OncoMatch/Clinical Trials/NCT06689540
Mts105 for Advanced Hepatocellular Carcinoma
Is NCT06689540 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies MTS105 for liver cancer, adult.
Treatment: MTS105 — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Hepatocellular Carcinoma
Biomarker criteria
Required: GPC3 positive expression (positive)
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: immune checkpoint inhibitor
Failure of standard systemic therapies, including at least one immune checkpoint inhibitor
Must have received: targeted therapy
Failure of standard systemic therapies, including at least one...targeted therapy (Tyrosine Kinase Inhibitors, and/or anti vascular endothelial growth factor agent)
Cannot have received: immune checkpoint inhibitor
Exception: within 4 weeks (28 days) prior to the first dose
Treatment with any immune checkpoint inhibitor within 4 weeks (28 days) prior to the first dose.
Cannot have received: investigational drug
Exception: within 4 weeks prior to the first dose
Received any investigational drug within 4 weeks prior to the first dose.
Cannot have received: localized therapy for hepatocellular carcinoma (arterial chemoembolization (TACE), arterial infusion chemotherapy (HAIC), Y-90 radioembolization, ablative therapy, stereotactic radiation therapy (SBRT))
Exception: within 4 weeks prior to the first dose
Received localized therapy for hepatocellular carcinoma (HCC), including but not limited to arterial chemoembolization (TACE), arterial infusion chemotherapy (HAIC), Y-90 radioembolization, ablative therapy, or stereotactic radiation therapy (SBRT), within 4 weeks prior to the first dose.
Cannot have received: multi-targeted tyrosine kinase inhibitor
Exception: within 3 weeks
Received other anticancer therapies, such as multi-targeted tyrosine kinase inhibitors (mTKIs) and/or anti-VEGF therapies, within 3 weeks.
Cannot have received: anti-VEGF therapy
Exception: within 3 weeks
Received other anticancer therapies, such as multi-targeted tyrosine kinase inhibitors (mTKIs) and/or anti-VEGF therapies, within 3 weeks.
Cannot have received: non-specific immunomodulatory therapy (interleukin, interferon, thymidine)
Exception: within 2 weeks prior to the first dose
Received non-specific immunomodulatory therapy, including but not limited to interleukin, interferon, thymidine, etc., within 2 weeks prior to the first dose.
Cannot have received: herbal or proprietary Chinese medicine for antitumor indications
Exception: within 1 week prior to the first dose
Received herbal or proprietary Chinese medicine for antitumor indications within 1 week prior to the first dose.
Cannot have received: experimental treatment targeting GPC3
Exception: patients may be enrolled if they remain positive for GPC3 upon testing
Previously received experimental treatment targeting GPC3 (patients may be enrolled if they remain positive for GPC3 upon testing).
Lab requirements
Blood counts
No blood transfusion or colony-stimulating factor therapy within 7 days prior to first dose; ANC ≥ 1.5 × 10^9/L; Lymphocyte count ≥ 0.5 × 10^9/L; Hemoglobin ≥ 90 g/L; Platelet count ≥ 75 × 10^9/L
Kidney function
Serum creatinine ≤ 1.5 × ULN, or endogenous creatinine clearance ≥ 45 mL/min (CKD-EPI); Urinary protein < 2+, or if ≥ 2+ then 24-hour protein ≤ 1.0 g
Liver function
Total bilirubin ≤ 2.5 mg/dL; Albumin ≥ 28 g/L; AST and ALT ≤ 5 × ULN
Cardiac function
LVEF ≥ 50%; No clinically significant abnormal ECG findings (chronic atrial fibrillation allowed if not requiring medication)
Adequate organ and bone marrow function as defined by the following laboratory criteria: ... (see full criteria above)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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