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GSK4524101

Phase 1

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

GSK4524101 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Oct 2023

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment42

FDA Designations

No designations recorded

GSK4524101 clinical trials

GSK4524101 · 1 trial · 1 indication

Phase 1 1
NCT06077877A Study to Investigate the Safety, Tolerability, Pharmacokinetics (PK), and Preliminary Anticancer Activity of GSK4524101 Alone or With Niraparib in Participants With Solid TumorsNeoplasms
ACTIVE NOT_RECRUITING42 Analytics
PHASE1ACTIVE NOT_RECRUITING
A Study to Investigate the Safety, Tolerability, Pharmacokinetics (PK), and Preliminary Anticancer Activity of GSK4524101 Alone or With Niraparib in Participants With Solid Tumors
NeoplasmsUnlock trial analytics

Study Endpoints

Primary Endpoints

Part 1 - Proportion of Participants with Dose Limiting Toxicities (DLTs) during DLT Observation Period
Up to 28 days
Part 1 - Proportion of Participants with Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) based on Severity during DLT Observation Period
Up to 28 days
Part 1 - Duration of Treatment Emergent AEs and SAEs (Days) during DLT Observation Period
Up to 28 days
Part 1 - Percentage of Participants who receive all Planned Doses during DLT Observation Period
Up to 28 days
Part 1 -Percentage of Participants who require dosage interruptions, dose reductions, and drug discontinuations due to adverse reactions during DLT Observation Period
Up to 28 days
Part 2 - Confirmed Objective Response Rate (ORR)
Up to approximately 52 weeks

ORR is the percentage of participants with an Investigator-assessed confirmed complete response and confirmed partial response to treatment, as assessed by Response Evaluation Criteria in Solid Tumor (RECIST) v1.1

Secondary Endpoints

Part 1 - Area Under Curve (AUC) of GSK4364973 (Metabolite of GSK4524101)
Up to 21 weeks
Part 1 -Maximum Concentration (Cmax) of GSK4364973 (Metabolite of GSK4524101)
Up to 21 weeks
Part 1 - Time to Maximum Concentration of GSK4364973 (Metabolite of GSK4524101)
Up to 21 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part 1 - GSK4524101 MonotherapyEXPERIMENTAL -
Part 1 - GSK4524101 plus NiraparibEXPERIMENTAL -
Part 1 - GSK4524101 Food Effect CohortEXPERIMENTAL -
Part 2 - GSK4524101 plus NiraparibEXPERIMENTAL -
Part 2 - NiraparibACTIVE_COMPARATOR -

Interventions

NameTypeDescription
GSK4524101DRUGGSK452101 will be administered.
NiraparibDRUGNiraparib will be administered.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites11

Inclusion Criteria: * More than or equal to (≥)18 years of age * Eastern cooperative oncology group (ECOG) class 0-2 * Life expectancy of a minimum of 3 month * Participant has histologically diagnosed advanced or metastatic solid tumor and has exhausted all standard of care treatment options (Part...

Countries:United StatesCanadaPanama
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Frequently asked questions about GSK4524101

What is GSK4524101?

GSK4524101 is an investigational small molecule being developed by GSK plc for the treatment of solid tumors. It is in Phase 1 clinical development and is being studied both as a monotherapy and in combination with niraparib in participants with neoplasms.

What is GSK4524101 used for?

GSK4524101 is being studied for the treatment of neoplasms, specifically solid tumors. It is not yet approved for any indication and remains an investigational therapy in Phase 1 clinical development.

Who makes GSK4524101?

GSK4524101 is being developed by GSK plc, which trades under the ticker GSK. The company is the sponsor of the Phase 1 clinical trial evaluating the drug in participants with solid tumors.

What phase is GSK4524101 in?

GSK4524101 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency for any indication.

What clinical trials is GSK4524101 in?

GSK4524101 is being evaluated in one active clinical trial, NCT06077877, titled a study to investigate the safety, tolerability, pharmacokinetics, and preliminary anticancer activity of GSK4524101 alone or with niraparib in participants with solid tumors. The trial is active but not recruiting, with an enrollment of 42 participants across the United States, Canada, and Panama.

Is GSK4524101 biomarker-selected?

Yes, the Phase 1 trial NCT06077877 for GSK4524101 is biomarker-selected, meaning participants are enrolled based on specific biomarker criteria. The study is randomized and active-controlled, evaluating the drug alone or in combination with niraparib in adults with solid tumors.