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GS-2121

Phase 1

Advanced Solid Tumors | Small molecule | Oncology |Gilead Sciences, Inc.|Last Updated: Apr 21, 2026

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment154

FDA Designations

No designations recorded

Clinical trial landscape

GS-2121 · 1 trial · 1 indication

Phase 1 1
NCT06532565Study of GS-2121 Given Alone or in Combination in Adults With Advanced Solid TumorsAdvanced Solid Tumors
RECRUITING154 Analytics
PHASE1RECRUITING
Study of GS-2121 Given Alone or in Combination in Adults With Advanced Solid Tumors
Advanced Solid TumorsUnlock trial analytics

Study Endpoints

Primary Endpoints

Parts A and B: Percentage of Participants with Adverse Events and Serious Adverse Events
First dose up to 90 days post last dose (up to approximately 118 weeks)
Parts A and B: Percentage of Participants with Laboratory Abnormalities
First dose up to 90 days post last dose (up to approximately 118 weeks)
Part A: Percentage of Participants with Dose-Limiting Toxicities (DLTs) During Dose Escalation
Day 1 up to Day 21

DLTs are defined as any of the protocol-specified treatment-emergent adverse events (AEs) with onset within the DLT-evaluation period for the corresponding dose.

Parts C and D: Percentage of Participants with Adverse Events and Serious Adverse Events
First dose up to 90 days post last dose (up to approximately 118 weeks)
Parts C and D: Percentage of Participants with Laboratory Abnormalities
First dose up to 90 days post last dose (up to approximately 118 weeks)
Part C: Percentage of Participants with DLTs During Dose Escalation
Day 1 up to Day 21

DLTs are defined as any of the protocol-specified treatment-emergent adverse events (AEs) with onset within the DLT-evaluation period for the corresponding dose.

Secondary Endpoints

Parts A and B: Plasma Concentration of GS-2121 and Active Metabolite
Predose and postdose up to end of treatment (up to 105 weeks)
Parts A and B: PK Parameter: AUC0-24 of GS-2121
Predose and postdose up to end of treatment (up to 105 weeks)
Parts A and B: PK Parameter: Cmax of GS-2121
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
Part A: GS-2121 Monotherapy Dose EscalationEXPERIMENTALParticipants will receive escalating doses of GS-2121 monotherapy until disease progression, or until the participant meets other study drug discontinuation criteria as specified in protocol.
Part B: GS-2121 Monotherapy Dose ExpansionEXPERIMENTALParticipants with selected indications will receive GS-2121 monotherapy at the recommended dose for expansion.
Part C: Combination Dose Escalation of GS-2121 with ZimberelimabEXPERIMENTALParticipants will receive escalating doses of GS-2121 in combination with zimberelimab until disease progression, or until the participant meets other study drug discontinuation criteria as specified in protocol.
Part D: Combination Dose Expansion of GS-2121 with ZimberelimabEXPERIMENTALParticipants with selected indications will receive GS-2121 at the recommended dose for expansion in combination with zimberelimab.

Interventions

NameTypeDescription
GS-2121DRUGTablet administered orally
ZimberelimabDRUGAdministered intravenously
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Eligibility Criteria

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

Key Inclusion Criteria: * Participants diagnosed with histologically or cytologically confirmed advanced solid tumors who have progressed despite standard therapy, are intolerant to standard therapy, or are ineligible for standard therapy. * Measurable disease per Response Evaluation Criteria in So...

Countries:United StatesCanada
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Competitive Landscape -Other Solid Tumors 9 trials (matched to "Advanced Solid Tumors")

Frequently asked questions about GS-2121

What is GS-2121 used for?

GS-2121 is an investigational small molecule being developed for the treatment of advanced solid tumors. It is currently in Phase 1 clinical development, meaning it has not yet been approved by regulatory authorities and is still being studied for safety and efficacy in patients.

Who makes GS-2121?

GS-2121 is being developed by Gilead Sciences, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol GILD. The company is sponsoring a Phase 1 clinical trial to evaluate the drug in adults with advanced solid tumors.

What phase is GS-2121 in?

GS-2121 is in Phase 1 clinical development. It is an investigational drug, meaning it is not yet approved for any use. The ongoing Phase 1 trial is recruiting participants to study the drug given alone or in combination in adults with advanced solid tumors.

What clinical trials is GS-2121 in?

GS-2121 is being studied in one active Phase 1 clinical trial with the identifier NCT06532565. This trial is titled 'Study of GS-2121 Given Alone or in Combination in Adults With Advanced Solid Tumors' and is currently recruiting participants in the United States and Canada.

Is GS-2121 the same as any other drug?

No alternative names for GS-2121 have been reported. The drug is identified solely by its code name GS-2121 in clinical trial records and by its developer, Gilead Sciences.