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GSK6097608

Phase 1

Neoplasms | Small molecule | Oncology |GSK plc|Last Updated: Oct 27, 2025

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 Enrollment107
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04446351Study of the Safety and Effectiveness of GSK6097608 in Participants With Advanced Solid TumorsPHASE1 ACTIVE NOT_RECRUITING 107Jun 25, 2020Dec 31, 2026Oct 27, 202511 United States, Canada +2
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Study Endpoints
Primary Endpoints
Number of participants with dose-limiting toxicities (DLTs)
Up to Day 21
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Up to 2 years
Secondary Endpoints
Number of participants with clinically significant changes in laboratory parameters, vital signs, and 12-lead electrocardiogram (ECG) findings
Up to 2 years
Number of participants with dose reductions or delay
Up to 2 years
Number of participants withdrawn due to AEs
Up to 2 years
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Participants receiving GSK6097608 monotherapy (Arm A)EXPERIMENTALParticipants will be administered an intravenous (IV) infusion of GSK6097608 every 3 weeks as monotherapy in escalating doses.
Participants receiving GSK6097608 plus dostarlimab (Arm B)EXPERIMENTALParticipants will be administered IV infusion of GSK6097608 every 3 weeks in escalating doses followed by dostarlimab.
Participants receiving dostarlimab monotherapy (Arm D)EXPERIMENTALParticipants will be administered an IV infusion of dostarlimab monotherapy (1 cohort will receive dostarlimab every 3 weeks and 1 cohort will receive dostarlimab every 6 weeks).
Participants receiving dostarlimab plus belrestotug (Arm E)EXPERIMENTALParticipants will be administered IV infusions of dostarlimab followed by belrestotug, every 3 weeks.
Participants receiving dostarlimab plus belrestotug plus GSK6097608 (Arm F)EXPERIMENTALParticipants will be administered an IV infusion of dostarlimab followed by belrestotug followed by GSK6097608 every 3 weeks.
Participants receiving dostarlimab plus cobolimab (Arm G)EXPERIMENTALParticipants will be administered an IV infusion of cobolimab followed by dostarlimab
Interventions
NameTypeDescription
GSK6097608DRUGGSK6097608 will be administered as an IV infusion.
DostarlimabDRUGDostarlimab will be administered as an IV infusion.
CobolimabDRUGCobolimab will be administered as an IV infusion.
BelrestotugDRUGBelrestotug will be administered as an IV infusion.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites11

Inclusion Criteria: * Adults 18 years of age or older (or \>=20 years of age in Arm-A Japan, Arm-D Japan, Arm E-Japan, Arm F-Japan, and Arm G-Japan) * Female participants of childbearing potential must agree to use a highly effective form of contraception * Histological or cytological documentation...

Countries:United StatesCanadaJapanSouth Korea
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT04446351primaryCompletionDate: changed
LOWMay 24, 2026NCT04446351studyFirstPostDate: changed