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GSK5471713

Phase 1

Neoplasms, Prostate | Small molecule | Oncology |GSK plc|Trials Updated: Sep 16, 2026

GSK5471713 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Jan 2026

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment54

FDA Designations

No designations recorded

GSK5471713 clinical trials

GSK5471713 · 1 trial · 1 indication

Phase 1 1
NCT07332455First-Time-in-Human Study of GSK5471713 in Adults With mCRPCNeoplasms, Prostate
RECRUITING54 Analytics
PHASE1RECRUITING
First-Time-in-Human Study of GSK5471713 in Adults With mCRPC
Neoplasms, ProstateUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of participants with dose limiting toxicities (DLTs)
28 days
Number of participants with adverse events (AEs), and serious adverse events (SAEs)
Approximately 45 months
Number of participants with adverse events (AEs), and serious adverse events (SAEs) by Severity
Approximately 45 months
Number of participants with AEs leading to dose modifications
Approximately 45 months

Secondary Endpoints

Maximum plasma concentration (Cmax) of GSK5471713
Approximately 45 months
Area under the plasma concentration-time curve from 0 to t (AUC[0-t]) of GSK5471713
Approximately 45 months
Time to maximum plasma concentration (Tmax) of GSK5471713
Approximately 45 months
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Participants receiving GSK5471713EXPERIMENTALParticipants will receive GSK5471713, according to their allocated dose level guided by the dose escalation study design.

Interventions

NameTypeDescription
GSK5471713DRUGGSK5471713 will be administered at different dose levels based on the dose escalation study design
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Eligibility Criteria

Age Range18 Years to N/A
SexMALE
Healthy VolunteersNo
Study Sites16

Inclusion Criteria: * Participants with mCRPC that have histologically or cytologically confirmed adenocarcinoma of the prostate. * Participants with mCRPC that has prostate cancer progression while on Androgen deprivation therapy (ADT). * Eastern Cooperative Oncology Group (ECOG) performance statu...

Countries:United StatesAustraliaCanadaFranceJapanNetherlandsSouth KoreaSpain
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Recent Changes (Last 90 Days)

LOWSep 16, 2026NCT07332455lastUpdatePostDate: changed
LOWSep 16, 2026NCT07332455lastUpdatePostDate: changed
LOWJul 24, 2026NCT07332455lastUpdatePostDate: changed
LOWJul 24, 2026NCT07332455lastUpdatePostDate: changed

Frequently asked questions about GSK5471713

What is GSK5471713?

GSK5471713 is an investigational small molecule developed by GSK plc for the treatment of prostate neoplasms. It is currently in Phase 1 clinical development and is being studied in adults with metastatic castration-resistant prostate cancer (mCRPC). It has not been approved by any regulatory agency.

What is GSK5471713 used for?

GSK5471713 is being evaluated for the treatment of prostate cancer, specifically metastatic castration-resistant prostate cancer (mCRPC). It is an investigational therapy in Phase 1 testing and is not approved for any indication. The ongoing study enrolls adult male patients aged 18 years and older.

Who is developing GSK5471713?

GSK5471713 is being developed by GSK plc, which trades under the ticker GSK. GSK is the sponsor of the Phase 1 first-time-in-human study evaluating the compound in patients with metastatic castration-resistant prostate cancer.

What phase is GSK5471713 in?

GSK5471713 is in Phase 1 clinical development. It is an investigational small molecule and has not received FDA approval. The single ongoing trial is a first-time-in-human study that is currently recruiting participants with metastatic castration-resistant prostate cancer.

What clinical trials is GSK5471713 in?

GSK5471713 is being studied in one active clinical trial, NCT07332455, titled First-Time-in-Human Study of GSK5471713 in Adults With mCRPC. The Phase 1 trial is recruiting 54 participants across the United States, Australia, Canada, France, Japan, Netherlands, South Korea, and Spain. It is an uncontrolled study.