Actively Recruiting
Mts105 for Advanced Hepatocellular Carcinoma
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
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.
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
AI-Screening
AI-Powered Screening
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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
CONTACT
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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