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.
Sequential
MTS105
Biological/VaccineMTS105 is a combination of mRNA, which encodes a therapeutic protein, and its delivery vehicle, a lipid nanoparticle (LNP). The starting dose is estimated based on the Minimal Anticipated Biological Effect Level (MABEL) derived from non-clinical studies. A starting dose of 0.05 μg/kg was proposed for this study; following dose strength for escalation are: 0.5 μg/kg, 3.0 μg/kg, 15 μg/kg, 30 μg/kg, 45 μg/kg.
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Treatment groupsSee each treatment group below.
Incidence of treatment-emergent adverse events (TEAEs), and serious adverse events (SAEs).
Incidence of TEAEs,and SAEs.
Maximal Tolerance Dose (MTD)
Determined based on the occurrence of dose-limiting toxicity (DLT).
Peak Plasma Concentration (Cmax)
Peak Plasma Concentration of the investigational product
Area under the plasma concentration versus time curve (AUC)
Time for peak concentration (Tmax)
Time for peak concentration
Elimination half-life
Elimination rate of the therapeutic protein in circulation.
Concentration of anti-drug antibodies
Immunogenicity, anti-drug antibodies
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