Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of Escalating Doses of SIM0348 as a Single Agent in Advanced Solid Tumors

This is a multicenter, open label, phase I trial to evaluate the safety and tolerability, pharmacokinetic/ pharmacodynamic characteristics and to assess the preliminary efficacy of SIM0348 as monotherapy in adult subjects with advanced and metastatic solid tumors. The trial starts with a dose escalation and dose expansion part (Part 1) followed by a cohort expansion part (Part 2).

Inclusion Criteria:Adults 18 years of age or olderMust have failed at least one established standard anti-cancer therapiesEastern Cooperative Oncology Group (ECOG) performance status of 0 or 1Life expectancy at least 12 weeksAdequate hematologic and end organ functionHistologic 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 careConfirmed availability of representative tumor specimensMeasurable disease according to RECIST Version 1.1Exclusion Criteria:Malignancies other than disease under study within 2 years prior to Day 1 of Cycle 1Primary central nervous system (CNS) malignancy, or untreated/active CNS metastasesHistory 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 investigatorHistory of severe hypersensitivity reactions to chimeric or humanized antibodies or fusion proteinsHistory of autoimmune diseasePositive human immunodeficiency virus (HIV) testSevere infection within 2 weeks prior to the first dose of study treatmentSignificant cardiovascular diseaseHistory of allogeneic tissue/solid organ transplant or graft-versus-host diseaseKnown clinically significant liver disease