First-in-human Clinical Study of Mts105 for Advanced Hepatocellular Carcinoma
This is the first-in-human trial of MTS105 (mRNA-LNP). The goal of this clinical trial is to evaluate the safety, tolerability of intravenous injection of MTS105 in advanced hepatocellular carcinoma.
• Histologically or cytologically confirmed diagnosis of hepatocellular carcinoma (HCC), excluding fibrolamellar or sarcomatoid subtypes, as well as mixed hepato-cholangiocellular carcinoma;
• Positive for GPC3 expression per immunohistochemical (IHC) staining.
• Failure of standard systemic therapies, including at least one immune checkpoint inhibitor and one targeted therapy (Tyrosine Kinase Inhibitors, and/or anti vascular endothelial growth factor agent).
• Presence of a measurable tumor lesion (per RECIST/ mRECIST criteria).
• Barcelona Clinical Liver Cancer Stage B or C (BCLC B/C)
• Child-Pugh Score ≤ 6
• ECOG score ≤ 1
• Adequate organ and bone marrow function as defined by the following laboratory criteria:
∙ Hematology: No blood transfusion or colony-stimulating factor therapy within 7 days prior to the first dose. The following hematological parameters should be met:Absolute neutrophil count ≥ 1.5 × 10\^9/L;Lymphocyte count ≥ 0.5 × 10\^9/L;Hemoglobin ≥ 90 g/L;Platelet count ≥ 75 × 10\^9/L;
‣ Liver function:Total bilirubin ≤ 2.5 mg/dL;Albumin ≥ 28 g/L;Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 5 × ULN;
‣ International Normalized Ratio (INR) ≤ 2.3;Oral anticoagulant therapy at a stable dose for at least 2 weeks. If oral warfarin is used, the patient must have an INR ≤ 3.0 and no bleeding events within 28 days prior to administration;
‣ Renal function:Serum creatinine ≤ 1.5 × ULN, or endogenous creatinine clearance ≥ 45 mL/min (as determined by the CKD-EPI formula);Urinary protein \< 2+, or urinary protein ≥ 2+ but with 24-hour protein quantification ≤ 1.0 g
‣ Cardiac function:Left ventricular ejection fraction (LVEF) ≥ 50%; No clinically significant abnormal ECG findings (chronic atrial fibrillation is allowed, provided it does not require medication);
• Capable of full communication with the investigator, with the ability to understand and comply with study requirements, and able to understand and sign the informed consent form (ICF).
⁃ ≥18 years