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GSK4524101

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment42

FDA Designations

No designations recorded

Clinical trial landscape

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 used for?

GSK4524101 is an investigational small molecule being developed for the treatment of neoplasms, which are abnormal growths of tissue that can be benign or malignant. It is currently being studied in a Phase 1 clinical trial in participants with solid tumors, both alone and in combination with niraparib.

What does GSK4524101 target?

The specific molecular target of GSK4524101 has not been disclosed. It is being studied for its potential anticancer activity in solid tumors, and the ongoing clinical trial is evaluating its safety, tolerability, pharmacokinetics, and preliminary efficacy.

Who makes GSK4524101?

GSK4524101 is being developed by GSK plc, a global biopharmaceutical company listed on the stock exchange under the ticker symbol GSK. The company is conducting a Phase 1 clinical trial to investigate the drug's safety and preliminary anticancer activity in participants with solid tumors.

What phase is GSK4524101 in?

GSK4524101 is in Phase 1 of clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied for safety, tolerability, and preliminary efficacy in humans.

What clinical trials is GSK4524101 in?

GSK4524101 is being studied in a Phase 1 clinical trial with the identifier NCT06077877. The trial is investigating 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.

Is GSK4524101 the same as niraparib?

No, GSK4524101 is not the same as niraparib. GSK4524101 is the investigational drug being studied, while niraparib is a separate medication that is being used in combination with GSK4524101 in the clinical trial. The trial is evaluating the effects of GSK4524101 both alone and in combination with niraparib.