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

Sponsor
Peking Union Medical College Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05981066
Collaborator
(none)
48
Enrollment
1
Location
1
Arm
29.7
Anticipated Duration (Months)
1.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Neoantigen vaccine, I.M injection
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
48 participants
Allocation:
N/A
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open, Single-center, Multiple-dose, Dose-increasing and Dose-expanding Clinical Study to Observe and Evaluate the Safety, Tolerance, Immunokinetics and Preliminary Effectiveness of ABOR2014 Injection (IPM511) in the Treatment of Advanced Hepatocellular Carcinoma
Actual Study Start Date :
Jul 10, 2023
Anticipated Primary Completion Date :
Dec 31, 2024
Anticipated Study Completion Date :
Dec 31, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: IPM511 monotherapy

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

Drug: Neoantigen vaccine, I.M injection
Patients will receive a fixed applicable dose of ABOR2014(IPM511) administered.

Outcome Measures

Primary Outcome Measures

  1. Incidence and severity of adverse events (AE) [up to 12 months]

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

  2. Clinically significant abnormal changes in vital signs [up to 12 months]

  3. Clinically significant abnormal changes in laboratory tests [up to 12 months]

Secondary Outcome Measures

  1. Maximum Plasma Concentration [Cmax] of IPM511 [up to 12 months]

  2. Time of Maximum Plasma Concentration [Tmax] of IPM511 [up to 12 months]

  3. Half-time of Plasma Concentration [T1/2] of IPM511 [up to 12 months]

  4. Antigen-specific T-cell responses in peripheral blood [up to 12 months]

    Detected by Tetramer or TCRseq or Enzyme-linked Immunospot Assay(ELISPOT)

  5. Change of Circulating tumor DNA (ctDNA) status (every 6 weeks) [up to 12 months]

  6. Objective Response Rate, ORR [up to 12 months]

    ORR is Defined as the number of patients with a complete response (CR) or partial response(PR) .

  7. Duration of Response, DoR [up to 12 months]

    DoR is defined as time from first tumor response(partial or complete) until either radiogical disease progress, clinical/ symptomatic disease progression or death (whichever is sooner).

  8. Progress Free Survival, PFS [up to 12 months]

    PFS is defined as time between the date of first dose of IPM511 and the date either radiogical disease progress, clinical/ symptomatic disease progression or death (whichever is sooner).

  9. Overall Survival, OS [up to 12 months]

    OS is defined as time between the date of first dose of IPM511 and the date of death due to any cause.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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;

  1. 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;

  1. 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Peking Union Medical College Hospital, Chinese Academy of Medical Sciences Beijing Beijing China 100730

Sponsors and Collaborators

  • Peking Union Medical College Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Peking Union Medical College Hospital
ClinicalTrials.gov Identifier:
NCT05981066
Other Study ID Numbers:
  • J-23PJ957
First Posted:
Aug 8, 2023
Last Update Posted:
Aug 8, 2023
Last Verified:
Jul 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Peking Union Medical College Hospital
mRNA vaccine
Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular

Study Results

No Results Posted as of Aug 8, 2023