Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0348 in Advanced Solid Tumors

Inclusion Criteria: * Adults 18 years of age or older * Must have failed at least one established standard anti-cancer therapies * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Life expectancy at least 12 weeks * Adequate hematologic and end organ function * Histologic documentation of locally advanced, recurrent, or metastatic incurable malignancy that has progressed after at least one available standard therapy; or for which standard therapy has proven ineffective, intolerable, or considered inappropriate; or for which a clinical trial of an investigational agent is a recognized standard of care * Confirmed availability of representative tumor specimens * Measurable disease according to RECIST Version 1.1 Exclusion Criteria: * Malignancies other than disease under study within 2 years prior to Day 1 of Cycle 1 * Primary central nervous system (CNS) malignancy, or untreated/active CNS metastases * History of interstitial lung disease, evidence of active pneumonitis (history of radiation pneumonitis in the radiation field \[fibrosis\] is permitted), and active pneumonia that are considered inappropriate by the investigator * History of severe hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins * History of autoimmune disease * Positive human immunodeficiency virus (HIV) test * Severe infection within 2 weeks prior to the first dose of study treatment * Significant cardiovascular disease * History of allogeneic tissue/solid organ transplant or graft-versus-host disease * Known clinically significant liver disease