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A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GS-5745 as Monotherapy and in Combination With Chemotherapy in Subjects With Advanced Solid Tumors

Primary: To determine the maximum tolerated dose (MTD) of GS-5745 Monotherapy in subjects with advanced solid tumors. To characterize the safety and tolerability of GS-5745 as Monotherapy and in combination with various chemotherapy regimens in subjects with select tumor types. Secondary: To characterize the PK of GS-5745. To evaluate the formation of anti-GS-5745 antibodies. To evaluate exploratory pharmacodynamics biomarkers related to GS-5745 mechanism of action. To evaluate exploratory biomarkers associated with disease prognosis and/or benefit from drug Exploratory: To summarize investigator-assessed objective response rate (ORR), progression-free survival (PFS), and overall survival (OS) for subjects enrolled in Part B by tumor type using descriptive characteristics.



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Past Studies