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

NCT05981066 | Unknown

• 1 other identifier: J-23PJ957
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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

Keywords

mRNA vaccine

Outcome Measures

Primary Outcomes (3)

• Incidence and severity of adverse events (AE)

  AE assessed according to Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0).

  up to 12 months

• Clinically significant abnormal changes in vital signs

  up to 12 months

• Clinically significant abnormal changes in laboratory tests

  up to 12 months

Secondary Outcomes (9)

• Maximum Plasma Concentration [Cmax] of IPM511

  up to 12 months

• Time of Maximum Plasma Concentration [Tmax] of IPM511

  up to 12 months

• Half-time of Plasma Concentration [T1/2] of IPM511

  up to 12 months

• Antigen-specific T-cell responses in peripheral blood

  up to 12 months

• Change of Circulating tumor DNA (ctDNA) status (every 6 weeks)

  up to 12 months

Study Arms (1)

IPM511 monotherapy

EXPERIMENTAL

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

Drug: Neoantigen vaccine, I.M injection

Interventions

Neoantigen vaccine, I.M injection DRUG

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

IPM511 monotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100730, China

RECRUITING

Central Study Contacts

Zhao haitao, Dr

CONTACT

010-69156114; zhaoht@pumch.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2023
• First Posted: August 8, 2023
• Study Start: July 10, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: August 8, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)