New cancer drug combo enters first human tests
NCT ID NCT06532565
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage trial is testing a new drug called GS-2121, taken as a tablet, alone or with an intravenous drug called zimberelimab, in 154 adults with advanced solid tumors that have not responded to standard treatments. The main goals are to check safety, find the best dose, and see how the body handles the drug. It is a first-in-human study, so the focus is on safety and dosing, not yet on curing the cancer.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- GS-2121 (tablet) and zimberelimab (intravenous infusion)
- What this could lead to
- If successful, this could point toward a new treatment option for people with advanced solid tumors who have run out of standard therapies.
- What could go wrong
- This is a very early phase 1 trial with only 154 participants, so it is primarily testing safety and dosing. The drug may not shrink tumors or may cause significant side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 154 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2024
- Expected to finish
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Jun 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 Solid Tumors (RECIST) v1.1 criteria. * Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1. * Tissue requirements: 1. Parts A-D: Pre-treatment tumor tissue is required. 2. Parts A and C backfill cohorts: Participants must agree to fresh pre- and on-treatment biopsies. * Adequate organ function. Key Exclusion Criteria: * 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). Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
6 sites in 2 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Beth Israel Deaconess Medical Center
RECRUITINGBoston, Massachusetts, 02215, United States
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NEXT Oncology
RECRUITINGSan Antonio, Texas, 78229, United States
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NEXT Virginia
RECRUITINGFairfax, Virginia, 22031, United States
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Princess Margaret Cancer Centre
RECRUITINGToronto, M5G1Z5, Canada
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Stanford Cancer Center
RECRUITINGPalo Alto, California, 94305, United States
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The Ottawa Hospital Cancer Centre
RECRUITINGOttawa, K1H 8L6, Canada
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- Can a Two-Drug combo outsmart advanced cancer?
- Can an experimental pill boost cancer immunotherapy? early trial puts HG146 to the test
- New injectable drug tested for safety in Hard-to-Treat solid tumors
- New antibody drug conjugate tested against advanced cancers