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GSK5460025

Phase 1

Neoplasms, Colorectal | Small molecule | Oncology |GSK plc|Last Updated: Jun 5, 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
CONTROLLEDBiomarker
Total Trials1
Total Enrollment47
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07213609A Study to Investigate the Safety and Preliminary Efficacy of GSK5460025 Alone or in Combination With Other Anti-cancer Agents in Participants With Solid TumorsPHASE1 RECRUITING 47Oct 20, 2025Oct 27, 2028Jun 5, 202613 United States, Canada +3
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Study Endpoints
Primary Endpoints
Part 1: Number of participants with dose limiting toxicities (DLTs) per dose level
Up to 28 days
Part 1: Number of participants with treatment emergent serious adverse events (TESAEs) and treatment emergent adverse events (TEAEs) by severity per dose level
Up to approximately 33 months
Part 1: Number of participants with TESAEs and TEAEs by severity per dose level during DLT observation period
Up to 28 days
Part 1: Number of participants with dosage modifications due to TEAEs per dose level
Up to approximately 33 months
Part 2: Objective Response Rate (ORR)
Up to approximately 33 months

ORR is defined as percentage of participants with confirmed complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1) by investigator assessment.

Secondary Endpoints
Part 1: Plasma concentrations for GSK5460025
Up to approximately 36 months
Part 1: Area under the concentration-time curve (AUC) for GSK5460025
Up to approximately 36 months
Part 1: Maximum concentration (Cmax) for GSK5460025
Up to approximately 36 months
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Part 1: Dose escalation of GSK5460025 monotherapyEXPERIMENTALParticipants will receive GSK5460025 as monotherapy.
Part 2: Dose expansion of GSK5460025 monotherapyEXPERIMENTALParticipants will receive GSK5460025 as monotherapy.
Interventions
NameTypeDescription
GSK5460025DRUGGSK5460025 will be administered
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites13

Inclusion Criteria: * Has a histologically diagnosed advanced (unresectable, metastatic or recurrent) solid tumor * Has a known dMMR/MSI-H status as determined by a certified local laboratory at the time of Pre-screening or has an unknown Mismatch repair (MMR)/ Microsatellite Instability (MSI) stat...

Countries:United StatesCanadaJapanNetherlandsSpain
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Recent Changes (Last 90 Days)
LOWJun 5, 2026NCT07213609lastUpdatePostDate: changed
LOWJun 5, 2026NCT07213609lastUpdatePostDate: changed
LOWJun 5, 2026NCT07213609lastUpdatePostDate: changed
LOWJun 5, 2026NCT07213609lastUpdatePostDate: changed
LOWMay 26, 2026NCT07213609primaryCompletionDate: changed
LOWMay 24, 2026NCT07213609studyFirstPostDate: changed