Table of contents
- Trial overview
- Who can participate
- What is being measured
- Trial phase and design
- Treatment approaches in the study
- Key patient terms
Trial overview
The available study of GSK5458514 is a first-time-in-human, Phase 1/2 interventional trial in participants with metastatic castration-resistant prostate cancer (mCRPC).[1] It is authorised and plans to enroll 45 participants.[1]
The main purpose of the study is to determine the maximum tolerated dose and the maximum administered dose, while also checking safety and tolerability.[1]
Who can participate
The study is designed for participants with mCRPC, which means prostate cancer that has spread and no longer responds to castration-based hormone control.[1] The source data do not list other detailed eligibility rules, so only this target population can be confirmed here.[1]
The title of the trial says that GSK5458514 is being given either alone or together with other anti-cancer agents, so the study population is being evaluated in more than one treatment setting.[1]
What is being measured
The primary outcomes focus on safety.[1] Researchers are counting dose-limiting toxicities during the DLT observation period.[1]
The study also measures the number of participants with adverse events and serious adverse events, including how severe they are.[1] Another outcome is the number of participants whose adverse events lead to dose modifications.[1]
These measures help researchers understand whether the treatment can be given safely and which dose range may be suitable for future study.[1]
Trial phase and design
This is a Phase 1/2 study, which means it combines early safety and dose-finding work with additional evaluation in the target cancer group.[1] The study is interventional, so participants receive a study treatment rather than only being observed.[1]
The trial is described as a first-time-in-human study, meaning this is the first clinical testing of GSK5458514 in people according to the source data.[1]
Treatment approaches in the study
GSK5458514 is being administered by intravenous use, which means it is given through a vein.[1] The study includes use of GSK5458514 alone and also in combination with other anti-cancer agents.[1]
This design allows researchers to look at the treatment in more than one setting, but the source data do not provide the names of the other anti-cancer agents.[1]
Key patient terms
Metastatic means the cancer has spread to other parts of the body.[1] Castration-resistant means the cancer is no longer controlled by standard hormone suppression.[1]
Tolerability means how well people can handle the treatment without side effects becoming too difficult.[1] Safety means whether the treatment causes harmful problems in participants.[1]
DLT observation period is the time when researchers watch closely for serious side effects that may limit the dose.[1] Enrollment means the number of people planned for the study.[1]
