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/NCT06007482</url>
    </required_header>
    <id_info>
      <org_study_id>ES009-1001</org_study_id>
      <nct_id>NCT06007482</nct_id>
    </id_info>
    <brief_title>A Study of ES009 in Subjects With Locally Advanced or Metastatic Solid Tumors</brief_title>
    <official_title>An Open-Label, Multicenter, First-in-Human, Phase 1 Study of ES009 in Subjects With Locally Advanced or Metastatic Solid Tumors</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Elpiscience Biopharma Australia Pty. Ltd.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Elpiscience Biopharma, Ltd.</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>
        The goal of this clinical trial is to evaluate the safety, tolerability, pharmacokinetics,&#xD;
        pharmacodynamics, and preliminary clinical activity of ES009 administered intravenously to&#xD;
        subjects with advanced solid tumors.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        ES009 is a recombinant humanized IgG4 monoclonal antibody that specifically targets and&#xD;
        blocks LILRB2. By reprograming suppressive myeloid cells into pro-inflammatory phenotypes,&#xD;
        ES009 reshapes the immunosuppressive tumor microenvironment into an immune-favorable one to&#xD;
        combat cancer development and progression.&#xD;
  &#xD;
        This is a first-in-human, open-label, multicenter, non-randomized study designed to determine&#xD;
        the maximum tolerated dose (MTD)/maximum administered dose (MAD), optimal biological dose&#xD;
        (OBD), and recommended phase 2 dose (RP2D) of ES009 by evaluating the safety, tolerability,&#xD;
        pharmacokinetics, pharmacodynamics, and preliminary clinical activity of ES009 administered&#xD;
        intravenously to subjects with advanced solid tumors.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">September 7, 2023</start_date>
    <completion_date type="Anticipated">August 15, 2025</completion_date>
    <primary_completion_date type="Anticipated">August 15, 2024</primary_completion_date>
    <phase>Phase 1</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>The frequency and severity of adverse events of ES009</measure>
      <time_frame>1-3 years</time_frame>
      <description>Adverse events will be assessed and assigned by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Maximum tolerated dose (MTD) of ES009</measure>
      <time_frame>1-3 years</time_frame>
      <description>The MTD of ES009 will be determined.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Optimal biological dose (OBD) of ES009</measure>
      <time_frame>1-3 years</time_frame>
      <description>The OBD of ES009 will be determined.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Recommended phase 2 dose (RP2D) of ES009</measure>
      <time_frame>1-3 years</time_frame>
      <description>The RP2D of ES009 will be determined.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Maximum administered dose (MAD) of ES009</measure>
      <time_frame>1-3 years</time_frame>
      <description>The MAD of ES009 will be determined.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Maximum observed serum concentration (Cmax) of ES009</measure>
      <time_frame>1-3 years</time_frame>
      <description>Maximum observed serum concentration (Cmax) of ES009 will be measured.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Trough observed serum concentration (Ctrough) of ES009</measure>
      <time_frame>1-3 years</time_frame>
      <description>Trough observed serum concentration (Ctrough)of ES009 will be measured.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Area under the serum concentration time curve (AUC) of ES009</measure>
      <time_frame>1-3 years</time_frame>
      <description>Area under the serum concentration time curve (AUC) of ES009 will be measured.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to Cmax (Tmax) of ES009</measure>
      <time_frame>1-3 years</time_frame>
      <description>Time to Cmax (Tmax) of ES009 will be measured.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The terminal elimination half life of ES009</measure>
      <time_frame>1-3 years</time_frame>
      <description>The terminal elimination half-life (t 1/2) of ES009 will be measured.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Immunogenicity of ES009</measure>
      <time_frame>1-3 years</time_frame>
      <description>Frequency of anti-drug antibodies (ADA) against ES009 will be determined.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Preliminary antitumor activity of ES009</measure>
      <time_frame>1-3 years</time_frame>
      <description>Tumor response will be measured by the revised Response Evaluation Criteria in Solid Tumors version 1.1 (RECISTv1.1) by Investigator assessment.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">20</enrollment>
    <condition>Advanced Solid Tumor</condition>
    <arm_group>
      <arm_group_label>Dose Escalation Cohort</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>ES009 monotherapy dose level will be escalated in participants with advanced solid tumors.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>ES009</intervention_name>
      <description>ES009 is administered via intravenous infusion, once every 21 days.</description>
      <arm_group_label>Dose Escalation Cohort</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Capable of giving signed informed consent.&#xD;
  &#xD;
            -  Histological or cytological documentation of unresectable locally advanced or&#xD;
               metastatic solid tumors, if 1) disease has progressed despite standard therapy, and no&#xD;
               further standard therapy exists; or 2) standard therapy has proven to be ineffective&#xD;
               or intolerable or is considered inappropriate.&#xD;
  &#xD;
            -  At least one measurable lesion per RECIST v1.1.&#xD;
  &#xD;
            -  Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1.&#xD;
  &#xD;
            -  Life expectancy of at least 12 weeks.&#xD;
  &#xD;
            -  Adequate hematologic, hepatic, renal and coagulation function per protocol.&#xD;
  &#xD;
            -  Male and female subjects of childbearing potential must be willing to completely&#xD;
               abstain or agree to use a highly effective method of contraception per protocol.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Any prior therapy targeting LILRB2.&#xD;
  &#xD;
            -  Receipt of any investigational therapies within 28 days or 5 half-lives prior to the&#xD;
               first dose of study drug.&#xD;
  &#xD;
            -  Prior treatment with the following therapies:• Anticancer therapy within 28 days or 5&#xD;
               half-lives of the drug prior to the first dose of study drug, whichever is shorter.&#xD;
               Exception: hormonal replacement therapy.• A wash out of at least 2 weeks before the&#xD;
               start of study drug for radiation to the extremities and 4 weeks for radiation to the&#xD;
               chest, brain, or visceral organs is required.&#xD;
  &#xD;
            -  Prior allogeneic or autologous bone marrow transplantation or solid organ&#xD;
               transplantation.&#xD;
  &#xD;
            -  Toxicity from previous anticancer treatment per protocol.&#xD;
  &#xD;
            -  Treatment with systemic immunosuppressive medications within 4 weeks prior to the&#xD;
               first dose of study drug with certain exceptions.&#xD;
  &#xD;
            -  Subjects who received transfusion of blood products (including platelets or red blood&#xD;
               cells), G-CSF, GM-CSF, recombinant erythropoietin, or recombinant thrombopoietin&#xD;
               within 14 days prior to the first dose of study treatment.&#xD;
  &#xD;
            -  Major surgery within 4 weeks prior to the first dose of study treatment.&#xD;
  &#xD;
            -  Live vaccine therapies within 4 weeks prior to the first dose of study treatment.&#xD;
  &#xD;
            -  Recent history of allergen desensitization therapy within 4 weeks prior to the first&#xD;
               dose of study treatment.&#xD;
  &#xD;
            -  Known allergies to CHO-produced antibodies.&#xD;
  &#xD;
            -  Invasive malignancy or history of invasive malignancy other than disease under study&#xD;
               within the last two years with certain exceptions.&#xD;
  &#xD;
            -  CNS metastases with certain exceptions.&#xD;
  &#xD;
            -  Active autoimmune disease or documented history of autoimmune disease that required&#xD;
               systemic steroids or other immunosuppressive medications.&#xD;
  &#xD;
            -  Active interstitial lung disease (ILD) or pneumonitis requiring treatment with&#xD;
               steroids or other immunosuppressive medications.&#xD;
  &#xD;
            -  Active infection requiring systemic therapy, known human immunodeficiency virus (HIV)&#xD;
               infection, or positive test for hepatitis B active infection (HBsAg) or hepatitis C&#xD;
               active infection (hepatitis C antibody).&#xD;
  &#xD;
            -  Current active liver or biliary disease (with the exception of Gilbert's syndrome or&#xD;
               asymptomatic gallstones, liver metastases, or otherwise stable chronic liver disease&#xD;
               per investigator assessment).&#xD;
  &#xD;
            -  History or evidence of cardiac abnormalities.&#xD;
  &#xD;
            -  Pregnant or nursing females.&#xD;
  &#xD;
            -  Any known, documented, or suspected history of illicit substance abuse that would&#xD;
               preclude subject from participation, unless clinically justified.&#xD;
  &#xD;
            -  Any other disease or clinically significant abnormality in laboratory parameters,&#xD;
               including serious medical or psychiatric illness/condition, which in the judgment of&#xD;
               the Investigator might compromise the safety of the subject or integrity of the study,&#xD;
               interfere with the subject participation in the trial or compromise the trial&#xD;
               objectives.&#xD;
  &#xD;
            -  Involvement in the planning and/or conduct of the study (applies to both Sponsor/CRO&#xD;
               staff and staff at the study site)&#xD;
  &#xD;
            -  Judgment by the Investigator that the subject is unlikely to comply with study&#xD;
               procedures, restrictions and requirements.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Sydney Gong, PM</last_name>
      <phone>86-021-50651310</phone>
      <email>clinical-operation@elpiscience.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Peninsula and South Eastern Oncology and Haematology Group</name>
        <address>
          <city>Frankston</city>
          <country>Australia</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Vinod Ganju</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>St George Private Hospital</name>
        <address>
          <city>Kogarah</city>
          <country>Australia</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Paul De Souza</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Scientia Clinical Research</name>
        <address>
          <city>Randwick</city>
          <country>Australia</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Charlotte Lemech</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Sunshine Coast University Private Hospital</name>
        <address>
          <city>Sunshine Coast</city>
          <country>Australia</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Michelle Morris</last_name>
      </contact>
    </location>
    <location_countries>
      <country>Australia</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 10, 2023</study_first_submitted>
    <study_first_submitted_qc>August 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>September 12, 2023</last_update_submitted>
    <last_update_submitted_qc>September 12, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Leukocyte immunoglobulin-like receptor B2 (LILRB2)</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Neoplasms</mesh_term>
    </condition_browse>
    <!-- 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/NCT06007482
  org study id: ES009-1001
  nct id: NCT06007482
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is to evaluate the safety, tolerability, pharmacokinetics,
        pharmacodynamics, and preliminary clinical activity of ES009 administered intravenously to
        subjects with advanced solid tumors.
  ES009 is a recombinant humanized IgG4 monoclonal antibody that specifically targets and
        blocks LILRB2. By reprograming suppressive myeloid cells into pro-inflammatory phenotypes,
        ES009 reshapes the immunosuppressive tumor microenvironment into an immune-favorable one to
        combat cancer development and progression.
  
        This is a first-in-human, open-label, multicenter, non-randomized study designed to determine
        the maximum tolerated dose (MTD)/maximum administered dose (MAD), optimal biological dose
        (OBD), and recommended phase 2 dose (RP2D) of ES009 by evaluating the safety, tolerability,
        pharmacokinetics, pharmacodynamics, and preliminary clinical activity of ES009 administered
        intravenously to subjects with advanced solid tumors.
  allocation: N/A
  intervention model: Sequential Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: The frequency and severity of adverse events of ES009
  time frame: 1-3 years
  description: Adverse events will be assessed and assigned by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0.
  measure: Maximum tolerated dose (MTD) of ES009
  time frame: 1-3 years
  description: The MTD of ES009 will be determined.
  measure: Optimal biological dose (OBD) of ES009
  time frame: 1-3 years
  description: The OBD of ES009 will be determined.
  measure: Recommended phase 2 dose (RP2D) of ES009
  time frame: 1-3 years
  description: The RP2D of ES009 will be determined.
  measure: Maximum administered dose (MAD) of ES009
  time frame: 1-3 years
  description: The MAD of ES009 will be determined.
  measure: Maximum observed serum concentration (Cmax) of ES009
  time frame: 1-3 years
  description: Maximum observed serum concentration (Cmax) of ES009 will be measured.
  measure: Trough observed serum concentration (Ctrough) of ES009
  time frame: 1-3 years
  description: Trough observed serum concentration (Ctrough)of ES009 will be measured.
  measure: Area under the serum concentration time curve (AUC) of ES009
  time frame: 1-3 years
  description: Area under the serum concentration time curve (AUC) of ES009 will be measured.
  measure: Time to Cmax (Tmax) of ES009
  time frame: 1-3 years
  description: Time to Cmax (Tmax) of ES009 will be measured.
  measure: The terminal elimination half life of ES009
  time frame: 1-3 years
  description: The terminal elimination half-life (t 1/2) of ES009 will be measured.
  measure: Immunogenicity of ES009
  time frame: 1-3 years
  description: Frequency of anti-drug antibodies (ADA) against ES009 will be determined.
  measure: Preliminary antitumor activity of ES009
  time frame: 1-3 years
  description: Tumor response will be measured by the revised Response Evaluation Criteria in Solid Tumors version 1.1 (RECISTv1.1) by Investigator assessment.
  arm group label: Dose Escalation Cohort
  arm group type: Experimental
  description: ES009 monotherapy dose level will be escalated in participants with advanced solid tumors.
  intervention type: Drug
  intervention name: ES009
  description: ES009 is administered via intravenous infusion, once every 21 days.
  arm group label: Dose Escalation Cohort
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Sydney Gong, PM
  phone: 86-021-50651310
  email: clinical-operation@elpiscience.com
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Not yet recruiting
  contact: 
  facility: 
  status: Not yet recruiting
  contact: 
  facility: 
  status: Not yet recruiting
  contact: 
  country: Australia
  responsible party type: Sponsor
  mesh term: Neoplasms