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GSK5460025

Phase 1

Neoplasms, Colorectal | Small molecule | Oncology |GSK plc|Last Updated: Jul 21, 2026

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment47

FDA Designations

No designations recorded

Clinical trial landscape

GSK5460025 · 1 trial · 2 indications

Phase 1 1
NCT07213609A Study to Investigate the Safety and Preliminary Efficacy of GSK5460025 Alone or in Combination With Other Anti-cancer Agents in Participants With Solid TumorsNeoplasms, Colorectal
RECRUITING47 Analytics
PHASE1RECRUITING
A Study to Investigate the Safety and Preliminary Efficacy of GSK5460025 Alone or in Combination With Other Anti-cancer Agents in Participants With Solid Tumors
Neoplasms, ColorectalUnlock trial analytics

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 to N/A
SexALL
Healthy VolunteersNo
Study Sites22

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 StatesCanadaDenmarkJapanNetherlandsSpainSweden
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Recent Changes (Last 90 Days)

LOWJul 21, 2026NCT07213609lastUpdatePostDate: changed
LOWJun 18, 2026NCT07213609lastUpdatePostDate: changed
LOWJun 18, 2026NCT07213609lastUpdatePostDate: changed
LOWJun 18, 2026NCT07213609lastUpdatePostDate: changed

Frequently asked questions about GSK5460025

What is GSK5460025 used for?

GSK5460025 is an investigational small molecule being studied for the treatment of solid tumors, including colorectal neoplasms. It is currently in Phase 1 clinical development for oncology indications. The drug is being evaluated alone and in combination with other anti-cancer agents in patients with solid tumors.

Who makes GSK5460025?

GSK5460025 is being developed by GSK plc, a global biopharmaceutical company. GSK plc is listed on the stock exchange under the ticker symbol GSK. The company is conducting clinical trials to investigate the safety and preliminary efficacy of this investigational oncology drug.

What phase is GSK5460025 in?

GSK5460025 is currently in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The ongoing Phase 1 trial is recruiting participants to evaluate the safety and preliminary efficacy of GSK5460025 in patients with solid tumors.

What clinical trials is GSK5460025 in?

GSK5460025 is being studied in a Phase 1 clinical trial registered as NCT07213609. This trial is investigating the safety and preliminary efficacy of GSK5460025 alone or in combination with other anti-cancer agents in participants with solid tumors. The trial is currently recruiting and aims to enroll 47 participants.

What does GSK5460025 target?

The specific molecular target of GSK5460025 has not been disclosed in publicly available information. The drug is being studied for its potential anti-cancer activity in solid tumors, including colorectal neoplasms. Further details about its mechanism of action are not yet available from the clinical trial data.