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

NCT ID: NCT05981066

Last Updated: 2023-08-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-10
• Study Completion Date: 2025-12-31

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.

Conditions

Advanced Hepatocellular Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IPM511 monotherapy

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

Group Type: EXPERIMENTAL

Neoantigen vaccine, I.M injection

Intervention Type: DRUG

Patients will receive a fixed applicable dose of ABOR2014(IPM511) administered.

Interventions

Neoantigen vaccine, I.M injection

Patients will receive a fixed applicable dose of ABOR2014(IPM511) administered.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking Union Medical College Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Zhao haitao, Dr

Role: CONTACT

zhaoht@pumch.cn

010-69156114

Facility Contacts

tong li, PhD

Role: primary

tong.li@immmupeutics.com

Other Identifiers

J-23PJ957

Identifier Type: -

Identifier Source: org_study_id