Advanced Solid TumorsPhase 1NCT06532565
Study of GS-2121 Given Alone or in Combination in Adults With Advanced Solid Tumors
A Phase 1 study testing GS-2121 and Zimberelimab in people with Advanced Solid Tumors, run by Gilead Sciences at 6 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- GS-2121 and Zimberelimab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 26 Jul 2024to Jun 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- Parts A-D: Pre-treatment tumor tissue is required.
- Parts A and C backfill cohorts: Participants must agree to fresh pre- and on-treatment biopsies.
- Adequate organ function.
Who cannot join
- 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).
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- 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).
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
6 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Gilead Clinical Study Information Center contact
6 sites in 2 countries
United States4 sites, 4 recruiting
- Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
- Recruiting
NEXT Virginia
Fairfax, Virginia, 22031
- Recruiting
Stanford Cancer Center
Palo Alto, California, 94305
- Recruiting
NEXT Oncology
San Antonio, Texas, 78229
Canada2 sites, 2 recruiting
- Recruiting
The Ottawa Hospital Cancer Centre
Ottawa, K1H 8L6
- Recruiting
Princess Margaret Cancer Centre
Toronto, M5G1Z5
About this study
Official title: A Phase 1 Study to Evaluate the Safety and Tolerability of GS-2121 as Monotherapy and in Combination in Adults With Advanced Solid Tumors
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.
- Conditions
- Advanced Solid Tumors
- Being tested
- GS-2121, Zimberelimab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GS-2121Drug
Tablet administered orally
ZimberelimabDrug
Also called GS-0122, AB122
Administered intravenously
| Study group | Role | What they receive |
|---|---|---|
| Part A: GS-2121 Monotherapy Dose Escalation | Experimental | Participants 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. Receives: Drug: GS-2121 |
| Part B: GS-2121 Monotherapy Dose Expansion | Experimental | Participants with selected indications will receive GS-2121 monotherapy at the recommended dose for expansion. Receives: Drug: GS-2121 |
| Part C: Combination Dose Escalation of GS-2121 with Zimberelimab | Experimental | Participants 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. Receives: Drug: GS-2121; Drug: Zimberelimab |
| Part D: Combination Dose Expansion of GS-2121 with Zimberelimab | Experimental | Participants with selected indications will receive GS-2121 at the recommended dose for expansion in combination with zimberelimab. Receives: Drug: GS-2121; Drug: Zimberelimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parts A and B: Percentage of Participants with Adverse Events and Serious Adverse Events
Measured: 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: 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
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.
Measured: Day 1 up to Day 21
Parts C and D: Percentage of Participants with Adverse Events and Serious Adverse Events
Measured: First dose up to 90 days post last dose (up to approximately 118 weeks)
Parts C and D: Percentage of Participants with Laboratory Abnormalities
Measured: First dose up to 90 days post last dose (up to approximately 118 weeks)
Part C: Percentage of Participants with DLTs During Dose Escalation
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.
Measured: Day 1 up to Day 21
Secondary outcomes (8)
Parts A and B: Plasma Concentration of GS-2121 and Active Metabolite
Measured: Predose and postdose up to end of treatment (up to 105 weeks)
Parts A and B: PK Parameter: AUC0-24 of GS-2121
AUC0-24 is defined as the partial area under the concentration of drug over time between time 0 and time 24 hours. PK parameters will be estimated as applicable, based on the availability of data.
Measured: Predose and postdose up to end of treatment (up to 105 weeks)
Parts A and B: PK Parameter: Cmax of GS-2121
Cmax is defined as the maximum observed drug concentration. PK parameters will be estimated as applicable, based on the availability of data.
Measured: Predose and postdose up to end of treatment (up to 105 weeks)
Parts A and B: PK Parameter: Tmax of GS-2121
Tmax is defined as the time to maximum observed drug concentration. PK parameters will be estimated as applicable, based on the availability of data.
Measured: Predose and postdose up to end of treatment (up to 105 weeks)
Parts C and D: Plasma Concentration of GS-2121 and Active Metabolite
Measured: Predose and postdose up to end of treatment (up to 105 weeks)
Parts C and D: PK Parameter: AUC0-24 of GS-2121
AUC0-24 is defined as the partial area under the concentration of drug over time between time 0 and time 24 hours. PK parameters will be estimated as applicable, based on the availability of data.
Measured: Predose and postdose up to end of treatment (up to 105 weeks)
Parts C and D: PK Parameter: Cmax of GS-2121
Cmax is defined as the maximum observed drug concentration. PK parameters will be estimated as applicable, based on the availability of data.
Measured: Predose and postdose up to end of treatment (up to 105 weeks)
Parts C and D: PK Parameter: Tmax of GS-2121
Tmax is defined as the time to maximum observed drug concentration. PK parameters will be estimated as applicable, based on the availability of data.
Measured: Predose and postdose up to end of treatment (up to 105 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2024
- Study start26 Jul 2024
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 154 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gilead Study Director, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06532565
- Sponsor's protocol ID
- GS-US-579-6764
- Other IDs
- 2024-511739-81
- Status last verified
- Apr 2026
- First submitted
- 29 Jul 2024
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Evaluate the Safety and Tolerability of GS-2121 as Monotherapy and in Combination in Adults With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06532565
- Acronym / sponsor ID
- GS-US-579-6764
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 154 participants (estimated)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- 26 Jul 2024 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 1 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part A: GS-2121 Monotherapy Dose Escalation | Experimental | Drug: GS-2121Participants 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 Expansion | Experimental | Drug: GS-2121Participants with selected indications will receive GS-2121 monotherapy at the recommended dose for expansion. |
| Part C: Combination Dose Escalation of GS-2121 with Zimberelimab | Experimental | Drug: GS-2121, Drug: ZimberelimabParticipants 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 Zimberelimab | Experimental | Drug: GS-2121, Drug: ZimberelimabParticipants with selected indications will receive GS-2121 at the recommended dose for expansion in combination with zimberelimab. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GS-2121Tablet administered orally | Drug | Part A: GS-2121 Monotherapy Dose Escalation, Part B: GS-2121 Monotherapy Dose Expansion, Part C: Combination Dose Escalation of GS-2121 with Zimberelimab, Part D: Combination Dose Expansion of GS-2121 with Zimberelimab |
| ZimberelimabAlso: GS-0122, AB122Administered intravenously | Drug | Part C: Combination Dose Escalation of GS-2121 with Zimberelimab, Part D: Combination Dose Expansion of GS-2121 with Zimberelimab |
Primary outcome
Parts A and B: Percentage of Participants with Adverse Events and Serious Adverse Events
Time frame: First dose up to 90 days post last dose (up to approximately 118 weeks)
Parts A and B: Percentage of Participants with Laboratory Abnormalities
Time frame: 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
Time frame: 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
Time frame: First dose up to 90 days post last dose (up to approximately 118 weeks)
Parts C and D: Percentage of Participants with Laboratory Abnormalities
Time frame: First dose up to 90 days post last dose (up to approximately 118 weeks)
Part C: Percentage of Participants with DLTs During Dose Escalation
Time frame: 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.
8 secondary outcomes
Parts A and B: Plasma Concentration of GS-2121 and Active Metabolite
Time frame: Predose and postdose up to end of treatment (up to 105 weeks)
Parts A and B: PK Parameter: AUC0-24 of GS-2121
Time frame: Predose and postdose up to end of treatment (up to 105 weeks)
Parts A and B: PK Parameter: Cmax of GS-2121
Time frame: Predose and postdose up to end of treatment (up to 105 weeks)
Parts A and B: PK Parameter: Tmax of GS-2121
Time frame: Predose and postdose up to end of treatment (up to 105 weeks)
Parts C and D: Plasma Concentration of GS-2121 and Active Metabolite
Time frame: Predose and postdose up to end of treatment (up to 105 weeks)
Parts C and D: PK Parameter: AUC0-24 of GS-2121
Time frame: Predose and postdose up to end of treatment (up to 105 weeks)
Parts C and D: PK Parameter: Cmax of GS-2121
Time frame: Predose and postdose up to end of treatment (up to 105 weeks)
Parts C and D: PK Parameter: Tmax of GS-2121
Time frame: Predose and postdose up to end of treatment (up to 105 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Gilead Clinical Trials WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gilead Clinical Study Information Center contact
Gilead Study Director study director
Gilead Sciences
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GS-2121 and Zimberelimab in people with Advanced Solid Tumors, run by Gilead Sciences at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gilead Clinical Study Information Center (1-833-445-3230 (GILEAD-0), GileadClinicalTrials@gilead.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parts A and B: Percentage of Participants with Adverse Events and Serious Adverse Events (time frame: First dose up to 90 days post last dose (up to approximately 118 weeks)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.