Trial Parameters
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Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Histologically or cytologically confirmed diagnosis of hepatocellular carcinoma (HCC), excluding fibrolamellar or sarcomatoid subtypes, as well as mixed hepato-cholangiocellular carcinoma; 2. Positive for GPC3 expression per immunohistochemical (IHC) staining. 3. 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). 4. Presence of a measurable tumor lesion (per RECIST/ mRECIST criteria). 5. Barcelona Clinical Liver Cancer Stage B or C (BCLC B/C) 6. Child-Pugh Score ≤ 6 7. ECOG score ≤ 1 8. Adequate organ and bone marrow function as defined by the following laboratory criteria: 1. 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;Hemoglo