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