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GSK5733584

Phase 1

Solid Tumors | Small molecule | Oncology |GSK plc|Last Updated: May 22, 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
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment675
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06431594A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Clinical Activity of GSK5733584 for Injection in Participants With Advanced Solid TumorsPHASE1 RECRUITING 675Jul 2, 2024Dec 31, 2029May 22, 202665 United States, Argentina +13
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Study Endpoints
Primary Endpoints
Part 1: Number of participants with dose limiting toxicity (DLT)
Up to 21 days
Part 2: Confirmed Objective Response Rate (ORR)
Up to approximately 28 months

ORR is defined as the proportion of participants with at least one confirmed Complete Response (CR) or Partial Response (PR) as defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.1)

Secondary Endpoints
Part 1 and 2: Maximum observed concentration (Cmax) of GSK5733584 and its components: conjugated antibody, total antibody, and small molecule toxin
Up to approximately 31 months
Part 1 and 2: Time to reach Cmax (Tmax) of GSK5733584 and its components: conjugated antibody, total antibody, and small molecule toxin
Up to approximately 31 months
Part 1 and 2: Area under the concentration-time curve (AUC) of GSK5733584 and its components: conjugated antibody, total antibody, and small molecule toxin
Up to approximately 31 months
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Part 1: Dose EscalationEXPERIMENTALParticipants with advanced solid tumors who are refractory or intolerant to established standard therapies
Part 2: Dose ExpansionEXPERIMENTALParticipants with platinum-resistant ovarian cancer (PROC) and endometrial cancer (EC)
Interventions
NameTypeDescription
GSK5733584DRUGGSK5733584 will be administered
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites65

Inclusion Criteria: * Males or females aged 18 years or older (≥18 years). * Participants with pathologically confirmed advanced solid tumor (who have failed or are intolerant to standard of care). * PROC cohort 1. Histologically documented, advanced (metastatic and/or unresectable) high-grade s...

Countries:United StatesArgentinaAustraliaBelgiumBrazilCanadaFinlandFranceItalyJapanNetherlandsSouth KoreaSpainSwedenUnited Kingdom
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Recent Changes (Last 90 Days)
MEDIUMMay 26, 2026NCT06431594Enrollment: 385 → 675
LOWMay 24, 2026NCT06431594studyFirstPostDate: changed