RecruitingPhase 1NCT06689540

Mts105 for Advanced Hepatocellular Carcinoma

First-in-human Clinical Study of Mts105 for Advanced Hepatocellular Carcinoma


Sponsor

Shen Lin

Enrollment

14 participants

Start Date

Nov 18, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new treatment called Mts105 for people with advanced liver cancer (hepatocellular carcinoma, or HCC) whose cancer has stopped responding to standard therapies. Mts105 is a targeted treatment designed to attack cancer cells that carry a protein called GPC3. **You may be eligible if...** - You have confirmed advanced liver cancer (HCC), not including uncommon subtypes - Your cancer cells test positive for the GPC3 protein - Your cancer has progressed after trying at least one immune checkpoint inhibitor and one targeted therapy (such as a tyrosine kinase inhibitor) - You are 18 or older and in reasonable general health **You may NOT be eligible if...** - Your cancer is a rare subtype (such as fibrolamellar or sarcomatoid HCC) - You have not yet tried standard systemic treatments - You have serious liver disease, major infections, or other significant health conditions - Your cancer has spread to the brain Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALMTS105

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.


Locations(1)

Peking University Cancer Hospital

Beijing, China

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NCT06689540


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