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Study of GS-2121 for Advanced Solid Tumors

This study is testing a new drug called GS-2121, given either alone or with another drug called zimberelimab, for adults with advanced solid tumors. This is a "first-in-human" study, meaning it's one of the first times these drugs are being tested in people. The main goals are to understand how safe the drugs are, what side effects they might cause, and to find the best dose. Participants must have advanced solid tumors that have not responded to standard treatments, or they cannot tolerate or are not eligible for standard treatments. You would also need to have measurable disease, meaning the tumor can be seen and measured.

Study design
This is a first-in-human study with a planned enrollment of 154 participants. It is an interventional study, meaning participants will receive a specific treatment.
What's involved
Participants will receive GS-2121 orally (by mouth) or zimberelimab intravenously (through a vein). The study will track side effects and laboratory changes from the first dose up to 90 days after the last dose, which could be up to approximately 118 weeks.
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored for adverse events and laboratory abnormalities from the first dose up to 90 days after the last dose, which could be up to approximately 118 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06532565

Study of GS-2121 Given Alone or in Combination in Adults With Advanced Solid Tumors

Recruiting
PHASE1Ages 18+InterventionalTreatment
Gilead Sciences
~154 participants
Updated 2026-04-21 on ClinicalTrials.gov
What's tested:GS-2121Zimberelimab

At a glance

Recruiting sites
6 of 6 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Parts A and B: Percentage of Participants with Adverse Events and Serious Adverse Events
Measured over First dose up to 90 days post last dose (up to approximately 118 weeks)
+5 more outcomes measured

Conditions

Advanced Solid Tumors

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Solid Neoplasm

NCT06532565

Where you'd take part

This study runs at 6 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Beth Israel Deaconess Medical Center

    Boston, Massachusettsno site contact published

    Recruiting

  • NEXT Oncology

    San Antonio, Texasno site contact published

    Recruiting

  • NEXT Virginia

    Fairfax, Virginiano site contact published

    Recruiting

  • Princess Margaret Cancer Centre

    Toronto, Canadano site contact published

    Recruiting

  • Stanford Cancer Center

    Palo Alto, Californiano site contact published

    Recruiting

  • The Ottawa Hospital Cancer Centre

    Ottawa, Canadano site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Gilead Study Director · STUDY_DIRECTOR · Gilead Sciences

Who to contact

Gilead Clinical Study Information Center
[email protected]
1-833-445-3230 (GILEAD-0)
Email the study team

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Eligibility criteria

Inclusion

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 Solid Tumors (RECIST) v1.1 criteria.
Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1.
Tissue requirements:
Adequate organ function.

Exclusion

Positive serum pregnancy test or participant who is breastfeeding.
Requirement for ongoing therapy with any prohibited medications.
Any anti-cancer therapy, whether investigational or approved within protocol specified time prior to initiation of study including: major surgery (\<4 weeks), experimental therapy (\<21 days or \<5 half-lives whichever is shorter), approved immunotherapy or biologic therapy (\<28 days), approved chemotherapy (\<21 days or \<42 days for mitomycin or nitrosoureas), approved targeted small molecule therapy (\<14 days or \<5 half-lives whichever is longer), hormonal therapy or other adjunctive therapy for cancers other than cancer under evaluation in this study (\<14 days) or radiation therapy (\<21 days).
Any prior allogeneic tissue/solid organ transplantation, including allogeneic stem cell transplantation.
Have not recovered (ie, returned to Grade 1 or baseline) from AEs due to a previously administered agent.
Have known active central nervous system (CNS) metastases and/or leptomeningeal disease (LMD).
Diagnosis of immunodeficiency, either primary or acquired.
History of autoimmune disease or active autoimmune disease that has required systemic treatment within 2 years prior to the start of study treatment.
Have an active second malignancy.
Active and clinically relevant bacterial, fungal, or viral infection that is not controlled or requires systemic antibiotics, antifungals, or antivirals, respectively.
History of pneumonitis requiring treatment with corticosteroids, interstitial lung disease, or severe radiation pneumonitis (excluding localized radiation pneumonitis).
Ascites or pleural effusion that is symptomatic and/or requiring medical intervention.
Have active hepatitis B virus (HBV) or hepatitis C virus (HCV), or HIV.
Meet any of the following criteria for cardiac disease: Myocardial infarction or unstable angina pectoris within 6 months of enrollment. History of serious ventricular arrhythmia (ie, ventricular tachycardia or ventricular fibrillation), high-grade atrioventricular block, or other cardiac arrhythmias requiring antiarrhythmic medications (except for atrial fibrillation that is well controlled with antiarrhythmic medication). Mean QT interval corrected for heart rate using the Fridericia's formula (QTcF) ≥ 470 msec. New York Heart Association Class \> III congestive heart failure or known left ventricular ejection fraction \< 40%.
Live vaccines within 28 days of initiation of study drug(s).

What this trial measures

  • Parts A and B: Percentage of Participants with Adverse Events and Serious Adverse EventsFirst dose up to 90 days post last dose (up to approximately 118 weeks)
  • Parts A and B: Percentage of Participants with Laboratory AbnormalitiesFirst 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 EscalationDay 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 EventsFirst dose up to 90 days post last dose (up to approximately 118 weeks)
  • Parts C and D: Percentage of Participants with Laboratory AbnormalitiesFirst dose up to 90 days post last dose (up to approximately 118 weeks)
  • Part C: Percentage of Participants with DLTs During Dose EscalationDay 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.