An Open-label, Phase I Trial of SIM1811-03 to Assess the Safety, Efficacy and Pharmacokinetics/Pharmacodynamics in Subjects With Advanced Tumors
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.
• Written informed consent must be obtained prior to any procedures that are not considered standard of care.
• ≥18 years old on the day of signing informed consent, male or female;
• Histologically and/or cytologically documented advanced/metastatic solid tumors or histologically confirmed CTCL;
• Have relapsed or refractory advanced solid tumors or CTCL, whose disease has progressed during or after standard therapy
• At least one measurable tumor lesion (RECIST 1.1) for participants with solid tumors. Tumor lesions previously treated with radiotherapy or local therapy should not be considered as measurable unless progression is documented.
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
• Life expectancy of ≥ 12 weeks.
• Adequate organ and marrow functions 9） Provide archived or fresh biopsy tumor tissue samples or tissue sections
⁃ 10\) Females of childbearing potential require strict contraception during the study.