First-in-human Clinical Study of Mts105 for Advanced Hepatocellular Carcinoma

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Histologically or cytologically confirmed diagnosis of hepatocellular carcinoma (HCC), excluding fibrolamellar or sarcomatoid subtypes, as well as mixed hepato-cholangiocellular carcinoma;

• Positive for GPC3 expression per immunohistochemical (IHC) staining.

• Failure of standard systemic therapies, including at least one immune checkpoint inhibitor and one targeted therapy (Tyrosine Kinase Inhibitors, and/or anti vascular endothelial growth factor agent).

• Presence of a measurable tumor lesion (per RECIST/ mRECIST criteria).

• Barcelona Clinical Liver Cancer Stage B or C (BCLC B/C)

• Child-Pugh Score ≤ 6

• ECOG score ≤ 1

• Adequate organ and bone marrow function as defined by the following laboratory criteria:

∙ Hematology: No blood transfusion or colony-stimulating factor therapy within 7 days prior to the first dose. The following hematological parameters should be met:Absolute neutrophil count ≥ 1.5 × 10\^9/L;Lymphocyte count ≥ 0.5 × 10\^9/L;Hemoglobin ≥ 90 g/L;Platelet count ≥ 75 × 10\^9/L;

‣ Liver function:Total bilirubin ≤ 2.5 mg/dL;Albumin ≥ 28 g/L;Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 5 × ULN;

‣ International Normalized Ratio (INR) ≤ 2.3;Oral anticoagulant therapy at a stable dose for at least 2 weeks. If oral warfarin is used, the patient must have an INR ≤ 3.0 and no bleeding events within 28 days prior to administration;

‣ Renal function:Serum creatinine ≤ 1.5 × ULN, or endogenous creatinine clearance ≥ 45 mL/min (as determined by the CKD-EPI formula);Urinary protein \< 2+, or urinary protein ≥ 2+ but with 24-hour protein quantification ≤ 1.0 g

‣ Cardiac function:Left ventricular ejection fraction (LVEF) ≥ 50%; No clinically significant abnormal ECG findings (chronic atrial fibrillation is allowed, provided it does not require medication);

• Capable of full communication with the investigator, with the ability to understand and comply with study requirements, and able to understand and sign the informed consent form (ICF).

⁃ ≥18 years

Locations
Other Locations
China
Peking University Cancer Hospital
RECRUITING
Beijing
Contact Information
Primary
Lin Professor, M.D
Linshenpku@163.com
010 88196561
Time Frame
Start Date: 2024-11-18
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 14
Treatments
Experimental: dose level #1
Starting dose, 0.05 ug/kg
Experimental: dose level #2
dose escalation, 0.5 ug/kg
Experimental: dose level #3
dose escalation, 3.0 ug/kg
Experimental: dose level #4
dose escalation, 15.0 ug/kg
Experimental: dose level #5
dose escalation, 30.0 ug/kg
Experimental: dose level #6
dose escalation, 45.0 ug/kg
Related Therapeutic Areas
Sponsors
Collaborators: METiS Pharmaceuticals
Leads: Shen Lin

This content was sourced from clinicaltrials.gov

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