Study of GS-4528 in Adults With Solid Tumors

Exclusion Criteria

• •Positive serum pregnancy test or lactating female.
• •Prohibited concurrent anticancer therapy listed in the protocol.
• •Any anti-cancer therapy, whether investigational or approved, within protocol specified time prior to initiation of study including: major surgery (\<28 days), immunotherapy or biologic therapy (\< 28 days), chemotherapy (\< 21 days), targeted small molecule therapy (\< 14 days or \< 5 half-lives whichever is shorter), hormonal therapy or other adjunctive therapy (\< 14 days) or radiotherapy (\< 21 days).
• •Any prior allogeneic tissue/solid organ transplantation, including allogeneic stem cell transplantation.
• •Diagnosis of immunodeficiency, either primary or acquired, or systemic steroid requirement of \> 10 mg of prednisone or equivalent.
• •History of intolerance, hypersensitivity, or treatment discontinuation due to severe immune-related adverse events (irAEs) on prior immunotherapy.
• •History of autoimmune disease or active autoimmune disease that has required systemic treatment within 2 years prior to the start of study treatment.
• •Concurrent active second malignancy. Note: Individuals with a history of malignancy that have been completely treated, with no evidence of active cancer for 2 years prior to enrollment, or participants with surgically cured tumors with low risk of recurrence are allowed to enroll.
• •Have known active central nervous system (CNS) metastases and/ or carcinomatous meningitis.
• •Significant cardiovascular disease.
• •Have active serious infection requiring antibiotics.
• •Have active hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV).
• •History of pneumonitis, interstitial lung disease, or severe radiation pneumonitis (excluding localized radiation pneumonitis).
• •Symptomatic ascites or pleural effusion.
• •Live vaccines within 28 days of initiation of investigational product(s).