Actively Recruiting
First-in-human Clinical Study of MTS105 for Advanced Hepatocellular Carcinoma
Led by Shen Lin · Updated on 2024-12-24
14
Participants Needed
1
Research Sites
52 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 studying MTS105, a new mRNA-lipid nanoparticle (LNP) treatment, in adults with advanced hepatocellular carcinoma (HCC), a type of liver cancer. This first-in-human phase 1 trial aims to evaluate the safety and tolerability of intravenous injections of MTS105, which is designed to activate immune T cells to target and destroy liver cancer cells. The study is sponsored by Shen Lin and focuses on patients who have not responded to standard therapies. Participants will receive MTS105 at increasing dose levels starting from 0.05 micrograms per kilogram up to 45 micrograms per kilogram. The treatment delivers mRNA via lipid nanoparticles to the liver, producing a bispecific T-cell engager that targets liver cancer cells specifically. Dose escalation occurs through six levels to assess safety and determine the maximal tolerated dose over the first 28 days after the initial dose. During the study, participants will be closely monitored for adverse events and laboratory changes for four weeks after treatment. Researchers will measure drug levels in the blood, tumor response, progression-free survival, and overall survival over about one year. Assessments include clinical exams, blood tests, imaging scans, and safety evaluations. The trial does not involve a control group or blinding and aims to gather detailed information on MTS105's safety profile and pharmacokinetics in this patient population.
CONDITIONS
Brief 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 carcinoma
- Positive for GPC3 protein expression by immunohistochemical staining
- Failure of standard systemic therapies, including at least one immune checkpoint inhibitor and one targeted therapy
- Presence of measurable tumor lesion according to 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 score of 0 or 1
- Adequate organ and bone marrow function meeting specified laboratory criteria
- Ability to understand and communicate with the investigator and provide informed consent
- Age 18 years or older
You will not qualify if you...
- Active intracranial or brain metastases untreated or treated less than 4 weeks ago
- Immune checkpoint inhibitor treatment within 4 weeks prior to first dose
- Investigational drug use within 4 weeks prior to first dose
- Localized therapies for HCC within 4 weeks prior to first dose
- Other anticancer therapies within 3 weeks prior to first dose
- Non-specific immunomodulatory therapy within 2 weeks prior to first dose
- Herbal or proprietary Chinese medicines for cancer within 1 week prior to first dose
- Prior experimental treatment targeting GPC3 unless still GPC3 positive
- History of liver or hematopoietic stem cell transplantation
- Unresolved toxicity from prior anticancer therapy greater than grade 1
- Major surgery within 28 days prior to first dose
- Uncontrolled hypertension
- Severe heart conditions within 6 months prior to first dose
- QTcF interval above specified limits
- Severe or active infections within specified timeframes
- Incomplete antiviral treatment for hepatitis B or C
- HIV positive status
- Use of systemic corticosteroids or immunosuppressive drugs within 14 days prior to first dose or during study
- History of autoimmune disease requiring systemic treatment within 2 years
- History of other malignancies within 2 years except certain cured cancers
- Pregnancy or breastfeeding
- Any other condition deemed inappropriate by the investigator for study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 weeks
Participants receive escalating doses of MTS105, an mRNA-LNP therapy designed to target and destroy liver cancer cells.
Weekly visits for up to 4 weeks
Duration - Up to 1 year
Participants are monitored for treatment effects including tumor response and survival outcomes.
Periodic visits during the year following treatment
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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