Recent Updates
Recently added Catalysts

GSK5533524

Phase 1

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

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

CONTROLLED
Total Trials1
Total Enrollment97

FDA Designations

No designations recorded

Clinical trial landscape

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
Unlock Study Endpoints

Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part 1a: GSK5533524 Dose Escalation & BackfillEXPERIMENTAL -
Part 1b: GSK5533524 Dose ExpansionEXPERIMENTAL -

Interventions

NameTypeDescription
GSK5533524DRUGGSK5533524 will be administered.
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites16

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 to standard therapy, for which no standard treatment is available, or who is intolerant to established standard of care th...

Countries:United StatesCanadaFinlandJapanSpainUnited Kingdom
Unlock Eligibility Criteria

Recent Changes (Last 90 Days)

LOWJul 21, 2026NCT07438782lastUpdatePostDate: changed

Frequently asked questions about GSK5533524

What is GSK5533524 used for?

GSK5533524 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 adult participants with advanced solid tumors as part of a first-in-human clinical trial.

Who makes GSK5533524?

GSK5533524 is being developed by GSK plc, a global biopharma company listed on the London Stock Exchange under the ticker GSK. The company is conducting a Phase 1 clinical trial to evaluate the safety and preliminary activity of the drug in patients with advanced solid tumors.

What phase is GSK5533524 in?

GSK5533524 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being tested in clinical trials to assess its safety and preliminary activity in patients with advanced solid tumors.

What clinical trials is GSK5533524 in?

GSK5533524 is being studied in a single Phase 1 trial with the identifier NCT07438782. This first-in-human study is investigating the safety and preliminary activity of GSK5533524 alone or in combination in adult participants with advanced solid tumors. The trial is currently recruiting participants.

Where is the GSK5533524 clinical trial being conducted?

The GSK5533524 Phase 1 clinical trial is being conducted in multiple countries, including the United States, Canada, Finland, Japan, Spain, and the United Kingdom. The study enrolls adults aged 18 years and older with advanced solid tumors, and it is currently recruiting participants.