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Phase 1Recruiting
View on ClinicalTrials.gov

Comparing 4 approaches for advanced solid tumors

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

A Phase 1 Study to Evaluate the Safety and Tolerability of GS-2121 as Monotherapy and in Combination in Adults With Advanced Solid Tumors

Condition: Advanced Solid TumorsSponsor: Gilead SciencesTarget enrollment: 154
  • Phase 1
  • 4 groups
  • Sites in Ottawa and Toronto
  • Recruiting
The Ottawa Hospital Cancer Centre, OttawaPrincess Margaret Cancer Centre, Toronto

Interventions

  • Medication

    GS-2121

    Tablet administered orally

  • Medication

    Zimberelimab

    Administered intravenously

Canadian Sites (2)

2 of 2 recruiting

  • The Ottawa Hospital Cancer Centre

    Ottawa

    Recruiting
  • Princess Margaret Cancer Centre

    Toronto

    Recruiting

Eligibility Criteria

See who this study is looking for23 criteria

The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.

Inclusion

  • +Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1.
  • +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.
  • +Tissue requirements:
  • +Parts A-D: Pre-treatment tumor tissue is required.
  • +Parts A and C backfill cohortsCohortA group of participants sharing a characteristic, followed together.Read more →: Participants must agree to fresh pre- and on-treatment biopsies.
  • +Adequate organ function.

Exclusion

  • Have known active central nervous system (CNS) metastases and/or leptomeningeal disease (LMD).
  • Have active hepatitis B virus (HBV) or hepatitis C virus (HCV), or HIV.
  • Requirement for ongoing therapy with any prohibited medications.
  • Any prior allogeneic tissue/solid organ transplantation, including allogeneic stem cell transplantation.
  • Have not recovered (ie, returned to Grade 1 or baselineBaselineYour starting measurements, taken before treatment begins.Read more →) from AEs due to a previously administered agent.
  • 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.
  • Ascites or pleural effusion that is symptomatic and/or requiring medical intervention.
  • Meet any of the following criteria for cardiac disease: Myocardial infarction or unstable angina pectoris within 6 months of enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more →. 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).
  • Note: Other protocolProtocolThe detailed plan a study must follow.Read more → defined InclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more →/Exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → may apply.
  • Positive serum pregnancy test or participant who is breastfeeding.
  • 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).
  • History of pneumonitis requiring treatment with corticosteroids, interstitial lung disease, or severe radiation pneumonitis (excluding localized radiation pneumonitis).
5 concepts to explore on this page · up to 1,300 pointsTap any term to learn what it means.

In plain language

Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.

Learning 
What this study is

This study is testing a treatment for a condition.

Phase 1Phase 1The earliest stage of human testing, in a small group, focused on safety.Read more → — an early safety study in a small group, checking how it is tolerated and at what dose.

From the trial registry

Built from these fields:

  • designModule.designInfo.primaryPurpose
  • designModule.phases
Who receives what

There are 4 groups in this study.

Groups A and B receive GS-2121.

Registry label: A: Part A: GS-2121 Monotherapy Dose Escalation · B: Part B: GS-2121 Monotherapy Dose Expansion

Groups C and D receive GS-2121 and Zimberelimab.

Registry label: C: Part C: Combination Dose Escalation of GS-2121 with Zimberelimab · D: Part D: Combination Dose Expansion of GS-2121 with Zimberelimab

From the trial registry

Built from these fields:

  • armsInterventionsModule.armGroups[].label
  • armsInterventionsModule.armGroups[].type
  • armsInterventionsModule.armGroups[].interventionNames
How the study is run

Groups are assigned by the study team using set rules, rather than by chance.

This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.

From the trial registry

Built from these fields:

  • designModule.designInfo.allocation
  • designModule.designInfo.maskingInfo.masking
Is there a placebo?

This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.

From the trial registry

Built from these fields:

  • armsInterventionsModule.armGroups[].type
  • armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for

The study lists a minimum age of 18 years, with no upper limit given.

The study is open to people of any sex.

The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.

These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.

From the trial registry

Built from these fields:

  • eligibilityModule.minimumAge
  • eligibilityModule.sex
  • eligibilityModule.healthyVolunteers
How big and how long

The study aims to enrol about 154 people.

The study is currently expected to finish around June 2028.

The main measurement is taken over: First dose up to 90 days post last dose (up to approximately 118 weeks).

From the trial registry

Built from these fields:

  • designModule.enrollmentInfo.count
  • statusModule.completionDateStruct.date
  • outcomesModule.primaryOutcomes[].timeFrame
What the study measures

Parts A and B: Percentage of Participants with Adverse EventsAdverse eventAny medical problem that happens during a study, whether or not the treatment caused it.Read more → and Serious Adverse EventsSerious adverse eventAn adverse event meeting a formal severity threshold, such as requiring hospital admission.Read more → — measured over First dose up to 90 days post last dose (up to approximately 118 weeks).

Parts A and B: Percentage of Participants with Laboratory Abnormalities — measured over 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 EscalationDose escalationLater groups receive higher amounts than earlier ones, increased step by step.Read more → — measured over Day 1 up to Day 21.

Parts C and D: 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).

The study lists 2 further main measurements.

From the trial registry

Built from these fields:

  • outcomesModule.primaryOutcomes[].measure
  • outcomesModule.primaryOutcomes[].timeFrame

Source: NCT06532565 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.

Not medical advice. What do these terms mean?

What is being tested — in plain terms

About GS-2121Drug

Tablet administered orally

From the trial registry — its own words, unedited.

What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.

Read the full explanation → · in clinical review

About ZimberelimabDrug

Administered intravenously

From the trial registry — its own words, unedited.

What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.

Read the full explanation → · in clinical review

Common questions

Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.

Am I eligible for this trial?

Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.

What the study lists: a minimum age of 18 years.

The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.

The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.

From the trial registry
  • eligibilityModule.minimumAge
  • eligibilityModule.eligibilityCriteria
Is there a placebo?

This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.

From the trial registry
  • armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?

This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.

Groups are assigned by the study team using set rules, rather than by chance.

From the trial registry
  • designModule.designInfo.maskingInfo.masking
  • designModule.designInfo.allocation
Who can join?

The study lists a minimum age of 18 years, with no upper limit given.

It is open to people of any sex.

It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.

Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.

From the trial registry
  • eligibilityModule.minimumAge
  • eligibilityModule.sex
  • eligibilityModule.healthyVolunteers
How long would this take?

The study's main measurement is taken over: First dose up to 90 days post last dose (up to approximately 118 weeks).

The study as a whole is currently expected to finish around 2028-06.

How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.

From the trial registry
  • outcomesModule.primaryOutcomes[].timeFrame
  • statusModule.completionDateStruct.date
How many people are taking part?

The study aims to enrol about 154 people.

From the trial registry
  • designModule.enrollmentInfo.count
Where is this happening?

This study lists 2 locations, including: Ottawa, Canada; Toronto, Canada.

Sites can open and close during a study, so confirm with the team before travelling.

From the trial registry
  • trial_locations

About This Trial

The main goal of this first-in-human (FIH) study is to learn about the safety and dosing of GS-2121 when given alone or in combination with zimberelimab (ZIM) in participants with advanced solid tumors. The primary objectives of this study are: * To assess the safety and tolerability of GS-2121 as monotherapy and GS-2121 in combination with zimberelimab in participants with advanced solid tumors. * To identify the maximum tolerated dose (MTD) / maximum administered dose (MAD) and/or the recommended phase 2 dose (RP2D) of GS-2121 as monotherapy and in combination with zimberelimab in participants with advanced solid tumors.

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This page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.