This is a phase I trial to evaluate the safety, efficacy, and pharmacokinetic/ pharmacodynamic characteristics of SIM1811-03 in subjects with advanced tumors.~The trial is composed of two parts, Part I and Part II. Part I is a dose escalation part to determine the MTD and/or RD of SIM1811-03. Approximately70 subjects will be enrolled in this part. Part II is a dose expansion part at RD level SIM1811-03 determined in Part I to assess the anti-tumor activity of SIM1811-03 in subjects with advanced solid tumors or CTCL. The tumor types in Part II will be adjusted based on the response observed in Part I. Approximately 50 subjects will be enrolled in this part.~Part I: Dose escalation part (5 Dose Levels planned for Q2W dosing and 2 Dose Levels planned for Q3W dosing.)~Part II:~Cohort 1: Patients with CTCL (approximately 20 subjects) Cohort 2: Patients with advanced/metastatic solid tumors, including ovarian cancer, NSCLC, and hepatocellular carcinoma etc. (approximately 30 subjects)
This is a first in human, open-label, dose escalation and expansion Phase I study of SIM1811-03 in adult patients with advanced tumors. SIM1811-03 is a first-in-class IgG1-based humanized anti-tumor necrosis factor type 2 receptor (TNFR2) monoclonal antibody for the treatment of malignant tumors.