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GS-9911

Phase 1

Solid Tumors | Small molecule | Oncology |Gilead Sciences, Inc.|Last Updated: Apr 16, 2026

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment45

FDA Designations

No designations recorded

Clinical trial landscape

GS-9911 · 1 trial · 1 indication

Phase 1 1
NCT06082960Study of GS-9911 With or Without Antibody Treatment for Adults With Solid TumorsSolid Tumors
ACTIVE NOT_RECRUITING45 Analytics
PHASE1ACTIVE NOT_RECRUITING
Study of GS-9911 With or Without Antibody Treatment for Adults With Solid Tumors
Solid TumorsUnlock trial analytics

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 to 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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Competitive Landscape -Other Solid Tumors 9 trials (matched to "Solid Tumors")

Frequently asked questions about GS-9911

What is GS-9911 used for?

GS-9911 is an investigational small molecule being developed for the treatment of solid tumors. It is currently in Phase 1 clinical development, with an active trial studying its use alone or in combination with an antibody treatment in adults with solid tumors.

Who makes GS-9911?

GS-9911 is being developed by Gilead Sciences, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol GILD. The company is conducting a Phase 1 clinical trial to evaluate the drug in patients with solid tumors.

What phase is GS-9911 in?

GS-9911 is in Phase 1 clinical development. It is an investigational drug, not yet approved by regulatory authorities, and is being studied in an active clinical trial for the treatment of solid tumors in adults.

What clinical trials is GS-9911 in?

GS-9911 is being studied in a Phase 1 clinical trial with the identifier NCT06082960. This trial is titled 'Study of GS-9911 With or Without Antibody Treatment for Adults With Solid Tumors' and is currently active but not recruiting participants.

Is GS-9911 the same as any other drug?

No alternative names for GS-9911 have been disclosed. The drug is identified by its code name GS-9911 in clinical trial registrations and is being developed by Gilead Sciences for the treatment of solid tumors.