xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05981066</url>
    </required_header>
    <id_info>
      <org_study_id>J-23PJ957</org_study_id>
      <nct_id>NCT05981066</nct_id>
    </id_info>
    <brief_title>A Clinical Study of mRNA Vaccine (ABOR2014/IPM511) in Patients With Advanced Hepatocellular Carcinoma</brief_title>
    <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</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Peking Union Medical College Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Peking Union Medical College Hospital</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This is an open label, single-site, investigator-initiated trial designed to evaluate the&#xD;
        safety, tolerability and preliminary efficacy of ABOR2014(IPM511) injection in relapsed/&#xD;
        refactory HCC.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 10, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Sequential Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Incidence and severity of adverse events (AE)</measure>
      <time_frame>up to 12 months</time_frame>
      <description>AE assessed according to Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Clinically significant abnormal changes in vital signs</measure>
      <time_frame>up to 12 months</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Clinically significant abnormal changes in laboratory tests</measure>
      <time_frame>up to 12 months</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Maximum Plasma Concentration [Cmax] of IPM511</measure>
      <time_frame>up to 12 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time of Maximum Plasma Concentration [Tmax] of IPM511</measure>
      <time_frame>up to 12 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Half-time of Plasma Concentration [T1/2] of IPM511</measure>
      <time_frame>up to 12 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Antigen-specific T-cell responses in peripheral blood</measure>
      <time_frame>up to 12 months</time_frame>
      <description>Detected by Tetramer or TCRseq or Enzyme-linked Immunospot Assay(ELISPOT)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change of Circulating tumor DNA (ctDNA) status (every 6 weeks)</measure>
      <time_frame>up to 12 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Objective Response Rate, ORR</measure>
      <time_frame>up to 12 months</time_frame>
      <description>ORR is Defined as the number of patients with a complete response (CR) or partial response(PR) .</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Duration of Response, DoR</measure>
      <time_frame>up to 12 months</time_frame>
      <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).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Progress Free Survival, PFS</measure>
      <time_frame>up to 12 months</time_frame>
      <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).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Overall Survival, OS</measure>
      <time_frame>up to 12 months</time_frame>
      <description>OS is defined as time between the date of first dose of IPM511 and the date of death due to any cause.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">48</enrollment>
    <condition>Advanced Hepatocellular Carcinoma</condition>
    <arm_group>
      <arm_group_label>IPM511 monotherapy</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>3+3 dose excalation. Paticipants will receive two cycle (QWX4 per cycle) IPM511 injection，I.M injection</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Neoantigen vaccine, I.M injection</intervention_name>
      <description>Patients will receive a fixed applicable dose of ABOR2014(IPM511) administered.</description>
      <arm_group_label>IPM511 monotherapy</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Subjects who understand and voluntarily sign the informed consent form;&#xD;
  &#xD;
            2. Male or female subjects ≥ 18 years old;&#xD;
  &#xD;
            3. Patients with pathological or cytological evidence of locally advanced or&#xD;
               hepatocellular carcinoma, who have failed or are intolerant of previous standard&#xD;
               treatments;&#xD;
  &#xD;
            4. At least one measurable lesion judged according to the RECIST version 1.1 standard.&#xD;
  &#xD;
            5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1 (inclusive);&#xD;
  &#xD;
            6. Life expectancy ≥ 12 weeks;&#xD;
  &#xD;
            7. HLA typing: A-02;&#xD;
  &#xD;
            8. Laboratory tests at screening shall meet the following requirements:&#xD;
  &#xD;
                 -  Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L;&#xD;
  &#xD;
                 -  Platelet count (PLT) ≥ 90 × 10^9/L;&#xD;
  &#xD;
                 -  Hemoglobin (Hb) ≥ 90 g/L;&#xD;
  &#xD;
                 -  Total bilirubin (TBIL) ≤ 3 × ULN;&#xD;
  &#xD;
                 -  Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 5 × ULN;&#xD;
  &#xD;
                 -  Blood creatinine (Cr) ≤ 1.5 × ULN or creatinine clearance (calculated based on&#xD;
                    Cockcroft-Gault formula) ≥ 45 mL/min;&#xD;
  &#xD;
                 -  International normalized ratio (INR), prothrombin time (PT), and activated&#xD;
                    partial thromboplastin time (aPTT) ≤ 1.5 × ULN;&#xD;
  &#xD;
                 -  QTc interval (calculated based on Fridericia's formula) ≤ 450 ms for males and ≤&#xD;
                    470 ms for females;&#xD;
  &#xD;
            9. For subjects with hepatitis B-related primary hepatocellular carcinoma (HBV-HCC) or&#xD;
               hepatitis C-related primary hepatocellular carcinoma (HCV-HCC), those who are with the&#xD;
               following conditions are eligible to be enrolled:&#xD;
  &#xD;
                 -  HBV-HCC: resolved HBV infection with concomitant antiviral therapy;&#xD;
  &#xD;
                 -  HCV-HCC: resolved or active HCV infection , where concomitant antiviral therapy&#xD;
                    may be given for active HCV infection;&#xD;
  &#xD;
          9. For patients of childbearing potential (male or female), effective contraceptive&#xD;
          measures shall be taken during the study treatment and within 3 months after the last dose.&#xD;
          For women of childbearing potential, a negative serum/urine HCG test result within 7 days&#xD;
          prior to study enrollment shall be provided.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Known allergy to any of the components of the investigational product;&#xD;
  &#xD;
            2. History of topical treatment with mRNA products or treatment with mRNA vaccines;&#xD;
  &#xD;
            3. Patients with a history of major operations within 4 weeks before the first dose, have&#xD;
               a plan of major operations during the study (at the investigator's discretion);&#xD;
  &#xD;
            4. History of anti-tumor therapies within 4 weeks before the first dose;&#xD;
  &#xD;
            5. History of receiving immunosuppressive drugs within 4 weeks before the first dose,&#xD;
               except for corticosteroid nasal sprays, inhalants, and systemic prednisone at a dose&#xD;
               of ≤ 10 mg/day or similar drugs at equivalent doses;&#xD;
  &#xD;
            6. History of organ transplant, bone marrow transplant, or hematopoietic stem cell&#xD;
               transplant;&#xD;
  &#xD;
            7. History of hemorrhagic diseases such as anaphylactoid purpura, Haemophilia and&#xD;
               aplastic anemia;&#xD;
  &#xD;
            8. History of live attenuated vaccines within 30 days before the first dose;&#xD;
  &#xD;
            9. Central nervous system (CNS) metastases that are symptomatic, untreated, or require&#xD;
               continuous treatment;&#xD;
  &#xD;
           10. Toxicological events (except alopecia and pigmentation) have not recovered to baseline&#xD;
               or NCI-CTCAE v5.0 grade 0-1 after prior anti-tumor therapies;&#xD;
  &#xD;
           11. History of autoimmune disorders;&#xD;
  &#xD;
           12. History of immediate hypersensitivity, eczema that cannot be controlled by topical&#xD;
               corticosteroids, or asthma;&#xD;
  &#xD;
           13. Uncontrollable concomitant diseases;&#xD;
  &#xD;
           14. Active infections currently requiring systemic anti-infective therapy; active&#xD;
               pulmonary tuberculosis;&#xD;
  &#xD;
           15. Known history of human immunodeficiency virus (HIV) positive or treponema pallidum&#xD;
               positive;&#xD;
  &#xD;
           16. Patients with other conditions that are not suitable for participation in the study at&#xD;
               the discretion of the investigator.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Zhao haitao, Dr</last_name>
      <phone>010-69156114</phone>
      <email>zhaoht@pumch.cn</email>
    </overall_contact>
    <location>
      <facility>
        <name>Peking Union Medical College Hospital, Chinese Academy of Medical Sciences</name>
        <address>
          <city>Beijing</city>
          <state>Beijing</state>
          <zip>100730</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>tong li, PhD</last_name>
        <email>tong.li@immmupeutics.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 5, 2023</study_first_submitted>
    <study_first_submitted_qc>July 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 8, 2023</study_first_posted>
    <last_update_submitted>July 31, 2023</last_update_submitted>
    <last_update_submitted_qc>July 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>mRNA vaccine</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Carcinoma</mesh_term>
      <mesh_term>Carcinoma, Hepatocellular</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05981066
  org study id: J-23PJ957
  nct id: NCT05981066
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  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.
  allocation: N/A
  intervention model: Sequential Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Incidence and severity of adverse events (AE)
  time frame: 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
  time frame: up to 12 months
  measure: Clinically significant abnormal changes in laboratory tests
  time frame: up to 12 months
  measure: Maximum Plasma Concentration [Cmax] of IPM511
  time frame: up to 12 months
  measure: Time of Maximum Plasma Concentration [Tmax] of IPM511
  time frame: up to 12 months
  measure: Half-time of Plasma Concentration [T1/2] of IPM511
  time frame: up to 12 months
  measure: Antigen-specific T-cell responses in peripheral blood
  time frame: 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)
  time frame: up to 12 months
  measure: Objective Response Rate, ORR
  time frame: 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
  time frame: 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
  time frame: 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
  time frame: 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.
  arm group label: IPM511 monotherapy
  arm group type: Experimental
  description: 3+3 dose excalation. Paticipants will receive two cycle (QWX4 per cycle) IPM511 injection，I.M injection
  intervention type: Drug
  intervention name: Neoantigen vaccine, I.M injection
  description: Patients will receive a fixed applicable dose of ABOR2014(IPM511) administered.
  arm group label: IPM511 monotherapy
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Zhao haitao, Dr
  phone: 010-69156114
  email: zhaoht@pumch.cn
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Sponsor
  mesh term: Carcinoma
  mesh term: Carcinoma, Hepatocellular
  sharing ipd: No