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GS-9911

Phase 1

Solid Tumors | Small molecule | Oncology |Gilead Sciences, Inc.|Last Updated: Apr 16, 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 Enrollment45
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06082960Study of GS-9911 With or Without Antibody Treatment for Adults With Solid TumorsPHASE1 ACTIVE NOT_RECRUITING 45Oct 9, 2023Dec 1, 2026Apr 16, 20266 United States, Australia +1
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Study Endpoints
Primary Endpoints
Percentage of Participants With Treatment-emergent Adverse Events
First dose date up to 90 days post last dose (up to 105 weeks)
Percentage of Participants With Treatment-emergent Serious Adverse Events
First dose date up to 90 days post last dose (up to 105 weeks)
Percentage of Participants Experiencing any Dose-limiting Toxicities (DLTs) in Dose-escalation Cohorts
First dose date up to 3 weeks
Secondary Endpoints
Plasma Concentration of GS-9911
Predose up to end of treatment (up to 105 weeks)
Pharmacokinetic (PK) Parameter: Cmax of GS-9911
Predose up to end of treatment (up to 105 weeks)
PK Parameter: Tmax of GS-9911
Predose up to end of treatment (up to 105 weeks)
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Part A: GS-9911 Monotherapy Dose EscalationEXPERIMENTALParticipants will receive escalating doses of GS-9911 monotherapy.
Part B: GS-9911 Monotherapy Dose ExpansionEXPERIMENTALParticipants will receive GS-9911 monotherapy at the recommended dose for expansion (RDE) determined in Part A.
Part C: Dose Escalation: GS-9911 + Anti-PD-1 Monoclonal AntibodyEXPERIMENTALParticipants will receive escalating doses of GS-9911 in combination with an anti-PD-1 monoclonal antibody (zimberelimab).
Part D: Dose Expansion: GS-9911 + Anti-PD-1 Monoclonal AntibodyEXPERIMENTALParticipants will receive GS-9911 at RDE determined in Part C in combination with an anti-PD-1 monoclonal antibody (zimberelimab).
Interventions
NameTypeDescription
GS-9911DRUGTablets administered orally
ZimberelimabDRUGAdministered intravenously
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites6

Key Inclusion Criteria: * Parts A, C, and D: * Participants with histologically or cytologically confirmed advanced solid tumors who have received, been intolerant to, or are ineligible for all treatments known to confer clinical benefit * Part B: * Participants whose cancer previously derive...

Countries:United StatesAustraliaCanada
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06082960primaryCompletionDate: changed
LOWMay 24, 2026NCT06082960studyFirstPostDate: changed