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GSK5533524

Phase 1

Neoplasms | Small molecule | Oncology |GSK plc|Trials Updated: Sep 25, 2026

GSK5533524 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Feb 2026

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment97

FDA Designations

No designations recorded

GSK5533524 clinical trials

GSK5533524 · 1 trial · 1 indication

Phase 1 1
NCT07438782First Time in Human (FTIH) Study to Investigate the Safety and Preliminary Activity of GSK5533524 Alone or in Combination in Adult Participants With Advanced Solid TumorsNeoplasms
RECRUITING97 Analytics
PHASE1RECRUITING
First Time in Human (FTIH) Study to Investigate the Safety and Preliminary Activity of GSK5533524 Alone or in Combination in Adult Participants With Advanced Solid Tumors
NeoplasmsUnlock trial analytics

Study Endpoints

Primary Endpoints

Part 1a: Number of participants with dose limiting toxicities (DLTs) per dose level
Up to 21 days
Part 1a: Number of participants with adverse events (AEs), serious adverse events (SAEs), by Severity per dose level
Up to approximately 34 months
Part 1b: Objective Response Rate (ORR)
Up to approximately 27 months

ORR is defined as the proportion of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).

Secondary Endpoints

Part 1a & 1b: Number of participants with adverse events (AEs), serious adverse events (SAEs), Treatment-Emergent AEs (TEAEs) by severity, Adverse Events of Special Interest (AESIs), and AEs leading to dose modifications and treatment discontinuation
Up to approximately 34 months
Part 1a: Objective Response Rate (ORR)
Up to approximately 27 months
Part 1a & 1b: Duration of Response (DoR)
Up to approximately 27 months
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part 1a: GSK5533524 Dose EscalationEXPERIMENTAL -
Part 1b: GSK5533524 Dose ExpansionEXPERIMENTAL -

Interventions

NameTypeDescription
GSK5533524DRUGGSK5533524 will be administered.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites20

Inclusion Criteria: * Is at least 18 years of age or the legal age of consent * Has histologically or cytologically confirmed advanced/metastatic solid tumor that is refractory or intolerant to standard therapy, has exhausted all treatment options and is not considered a candidate for definitive ra...

Countries:United StatesCanadaDenmarkFinlandFranceJapanSpainUnited Kingdom
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Recent Changes (Last 90 Days)

LOWSep 25, 2026NCT07438782lastUpdatePostDate: changed
LOWSep 25, 2026NCT07438782lastUpdatePostDate: changed
LOWJul 21, 2026NCT07438782lastUpdatePostDate: changed

Frequently asked questions about GSK5533524

What is GSK5533524?

GSK5533524 is an investigational small molecule developed by GSK plc for the treatment of advanced solid tumors. It is being studied in a first-time-in-human Phase 1 clinical trial in adult participants with neoplasms. GSK5533524 has not been approved by any regulatory authority and remains in clinical development.

What is GSK5533524 used for?

GSK5533524 is being evaluated for the treatment of advanced solid tumors, also described as neoplasms, in adult patients. The Phase 1 study enrolls participants aged 18 years and older with advanced solid tumors. Its use remains investigational, and no approved indication currently exists for this drug.

Who is developing GSK5533524?

GSK5533524 is developed by GSK plc, which trades under the ticker GSK. The company is running the first-time-in-human study of the small molecule in adult participants with advanced solid tumors across sites in the United States, Canada, Denmark, Finland, France, Japan, Spain, and the United Kingdom.

What phase is GSK5533524 in?

GSK5533524 is in Phase 1 clinical development. It is being tested in a first-time-in-human study designed to investigate safety and preliminary activity in adult participants with advanced solid tumors. The drug is investigational and has not received FDA approval.

What clinical trials is GSK5533524 in?

GSK5533524 is being studied in one active clinical trial, NCT07438782, titled a first-time-in-human study to investigate the safety and preliminary activity of GSK5533524 alone or in combination in adult participants with advanced solid tumors. The trial is currently recruiting and plans to enroll 97 participants.

How is the GSK5533524 trial designed?

The Phase 1 trial NCT07438782 is a controlled, non-randomized, open-label study of GSK5533524 given alone or in combination in adults with advanced solid tumors. It plans to enroll 97 participants aged 18 years and older, including all sexes, and is recruiting across eight countries.