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GSK5458514

Phase 1

Neoplasms, Prostate | Small molecule | Oncology |GSK plc|Last Updated: Apr 24, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment85
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06990880A Study of GSK5458514 Administered Alone or In Combination With Other Anti-Cancer Agents in Participants With Prostate CancerPHASE1 RECRUITING 85 — — Jun 12, 2025Aug 9, 2028Apr 24, 202615 United States, Canada +3
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Study Endpoints
Primary Endpoints
Number of participants with dose limiting toxicities (DLTs) during DLT observation period
Up to 28 days
Number of participants with adverse events (AEs), serious adverse events (SAEs), by Severity
Up to approximately 29 months
Number of participants with AEs leading to dose modifications
Up to approximately 29 months
Secondary Endpoints
Area under concentration from 0 to t (AUC 0-t) of GSK5458514
Up to approximately 32 months
Maximum concentration (Cmax) of GSK5458514
Up to approximately 32 months
Time to reach maximum concentration (Tmax) of GSK5458514
Up to approximately 32 months
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Part 1: Dose escalation of GSK5458514 monotherapyEXPERIMENTAL -
Part 2: Dose expansion of GSK5458514 monotherapyEXPERIMENTAL -
Interventions
NameTypeDescription
GSK5458514DRUGGSK5458514 will be administered.
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Eligibility Criteria
Age Range18 Years — N/A
SexMALE
Healthy VolunteersNo
Study Sites15

Inclusion Criteria: * Provide signed informed consent. Participants must be capable of providing informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol. * Male participants ≥18 years of age (or the legal age of consent in the jurisd...

Countries:United StatesCanadaFranceJapanSpain
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06990880primaryCompletionDate: changed
LOWMay 24, 2026NCT06990880studyFirstPostDate: changed