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GSK5471713

Phase 1

Neoplasms, Prostate | Small molecule | Oncology |GSK plc|Last Updated: Jul 24, 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

Clinical trial landscape

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 Sites11

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 StatesAustraliaCanadaJapanSouth Korea
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Recent Changes (Last 90 Days)

LOWJul 24, 2026NCT07332455lastUpdatePostDate: changed
LOWJul 24, 2026NCT07332455lastUpdatePostDate: changed
LOWJul 6, 2026NCT07332455lastUpdatePostDate: changed
LOWJul 6, 2026NCT07332455lastUpdatePostDate: changed
LOWJun 18, 2026NCT07332455lastUpdatePostDate: changed
LOWJun 18, 2026NCT07332455lastUpdatePostDate: changed
LOWJun 18, 2026NCT07332455lastUpdatePostDate: changed

Frequently asked questions about GSK5471713

What is GSK5471713 used for?

GSK5471713 is an investigational small molecule being developed for the treatment of prostate neoplasms, specifically metastatic castration-resistant prostate cancer (mCRPC). It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

Who makes GSK5471713?

GSK5471713 is being developed by GSK plc, a global biopharmaceutical company listed on the stock exchange under the ticker GSK. The company is conducting a first-time-in-human study of this investigational drug in adults with mCRPC.

What phase is GSK5471713 in?

GSK5471713 is in Phase 1 clinical development. It is currently being evaluated in a first-time-in-human study that is recruiting participants. The drug is investigational and has not received regulatory approval for any indication.

What clinical trials is GSK5471713 in?

GSK5471713 is being studied in a Phase 1 clinical trial with the identifier NCT07332455. This is a first-time-in-human study in adults with metastatic castration-resistant prostate cancer (mCRPC), enrolling 54 participants across the United States, Australia, Canada, Japan, and South Korea.

Is GSK5471713 FDA approved?

GSK5471713 is not FDA approved. It is an investigational drug currently in Phase 1 clinical trials, meaning it is still in the early stages of clinical development and has not been evaluated for safety and efficacy in large-scale studies.