Table of Contents
- Trial overview
- Who can join the study
- What is being measured
- Trial design and phase
- Key points for patients
Trial overview
The listed clinical trial is a first-time-in-human study of GSK5458514 in participants with metastatic castration-resistant prostate cancer (mCRPC).[1] The study is testing GSK5458514 given alone or together with other anti-cancer agents.[1] It is an interventional trial, which means participants receive a study treatment and researchers measure the results.[1]
Who can join the study
This study is for participants with prostate cancer that has spread and no longer responds to hormone treatment, which is what mCRPC means.[1] The trial title shows that the target population is people with this advanced form of prostate cancer.[1] The planned enrollment is 45 participants, so this is a small early study.[1]
What is being measured
The main safety measure is the number of participants with dose limiting toxicities (DLTs) during the DLT observation period.[1] DLTs are side effects that are serious enough to limit dose increases.[1] The study also counts adverse events (AEs), serious adverse events (SAEs), and side effects that lead to dose modifications.[1]
The brief summary says the study aims to determine the maximum tolerated dose (MTD) and maximum administered dose (MAD) of GSK5458514 and to evaluate safety and tolerability in participants with mCRPC.[1] MTD means the highest dose that can be given without unacceptable side effects, and MAD means the highest dose actually given in the study.[1]
Trial design and phase
The study is a Phase 1/2 trial, which is an early stage of clinical research.[1] Phase 1/2 studies usually focus first on safety and dose finding, then begin to look for early signs of benefit.[1] The trial status is Authorised.[1]
Key points for patients
- The study is testing GSK5458514 in a specific group: people with mCRPC.[1]
- Researchers are checking safety, side effects, and the best dose to use in future studies.[1]
- The treatment is being studied alone and in combination with other anti-cancer agents.[1]
- This is an early trial with 45 planned participants, so it is mainly about learning how the treatment behaves in people.[1]
