Mts105 for Advanced Hepatocellular Carcinoma
MTS105 for HCC
First-in-human Clinical Study of Mts105 for Advanced Hepatocellular Carcinoma
MTS105 for HCC
First-in-human Clinical Study of Mts105 for Advanced Hepatocellular Carcinoma
Sponsor study identifier
interventional
14
1 country
1
Study Start
November 18, 2024
Actual (reported)Primary Completion
December 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 8, 2024
Actual (reported)November 14, 2024
Actual (reported)November 18, 2024
Actual (reported)December 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Incidence of treatment-emergent adverse events (TEAEs), and serious adverse events (SAEs).
Incidence of TEAEs,and SAEs.
From enrollment to the end of treatment at 4 weeks
Maximal Tolerance Dose (MTD)
Determined based on the occurrence of dose-limiting toxicity (DLT).
Within the first 28-days following first dose
Peak Plasma Concentration (Cmax)
Within the first 28-days following first dose
Starting dose, 0.05 ug/kg
dose escalation, 0.5 ug/kg
dose escalation, 3.0 ug/kg
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Peking University Cancer Hospital
Beijing, China
First Submitted
November 8, 2024
First Posted
November 14, 2024
Study Start
November 18, 2024
Actual (reported)Primary Completion
December 31, 2025
Area under the plasma concentration versus time curve (AUC)
Within the first 28-days following first dose
Time for peak concentration (Tmax)
Within the first 28-days following first dose
Elimination half-life
Within the first 28-days following first dose
Steady-state concentration
Within the first 28-days following first dose
Concentration of anti-drug antibodies
through study completion, an average of 1 year
dose escalation, 15.0 ug/kg
dose escalation, 30.0 ug/kg
dose escalation, 45.0 ug/kg
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
December 24, 2024
Record last verified: 2024-10
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: