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GSK5533524

Phase 1

Neoplasms | Small molecule | Oncology |GSK plc|Last Updated: May 27, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDBiomarker
Total Trials1
Total Enrollment97
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
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 TumorsPHASE1 RECRUITING 97Mar 23, 2026Feb 6, 2029May 27, 20268 United States, Canada +1
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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 Escalation & BackfillEXPERIMENTAL -
Part 1b: GSK5533524 Dose ExpansionEXPERIMENTAL -
Interventions
NameTypeDescription
GSK5533524DRUGGSK5533524 will be administered.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites8

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 StatesCanadaJapan
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Recent Changes (Last 90 Days)
LOWMay 28, 2026NCT07438782primaryCompletionDate: changed
LOWMay 28, 2026NCT07438782primaryCompletionDate: changed
LOWMay 26, 2026NCT07438782Status: NOT_YET_RECRUITING → RECRUITING
LOWMay 24, 2026NCT07438782studyFirstPostDate: changed