Single Arm Clinical Study Protocol of GV20-0251 in the Treatment of Advanced/Refractory Solid Tumors
This is a single-arm, single-center study for multiple tumor indications to evaluate the safety of GV20-0251. The trial uses a 3 + 3 design and enrolls 3-6 patients in the 10 mg/kg and 20 mg/kg dose groups, respectively. The cancer types include solid tumors.
• Before conducting any study-specific procedures, voluntarily sign an informed consent form.
• Be able and willing to participate throughout the entire study period and comply with study procedures.
• participants ≥18 years of age
• Previously treated, histologically-confirmed advanced solid malignancy with progressive disease requiring therapy (Refractory or intolerant to standard therapies, must have received the standard of care therapy)
• ECOG performance status of 0 or 1 before C1D1
• Disease-free of active second/secondary or prior malignancies for ≥ 2 years Laboratory test results within the required parameters
• Women of childbearing potential (WOCBP) and men must agree to use adequate contraception