Ignite Creation Date:
2025-12-24 @ 4:17 PM
Ignite Modification Date:
2025-12-28 @ 1:10 AM
Study NCT ID:
NCT05981066
Status:
RECRUITING
Last Update Posted:
2023-08-08
First Post:
2023-07-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Study of mRNA Vaccine (ABOR2014/IPM511) in Patients With Advanced Hepatocellular Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 48}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-07-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-07-31', 'studyFirstSubmitDate': '2023-07-05', 'studyFirstSubmitQcDate': '2023-07-31', 'lastUpdatePostDateStruct': {'date': '2023-08-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence and severity of adverse events (AE)', 'timeFrame': 'up to 12 months', 'description': 'AE assessed according to Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0).'}, {'measure': 'Clinically significant abnormal changes in vital signs', 'timeFrame': 'up to 12 months'}, {'measure': 'Clinically significant abnormal changes in laboratory tests', 'timeFrame': 'up to 12 months'}], 'secondaryOutcomes': [{'measure': 'Maximum Plasma Concentration [Cmax] of IPM511', 'timeFrame': 'up to 12 months'}, {'measure': 'Time of Maximum Plasma Concentration [Tmax] of IPM511', 'timeFrame': 'up to 12 months'}, {'measure': 'Half-time of Plasma Concentration [T1/2] of IPM511', 'timeFrame': 'up to 12 months'}, {'measure': 'Antigen-specific T-cell responses in peripheral blood', 'timeFrame': 'up to 12 months', 'description': 'Detected by Tetramer or TCRseq or Enzyme-linked Immunospot Assay(ELISPOT)'}, {'measure': 'Change of Circulating tumor DNA (ctDNA) status (every 6 weeks)', 'timeFrame': 'up to 12 months'}, {'measure': 'Objective Response Rate, ORR', 'timeFrame': 'up to 12 months', 'description': 'ORR is Defined as the number of patients with a complete response (CR) or partial response(PR) .'}, {'measure': 'Duration of Response, DoR', 'timeFrame': 'up to 12 months', 'description': '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).'}, {'measure': 'Progress Free Survival, PFS', 'timeFrame': 'up to 12 months', 'description': '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).'}, {'measure': 'Overall Survival, OS', 'timeFrame': 'up to 12 months', 'description': 'OS is defined as time between the date of first dose of IPM511 and the date of death due to any cause.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['mRNA vaccine'], 'conditions': ['Advanced Hepatocellular Carcinoma']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Subjects who understand and voluntarily sign the informed consent form;\n2. Male or female subjects ≥ 18 years old;\n3. Patients with pathological or cytological evidence of locally advanced or hepatocellular carcinoma, who have failed or are intolerant of previous standard treatments;\n4. At least one measurable lesion judged according to the RECIST version 1.1 standard.\n5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1 (inclusive);\n6. Life expectancy ≥ 12 weeks;\n7. HLA typing: A-02;\n8. Laboratory tests at screening shall meet the following requirements:\n\n * Absolute neutrophil count (ANC) ≥ 1.5 × 10\\^9/L;\n * Platelet count (PLT) ≥ 90 × 10\\^9/L;\n * Hemoglobin (Hb) ≥ 90 g/L;\n * Total bilirubin (TBIL) ≤ 3 × ULN;\n * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 5 × ULN;\n * Blood creatinine (Cr) ≤ 1.5 × ULN or creatinine clearance (calculated based on Cockcroft-Gault formula) ≥ 45 mL/min;\n * International normalized ratio (INR), prothrombin time (PT), and activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN;\n * QTc interval (calculated based on Fridericia's formula) ≤ 450 ms for males and ≤ 470 ms for females;\n9. 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:\n\n * HBV-HCC: resolved HBV infection with concomitant antiviral therapy;\n * HCV-HCC: resolved or active HCV infection , where concomitant antiviral therapy may be given for active HCV infection;\n\n9\\. 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.\n\nExclusion Criteria:\n\n1. Known allergy to any of the components of the investigational product;\n2. History of topical treatment with mRNA products or treatment with mRNA vaccines;\n3. 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);\n4. History of anti-tumor therapies within 4 weeks before the first dose;\n5. 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;\n6. History of organ transplant, bone marrow transplant, or hematopoietic stem cell transplant;\n7. History of hemorrhagic diseases such as anaphylactoid purpura, Haemophilia and aplastic anemia;\n8. History of live attenuated vaccines within 30 days before the first dose;\n9. Central nervous system (CNS) metastases that are symptomatic, untreated, or require continuous treatment;\n10. Toxicological events (except alopecia and pigmentation) have not recovered to baseline or NCI-CTCAE v5.0 grade 0-1 after prior anti-tumor therapies;\n11. History of autoimmune disorders;\n12. History of immediate hypersensitivity, eczema that cannot be controlled by topical corticosteroids, or asthma;\n13. Uncontrollable concomitant diseases;\n14. Active infections currently requiring systemic anti-infective therapy; active pulmonary tuberculosis;\n15. Known history of human immunodeficiency virus (HIV) positive or treponema pallidum positive;\n16. Patients with other conditions that are not suitable for participation in the study at the discretion of the investigator."}, 'identificationModule': {'nctId': 'NCT05981066', 'briefTitle': 'A Clinical Study of mRNA Vaccine (ABOR2014/IPM511) in Patients With Advanced Hepatocellular Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Peking Union Medical College Hospital'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'J-23PJ957'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IPM511 monotherapy', 'description': '3+3 dose excalation. Paticipants will receive two cycle (QWX4 per cycle) IPM511 injection，I.M injection', 'interventionNames': ['Drug: Neoantigen vaccine, I.M injection']}], 'interventions': [{'name': 'Neoantigen vaccine, I.M injection', 'type': 'DRUG', 'description': 'Patients will receive a fixed applicable dose of ABOR2014(IPM511) administered.', 'armGroupLabels': ['IPM511 monotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100730', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'tong li, PhD', 'role': 'CONTACT', 'email': 'tong.li@immmupeutics.com'}], 'facility': 'Peking Union Medical College Hospital, Chinese Academy of Medical Sciences', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Zhao haitao, Dr', 'role': 'CONTACT', 'email': 'zhaoht@pumch.cn', 'phone': '010-69156114'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking Union Medical College Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}