A Clinical Study of mRNA Vaccine (ABOR2014/IPM511) in Patients With Advanced Hepatocellular Carcinoma

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Enrolling

Conditions: Advanced Hepatocellular Carcinoma

Treatments: Drug: Neoantigen vaccine, I.M injection

Study type: Interventional

Funder types: Other

Identifiers

NCT05981066

J-23PJ957

Details and patient eligibility

About

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.

Enrollment: 48 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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;

10. 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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48 participants in 1 patient group

IPM511 monotherapy

Experimental group

Description:

3+3 dose excalation. Paticipants will receive two cycle (QWX4 per cycle) IPM511 injection，I.M injection

Treatment:

Drug: Neoantigen vaccine, I.M injection