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GS-2426

Phase 1

Advanced Solid Tumors | Small molecule | Oncology |Gilead Sciences, Inc.|Trials Updated: Oct 14, 2026

GS-2426 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since May 2026

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDBiomarker
Total Trials1
Total Enrollment174

FDA Designations

No designations recorded

GS-2426 clinical trials

GS-2426 · 1 trial · 1 indication

Phase 1 1
NCT07601243Study of GS-2426 in Participants With Advanced Solid TumorsAdvanced Solid Tumors
RECRUITING174 Analytics
PHASE1RECRUITING
Study of GS-2426 in Participants With Advanced Solid Tumors
Advanced Solid TumorsUnlock trial analytics

Study Endpoints

Primary Endpoints

Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAE)
First dose up to 30 days post last dose (up to 105 weeks)
Percentage of Participants Experiencing Clinical Laboratory Abnormalities
First dose up to 30 days post last dose (up to 105 weeks)
Percentage of Participants Experiencing Any Dose-limiting Toxicities (DLTs)
First dose up to 21 days post first dose
Maximum Tolerated Dose (MTD)/Maximum Administered Dose (MAD)
First dose up to 21 days post first dose
Recommended Phase 2 Dose (RP2D)
Predose to end of study (up to 105 weeks)

Secondary Endpoints

Plasma Concentration of GS-2426
Predose and postdose up to end of treatment (up to 105 weeks)
Pharmacokinetic (PK) Parameter: AUC0-24h of GS-2426
Predose and postdose up to end of treatment (up to 105 weeks)
PK Parameters: Cmax of GS-2426
Predose and postdose up to end of treatment (up to 105 weeks)
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Phase 1a: Monotherapy Dose EscalationEXPERIMENTALParticipants will receive escalating doses of GS-2426 monotherapy, until disease progression, or until the participant meets other study drug discontinuation criteria as specified in protocol, or up to a maximum of 105 week, whichever occurs first.
Phase 1b: Monotherapy Dose ExpansionEXPERIMENTALParticipants will be enrolled in different indication-specific cohorts. Participants will receive GS-2426 monotherapy at the recommended dose until disease progression, or until the participant meets other study drug discontinuation criteria as specified in protocol, or up to a maximum of 105 weeks, whichever occurs first.

Interventions

NameTypeDescription
GS-2426DRUGAdministered Orally
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites6

Key Inclusion Criteria: * Participants 18 years of age or older (≥ 19 years old for participants in South Korea). * Histologically or cytologically confirmed advanced malignant solid tumors, who have progressed on, are intolerant to or are ineligible for standard therapy, or have no standard treatm...

Countries:United StatesSpain
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Competitive Landscape -Other Solid Tumors 10 trials (matched to "Advanced Solid Tumors")

Recent Changes (Last 90 Days)

LOWOct 14, 2026NCT07601243lastUpdatePostDate: changed
LOWOct 14, 2026NCT07601243lastUpdatePostDate: changed
LOWAug 3, 2026NCT07601243lastUpdatePostDate: changed
LOWAug 3, 2026NCT07601243lastUpdatePostDate: changed

Frequently asked questions about GS-2426

What is GS-2426?

GS-2426 is an investigational small molecule being developed by Gilead Sciences, Inc. for the treatment of advanced solid tumors. It is currently in Phase 1 clinical development and is a biomarker-selected therapy, meaning trial enrollment is guided by a specific biomarker. GS-2426 has not been approved by the FDA.

What is GS-2426 used for in advanced solid tumors?

GS-2426 is being studied as a treatment for advanced solid tumors in adults 18 years and older. It is an investigational agent in Phase 1 testing and is not approved for any indication. The ongoing trial enrolls participants with advanced solid tumors and uses biomarker selection to identify eligible patients.

Who makes GS-2426?

GS-2426 is being developed by Gilead Sciences, Inc., which trades on the Nasdaq under the ticker GILD. Gilead is the sponsor of the Phase 1 clinical program evaluating GS-2426 in advanced solid tumors. The drug remains investigational and has not received regulatory approval.

What phase is GS-2426 in?

GS-2426 is in Phase 1 clinical development. The single ongoing trial is a Phase 1 study in participants with advanced solid tumors and is currently recruiting. GS-2426 is investigational and has not been approved by the FDA for any use.

What clinical trials is GS-2426 in?

GS-2426 is being evaluated in one Phase 1 trial, NCT07601243, titled Study of GS-2426 in Participants With Advanced Solid Tumors. The trial is recruiting, has an estimated enrollment of 174 participants, and is being conducted in the United States and Spain. It enrolls adults 18 years and older of all sexes.