An Open, Single-center, Multiple-dose, Dose-increasing and Dose-expanding Clinical Study to Observe and Evaluate the Safety, Tolerance, Immunokinetics and Preliminary Effectiveness of ABOR2014 Injection (IPM511) in the Treatment of Advanced Hepatocellular Carcinoma

J-23PJ957

This is an open label, single-site, investigator-initiated trial designed to evaluate the safety, tolerability and preliminary efficacy of ABOR2014(IPM511) injection in relapsed/ refactory HCC.

2023-07-10

2024-12-31

2025-12-31

Recruiting

48

Inclusion Criteria: 1. Subjects who understand and voluntarily sign the informed consent form; 2. Male or female subjects ≥ 18 years old; 3. Patients with pathological or cytological evidence of locally advanced or hepatocellular carcinoma, who have failed or are intolerant of previous standard treatments; 4. At least one measurable lesion judged according to the RECIST version 1.1 standard. 5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1 (inclusive); 6. Life expectancy ≥ 12 weeks; 7. HLA typing: A-02; 8. Laboratory tests at screening shall meet the following requirements: * Absolute neutrophil count (ANC) ≥ 1.5 × 10\^9/L; * Platelet count (PLT) ≥ 90 × 10\^9/L; * Hemoglobin (Hb) ≥ 90 g/L; * Total bilirubin (TBIL) ≤ 3 × ULN; * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 5 × ULN; * Blood creatinine (Cr) ≤ 1.5 × ULN or creatinine clearance (calculated based on Cockcroft-Gault formula) ≥ 45 mL/min; * International normalized ratio (INR), prothrombin time (PT), and activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN; * QTc interval (calculated based on Fridericia's formula) ≤ 450 ms for males and ≤ 470 ms for females; 9. For subjects with hepatitis B-related primary hepatocellular carcinoma (HBV-HCC) or hepatitis C-related primary hepatocellular carcinoma (HCV-HCC), those who are with the following conditions are eligible to be enrolled: * HBV-HCC: resolved HBV infection with concomitant antiviral therapy; * HCV-HCC: resolved or active HCV infection , where concomitant antiviral therapy may be given for active HCV infection; 9. For patients of childbearing potential (male or female), effective contraceptive measures shall be taken during the study treatment and within 3 months after the last dose. For women of childbearing potential, a negative serum/urine HCG test result within 7 days prior to study enrollment shall be provided. Exclusion Criteria: 1. Known allergy to any of the components of the investigational product; 2. History of topical treatment with mRNA products or treatment with mRNA vaccines; 3. Patients with a history of major operations within 4 weeks before the first dose, have a plan of major operations during the study (at the investigator's discretion); 4. History of anti-tumor therapies within 4 weeks before the first dose; 5. History of receiving immunosuppressive drugs within 4 weeks before the first dose, except for corticosteroid nasal sprays, inhalants, and systemic prednisone at a dose of ≤ 10 mg/day or similar drugs at equivalent doses; 6. History of organ transplant, bone marrow transplant, or hematopoietic stem cell transplant; 7. History of hemorrhagic diseases such as anaphylactoid purpura, Haemophilia and aplastic anemia; 8. History of live attenuated vaccines within 30 days before the first dose; 9. Central nervous system (CNS) metastases that are symptomatic, untreated, or require continuous treatment; 10. Toxicological events (except alopecia and pigmentation) have not recovered to baseline or NCI-CTCAE v5.0 grade 0-1 after prior anti-tumor therapies; 11. History of autoimmune disorders; 12. History of immediate hypersensitivity, eczema that cannot be controlled by topical corticosteroids, or asthma; 13. Uncontrollable concomitant diseases; 14. Active infections currently requiring systemic anti-infective therapy; active pulmonary tuberculosis; 15. Known history of human immunodeficiency virus (HIV) positive or treponema pallidum positive; 16. Patients with other conditions that are not suitable for participation in the study at the discretion of the investigator.

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SEQUENTIAL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 48, 'type': 'ESTIMATED'}}

2023-08-08