is described as an escalation study, which means doses are studied step by step to help find a Recommended Dose for Expansion (RDE).[1] The Phase II part is meant to look at preliminary efficacy, which means early signs of whether the treatment may help.[1]
The trial also includes several prostate cancer treatments in the intervention list, including enzalutamide, abiraterone, prednison, degarelix, relugolix, Pluvicto, piflufolastat (18F), and gozetotide.[1] The source does not explain how each one is used in every participant, so the key point is that AMO959 is being studied in a treatment program for advanced prostate cancer.[1]
Trial phases and design
The study is listed as Phase 1 and has two main parts: Phase Ib and Phase II.[1] Phase Ib focuses on dose escalation, which means testing treatment levels carefully before moving forward.[1]
Phase II then looks at early effectiveness after the dose has been better defined.[1] This design helps researchers first check safety and dose, then look for signs that the treatment may work.[1]
Outcomes being measured
The main outcome is the incidence of dose-limiting toxicities (DLTs) during the first cycle of combination treatment.[1] DLTs are side effects serious enough to limit further dose increases or change the treatment plan.[1]
The study also measures adverse events, serious adverse events, laboratory value changes, vital signs, and deaths.[1] These measures help the research team understand how the treatment affects the body over time.[1]
Another set of outcomes looks at tolerability, including dose interruptions, dose reductions, discontinuation, dose intensity, and duration of exposure.[1] In simple terms, this shows whether people can keep taking the treatment and how much treatment they actually receive.[1]
The study also measures PSA50, which means a drop of at least 50% in prostate-specific antigen, confirmed by a second test taken at least 4 weeks later.[1] PSA is a blood marker often used in prostate cancer to track disease activity.[1]
Trial status and size
The trial is listed as Authorised.[1] The planned enrollment is 123 participants.[1]
Because only one trial record is provided, the article focuses on this single authorised study of AMO959 in advanced prostate cancer.[1] The source data do not provide final results, so the current information is about the study plan rather than the outcome.[1]
