In short
GSK5471713B is an investigational oral substance being studied in a first-time-in-human clinical trial for adults with metastatic castration-resistant prostate cancer (mCRPC). The trial, NCT07332455, is a Phase 1/2 study that plans to enroll 54 participants and is currently authorised but not yet recruiting. Its main goal is to evaluate the safety and tolerability of GSK5471713B and to select two or more doses for further testing.
Key points
- GSK5471713B is an investigational substance with no marketing authorisation in the registry records.
- The only registered trial is a Phase 1/2 study in metastatic castration-resistant prostate cancer (mCRPC).
- The trial plans to enroll 54 participants and is currently authorised but not yet recruiting.
- The primary outcomes measure dose-limiting toxicities and adverse events at each dose level.
- GSK5471713B is given orally in the trial.
- The study aims to select two or more doses to move forward into Part 2.
What is GSK5471713B?
GSK5471713B is an investigational substance that is not yet authorised as a medicine in any country according to the registry records. It is being developed and studied by GSK. The substance appears in the EU Clinical Trials Information System (CTIS) records as the test product in a first-time-in-human study, meaning this is the earliest stage of testing in people. The full name used in the trial registry is GSK5471713B, and the short label GSK5471713B is used throughout this page.
In the trial data, GSK5471713B is classified as a chemical substance, meaning it is a chemically synthesised small molecule rather than a protein-based or biological product. The trial record does not provide an Anatomical Therapeutic Chemical (ATC) code or a trade name for GSK5471713B, which is consistent with its status as an early-stage investigational substance.
How does GSK5471713B work?
The registry records for this trial do not describe the mechanism of action of GSK5471713B. No molecular target, pathway, or pharmacodynamic explanation is provided in the available data. Because the substance is in a first-time-in-human Phase 1/2 study, detailed information about how it works in the body is typically limited at this stage and has not been included in the public registry record.
The trial is being conducted in participants with metastatic castration-resistant prostate cancer (mCRPC), a form of advanced prostate cancer that continues to grow despite treatment that lowers testosterone to very low levels. The study focuses on evaluating safety, tolerability, and dose selection rather than confirming a specific mechanism of action.
Which conditions is it studied for?
- Metastatic castration-resistant prostate cancer (mCRPC) — an advanced form of prostate cancer that has spread to other parts of the body and no longer responds to treatments that reduce testosterone levels. This is the only condition listed in the registered trial.
How is GSK5471713B given?
In the registered trial, GSK5471713B is administered by oral use, meaning it is taken by mouth. The trial interventions list three separate oral use arms of GSK5471713B, which suggests that different dose levels are being evaluated in the study. The registry record does not specify the pharmaceutical form, such as tablet, capsule, or solution, and no specific dose amounts are provided.
The product records from the CTIS indicate that the pharmaceutical form and route of administration are associated with the oral use of the substance in the trial setting. No information is available about whether other formulations or routes of administration are being developed.
What do the clinical trials show?
One clinical trial is registered for GSK5471713B: a Phase 1/2 study with the identifier NCT07332455. The trial is titled "First-Time-in-Human Study of GSK5471713 in Adults With mCRPC" and is currently authorised, meaning it has received regulatory approval to proceed but is not yet recruiting participants. The study plans to enroll 54 participants.
The trial is interventional, meaning participants receive the study drug and are followed over time. It is designed in two parts. Part 1 focuses on evaluating the safety and tolerability of GSK5471713B at different dose levels. Part 2 will use the doses selected from Part 1 to further evaluate the substance. The primary outcomes measured are the number of participants with dose-limiting toxicities (DLTs) at each dose level, the number of participants with adverse events (AEs), serious adverse events (SAEs), and AEs leading to dose modifications, and the severity of these events.
The trial does not list secondary outcome measures in the registry record. The study is focused on safety and dose selection rather than measuring how well the substance works against the cancer. Participants are adults with metastatic castration-resistant prostate cancer. The trial record does not provide specific inclusion or exclusion criteria beyond the condition itself.
What side effects are known?
The registry record for this trial does not report any side effects from completed studies because the trial is authorised but not yet recruiting. The primary purpose of the study is to identify side effects, including dose-limiting toxicities and adverse events, so safety information will become available only after the trial has been conducted and results are reported. No supplementary sources with side effect data were provided for this substance.