Advanced hepatocellular carcinoma
Conditions
Interventions
Single arm:ABOR2014 Injection(IPM511)
Sponsors
Peking Union Medical College Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Subjects who understand and voluntarily sign the informed consent form; Male or female subjects = 18 years old; Patients with pathological or cytological evidence of locally advanced or hepatocellular carcinoma, who have failed or are intolerant of previous standard treatments; At least one measurable lesion judged according to the RECIST version 1.1 standard. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1 (inclusive); Life expectancy = 12 weeks; HLA typing: A-02; 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; 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 infectionwith 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and Tolerability;Biological activity;Pharmacokinetic parameters; | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluated tumor progression based on iRECIST criteria; | — |
Countries
China
Contacts
Public ContactZhao Haitao
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Outcome results
None listed