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GSK4418959

Phase 1

Neoplasms, Colorectal | Small molecule | Oncology |GSK plc|Last Updated: Feb 2, 2026

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment14

FDA Designations

No designations recorded

Clinical trial landscape

GSK4418959 · 1 trial · 5 indications

Phase 1 1
NCT06710847A Study to Investigate the Safety, Pharmacokinetics, and Preliminary Effectiveness of GSK4418959 Alone or in Combination With Other Anti-cancer Agents in Participants With Solid TumorsNeoplasms, Colorectal
ACTIVE NOT_RECRUITING14 Analytics
PHASE1ACTIVE NOT_RECRUITING
A Study to Investigate the Safety, Pharmacokinetics, and Preliminary Effectiveness of GSK4418959 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) during DLT observation period
Up to 21 days
Part 3: Number of participants with dose limiting toxicities (DLTs) during DLT observation period
Up to 21 days
Part 1: Number of participants with treatment emergent adverse events (TEAEs) during DLT observation period
Up to 21 days
Part 3: Number of participants with treatment emergent adverse events (TEAEs) during DLT observation period
Up to 21 days
Part 1: Number of participants with dosage interruptions, dose reductions, and drug discontinuations for TEAEs during DLT observation period
Up to 21 days
Part 3: Number of participants with dosage interruptions, dose reductions, and drug discontinuations for TEAEs during DLT observation period
Up to 21 days
Part 2: Objective Response Rate (ORR)
Up to approximately 26 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: Area under the concentration-time curve (AUC) for GSK4418959
From first day of dosing for the duration of treatment until end of interventional phase (EOI) (up to approximately 42 months)
Part 1: Maximum concentration (Cmax) for GSK4418959
From first day of dosing for the duration of treatment until end of interventional phase (EOI) (up to approximately 42 months)
Part 1: Time to maximum concentration (Tmax) for GSK4418959
From first day of dosing for the duration of treatment until end of interventional phase (EOI) (up to approximately 42 months)
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part 1: Dose escalation of GSK4418959 monotherapyEXPERIMENTALParticipants will receive GSK4418959 as monotherapy.
Part 2: Dose expansion of GSK4418959 monotherapyEXPERIMENTALParticipants will receive GSK4418959 as monotherapy.
Part 3: Dose escalation of GSK4418959 plus PD-1 inhibitorEXPERIMENTALParticipants will receive GSK4418959 plus PD-1 inhibitor.

Interventions

NameTypeDescription
GSK4418959DRUGGSK4418959 will be administered.
PD-1 inhibitorBIOLOGICALPD-1 inhibitor will be administered.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites22

Inclusion Criteria: Parts 1, 2, and 3 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)...

Countries:United StatesAustraliaBelgiumJapanNetherlandsSouth KoreaSpain
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Frequently asked questions about GSK4418959

What is GSK4418959 used for?

GSK4418959 is an investigational small molecule being developed for the treatment of solid tumors, including colorectal cancer, colon cancer, rectal cancer, and endometrial cancer. It is currently in Phase 1 clinical development for these oncology indications.

Who makes GSK4418959?

GSK4418959 is being developed by GSK plc, a global biopharma company listed on the stock exchange under the ticker GSK. The company is conducting clinical trials to evaluate the safety and effectiveness of this investigational drug.

What phase is GSK4418959 in?

GSK4418959 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials to assess its safety, pharmacokinetics, and preliminary effectiveness in patients with solid tumors.

What clinical trials is GSK4418959 in?

GSK4418959 is being studied in a Phase 1 clinical trial registered as NCT06710847. This trial investigates the drug alone or in combination with other anti-cancer agents in participants with solid tumors, including colorectal, colon, rectal, and endometrial cancers. The trial is active but not recruiting participants.

How does GSK4418959 work?

GSK4418959 is a small molecule drug. Its specific molecular target has not been disclosed in the available information, so its exact mechanism of action is not publicly detailed. It is being studied for its potential anti-cancer effects in solid tumors.