Actively Recruiting
First-in-human Study of MTS105 mRNA-LNP Injection for Advanced Hepatocellular Carcinoma Evaluating Safety and Dose Levels of MTS105 in Liver Cancer Patients
Led by Shen Lin · Updated on 2024-12-24
14
Participants Needed
1
Research Sites
110 weeks
Total Duration
On this page
Sponsors
S
Shen Lin
Lead Sponsor
M
METiS Pharmaceuticals
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating MTS105, a new mRNA-LNP therapy, for safety and tolerability in adults with advanced hepatocellular carcinoma, a type of liver cancer. This first-in-human Phase 1 trial focuses on patients with specific liver cancer characteristics, including positive GPC3 expression and prior failure of standard treatments. MTS105 aims to activate T cells to specifically target and destroy liver cancer cells, offering a potentially targeted anti-tumor approach. MTS105 is administered through intravenous injection beginning at a low dose of 0.05 bcg/kg, with planned dose escalations up to 45 bcg/kg. The treatment is delivered via lipid nanoparticles designed to carry the mRNA directly to the liver. The study monitors safety and dose tolerance over a treatment period lasting 4 weeks, with dose escalation based on biological effect levels from earlier non-clinical studies. Participants will undergo regular assessments including laboratory tests for hematology, liver, kidney, and cardiac function, along with tumor measurements by imaging criteria. The trial tracks adverse events and determines the maximal tolerated dose within the first 28 days of treatment. The study requires participants to communicate fully with investigators and comply with study procedures, including signing informed consent. Safety monitoring continues through the treatment period to evaluate potential side effects and treatment impact.
CONDITIONS
Official Title
Mts105 for Advanced Hepatocellular Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed hepatocellular carcinoma (HCC), excluding fibrolamellar, sarcomatoid, and mixed hepato-cholangiocellular subtypes
- Positive for GPC3 expression by immunohistochemical staining
- Failure of standard systemic therapies including at least one immune checkpoint inhibitor and one targeted therapy
- Presence of a measurable tumor lesion by RECIST or mRECIST criteria
- Barcelona Clinical Liver Cancer Stage B or C (BCLC B/C)
- Child-Pugh Score of 6 or less
- ECOG performance status of 0 or 1
- Adequate organ and bone marrow function as defined by specific hematology, liver, renal, and cardiac lab criteria
- Ability to communicate fully with investigators and comply with study requirements
- Age 18 years or older
You will not qualify if you...
- Active intracranial or brain metastases treated less than 4 weeks ago
- Recent treatments: immune checkpoint inhibitors (within 4 weeks), investigational drugs (within 4 weeks), localized HCC therapies (within 4 weeks), other anticancer therapies (within 3 weeks), non-specific immunomodulatory therapy (within 2 weeks), herbal antitumor medicines (within 1 week)
- Prior experimental treatment targeting GPC3 unless still GPC3 positive
- History of liver or hematopoietic stem cell transplantation
- Unresolved toxicity greater than grade 1 from prior anticancer therapy
- Major surgery (other than biopsy) within 28 days
- Uncontrolled hypertension (systolic 260 mmHg or diastolic 290 mmHg)
- Severe heart conditions within 6 months including heart failure NYHA class III-IV, unstable angina, recent myocardial infarction, bypass surgery, stents, cerebral infarction, or significant valvular disease
- QTcF interval 2450 ms in men or 2470 ms in women
- Severe infection or fever above 38.5DAC within specified recent timeframes
- For HBV-associated HCC, insufficient antiviral treatment or high HBV DNA viral load
- Hepatitis C infection without 4 weeks of antiviral treatment
- HIV positive
- Use of systemic corticosteroids or immunosuppressives within 14 days before or during study
- History of autoimmune disease requiring systemic treatment within 2 years
- History of other malignancies within 2 years except certain cured cancers
- Pregnant or breastfeeding women
- Any condition making participation inappropriate per investigator judgment
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Trial Site Locations
Total: 1 location
1
Peking University Cancer Hospital
Beijing, China
Actively Recruiting
Research Team
L
Lin Professor, M.D
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
6
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