Trials / Recruiting
RecruitingNCT06689540
Mts105 for Advanced Hepatocellular Carcinoma
First-in-human Clinical Study of Mts105 for Advanced Hepatocellular Carcinoma
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 14 (estimated)
- Sponsor
- Shen Lin · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
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.
Conditions
- Liver Cancer, Adult
- Metastatic Liver Cancers
- HCC - Hepatocellular Carcinoma
- Hepatocellular Carcinoma (HCC)
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | MTS105 | 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. |
Timeline
- Start date
- 2024-11-18
- Primary completion
- 2025-12-31
- Completion
- 2026-12-31
- First posted
- 2024-11-14
- Last updated
- 2024-12-24
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06689540. Inclusion in this directory is not an endorsement.