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).
Any known active intracranial metastases, or brain metastases that have been treated for less than 4 weeks.
Treatment with any immune checkpoint inhibitor within 4 weeks (28 days) prior to the first dose.
Received any investigational drug within 4 weeks prior to the first dose.
Received localized therapy for hepatocellular carcinoma (HCC), including but not limited to arterial chemoembolization (TACE), arterial infusion chemotherapy (HAIC), Y-90 radioembolization, ablative therapy, or stereotactic radiation therapy (SBRT), within 4 weeks prior to the first dose.
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Treatment groupsSee each treatment group below.