Status:
UNKNOWN
A Clinical Study of mRNA Vaccine (ABOR2014/IPM511) in Patients With Advanced Hepatocellular Carcinoma
Lead Sponsor:
Peking Union Medical College Hospital
Conditions:
Advanced Hepatocellular Carcinoma
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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 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
- Known allergy to any of the components of the investigational product;
- History of topical treatment with mRNA products or treatment with mRNA vaccines;
- 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);
- History of anti-tumor therapies within 4 weeks before the first dose;
- 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;
- History of organ transplant, bone marrow transplant, or hematopoietic stem cell transplant;
- History of hemorrhagic diseases such as anaphylactoid purpura, Haemophilia and aplastic anemia;
- History of live attenuated vaccines within 30 days before the first dose;
- Central nervous system (CNS) metastases that are symptomatic, untreated, or require continuous treatment;
- Toxicological events (except alopecia and pigmentation) have not recovered to baseline or NCI-CTCAE v5.0 grade 0-1 after prior anti-tumor therapies;
- History of autoimmune disorders;
- History of immediate hypersensitivity, eczema that cannot be controlled by topical corticosteroids, or asthma;
- Uncontrollable concomitant diseases;
- Active infections currently requiring systemic anti-infective therapy; active pulmonary tuberculosis;
- Known history of human immunodeficiency virus (HIV) positive or treponema pallidum positive;
- Patients with other conditions that are not suitable for participation in the study at the discretion of the investigator.
Key Trial Info
Start Date :
July 10 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT05981066
Start Date
July 10 2023
End Date
December 31 2025
Last Update
August 8 2023
Active Locations (1)
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1
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100730