Status:
RECRUITING
Study of GS-2121 Given Alone or in Combination in Adults With Advanced Solid Tumors
Lead Sponsor:
Gilead Sciences
Conditions:
Advanced Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 tumor...
Eligibility Criteria
Inclusion
- Key
- 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: Pretreatment tumor tissue is required.
- Parts A and C backfill cohorts: Participants must agree to fresh pre- and on-treatment biopsies.
- Adequate organ function.
- Key
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 longer), 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.
Key Trial Info
Start Date :
July 26 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2028
Estimated Enrollment :
154 Patients enrolled
Trial Details
Trial ID
NCT06532565
Start Date
July 26 2024
End Date
June 1 2028
Last Update
May 16 2025
Active Locations (6)
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1
Stanford Cancer Center
Palo Alto, California, United States, 94305
2
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
3
NEXT Oncology
San Antonio, Texas, United States, 78229
4
NEXT Virginia
Fairfax, Virginia, United States, 22031