Phase
Condition
Neoplasms
Treatment
GS-2121
Zimberelimab
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
Participants diagnosed with histologically or cytologically confirmed advanced solidtumors who have progressed despite standard therapy, are intolerant to standardtherapy, or are ineligible for standard therapy.
Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1criteria.
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- andon-treatment biopsies.
- Adequate organ function.
Exclusion
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 protocolspecified time prior to initiation of study including: major surgery (<4 weeks),experimental therapy (<21 days or <5 half-lives whichever is longer), approvedimmunotherapy or biologic therapy (<28 days), approved chemotherapy (<21 days or <42days for mitomycin or nitrosoureas), approved targeted small molecule therapy (<14days or <5 half-lives whichever is longer), hormonal therapy or other adjunctivetherapy for cancers other than cancer under evaluation in this study (<14 days) orradiation therapy (<21 days).
Any prior allogeneic tissue/solid organ transplantation, including allogeneic stemcell transplantation.
Have not recovered (ie, returned to Grade 1 or baseline) from AEs due to apreviously administered agent.
Have known active central nervous system (CNS) metastases and/or leptomeningealdisease (LMD).
Diagnosis of immunodeficiency, either primary or acquired.
History of autoimmune disease or active autoimmune disease that has requiredsystemic 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 notcontrolled or requires systemic antibiotics, antifungals, or antivirals,respectively.
History of pneumonitis requiring treatment with corticosteroids, interstitial lungdisease, or severe radiation pneumonitis (excluding localized radiationpneumonitis).
Ascites or pleural effusion that is symptomatic and/or requiring medicalintervention.
Have active hepatitis B virus (HBV) or hepatitis C virus (HCV), or HIV.
Meet any of the following criteria for cardiac disease: Myocardial infarction orunstable angina pectoris within 6 months of enrollment. History of seriousventricular arrhythmia (ie, ventricular tachycardia or ventricular fibrillation),high-grade atrioventricular block, or other cardiac arrhythmias requiringantiarrhythmic medications (except for atrial fibrillation that is well controlledwith antiarrhythmic medication). Mean QT interval corrected for heart rate using theFridericia's formula (QTcF) ≥ 470 msec. New York Heart Association Class > IIIcongestive 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.
Study Design
Connect with a study center
The Ottawa Hospital Cancer Centre
Ottawa, K1H 8L6
CanadaActive - Recruiting
Princess Margaret Cancer Centre
Toronto, M5G1Z5
CanadaActive - Recruiting
Stanford Cancer Center
Palo Alto, California 94305
United StatesActive - Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215
United StatesActive - Recruiting
NEXT Oncology
San Antonio, Texas 78229
United StatesActive - Recruiting
NEXT Virginia
Fairfax, Virginia 22031
United StatesActive - Recruiting
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