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.
MTS105 is an mRNA-LNP combination. Once the mRNA is delivered to the liver via lipid nanoparticles (LNP), it translates into a therapeutic bispecific T-cell engager designed to activate T cells to target and destroy liver cancer cells. MTS105 is anticipated to offer liver-targeted delivery, specific binding to hepatocellular carcinoma cells, a broad therapeutic window, and potent anti-tumor effects.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
14
MTS105 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.
Peking University Cancer Hospital
Beijing, China
RECRUITINGIncidence of treatment-emergent adverse events (TEAEs), and serious adverse events (SAEs).
Incidence of TEAEs,and SAEs.
Time frame: From enrollment to the end of treatment at 4 weeks
Maximal Tolerance Dose (MTD)
Determined based on the occurrence of dose-limiting toxicity (DLT).
Time frame: Within the first 28-days following first dose
Peak Plasma Concentration (Cmax)
Peak Plasma Concentration of the investigational product
Time frame: Within the first 28-days following first dose
Area under the plasma concentration versus time curve (AUC)
Time frame: Within the first 28-days following first dose
Time for peak concentration (Tmax)
Time for peak concentration
Time frame: Within the first 28-days following first dose
Elimination half-life
Elimination rate of the therapeutic protein in circulation.
Time frame: Within the first 28-days following first dose
Steady-state concentration
steady-state concentration
Time frame: Within the first 28-days following first dose
Objective Response Rate
The proportion of participants who have a confirmed CR or confirmed PR as determined by the investigator at local site per RECIST v1.1 or mRECIST 1.1
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Time frame: through study completion, an average of 1 year
Duration of Response (DOR)
The time from first documented confirmed response until date of documented progression of disease, as determined by investigator at local site or death due to any cause.
Time frame: through study completion, an average of 1 year
Progression Free Survival (PFS)
Time from infusion date until progression, as assessed by the investigator at local site, or death due to any cause.
Time frame: through study completion, an average of 1 year
Overall Survival (OS)
Overall Survival (OS)
Time frame: through study completion, an average of 1 year