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Remzistotug

Phase 1

Neoplasms | 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
CONTROLLEDBiomarker
Total Trials1
Total Enrollment152
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05277051First-Time-in-Human Study of GSK4381562 in Participants With Advanced Solid TumorsPHASE1 ACTIVE NOT_RECRUITING 152Mar 22, 2022Aug 31, 2027May 22, 202626 United States, Australia +7
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Study Endpoints
Primary Endpoints
Arms A, B, C, I: Number of Participants with dose-limiting toxicities (DLTs)
Up to 21 days
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Up to 27 months
Secondary Endpoints
Number of Participants With Clinically Significant Changes in Laboratory Parameters, Electrocardiogram (ECG) and Vital Signs
Up to 24 months
Number of Participants With Dose Reductions or Delays
Up to 24 months
Number of Participants With Withdrawals due to AEs
Up to 27 months
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Participants Receiving remzistotug Monotherapy (Arm A)EXPERIMENTAL -
Participants Receiving remzistotug Plus Dostarlimab (Arm B)EXPERIMENTAL -
Participants Receiving remzistotug Plus Dostarlimab Plus belrestotug (Arm C)EXPERIMENTAL -
Participants Receiving Dostarlimab Plus belrestotug (Arm D)EXPERIMENTAL -
Participants Receiving dostarlimab Plus belrestotug Plus remzistotug (Arm E)EXPERIMENTAL -
Participants Receiving dostarlimab Plus belrestotug Plus nelistotug (Arm F)EXPERIMENTAL -
China Cohort: Participants receiving dostarlimab (Arm G)EXPERIMENTAL -
Participants Receiving GSK5764227 Plus dostarlimab (Arm I)EXPERIMENTAL -
Interventions
NameTypeDescription
RemzistotugDRUGRemzistotug will be administered.
DostarlimabDRUGDostarlimab will be administered.
BelrestotugDRUGBelrestotug will be administered.
NelistotugDRUGNelistotug will be administered.
GSK5764227DRUGGSK5764227 will be administered.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites26

Inclusion criteria: * A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least 1 of the following conditions applies: * Is not a woman of childbearing potential (WOCBP) or * Is a WOCBP and using a contraceptive method that is highly effective with a...

Countries:United StatesAustraliaCanadaChinaFranceJapanSouth KoreaSpainUnited Kingdom
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Recent Changes (Last 90 Days)
MEDIUMMay 26, 2026NCT05277051Status: RECRUITING → ACTIVE_NOT_RECRUITING
LOWMay 24, 2026NCT05277051studyFirstPostDate: changed