<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/NCT04410224</url>
  </required_header>
  <id_info>
    <org_study_id>ASN004-101</org_study_id>
    <nct_id>NCT04410224</nct_id>
  </id_info>
  <brief_title>Study of ASN004 in Patients With Advanced Solid Tumors</brief_title>
  <acronym>ASN004</acronym>
  <official_title>An Open Label, Multicenter, Dose-Finding Clinical Phase 1 Study of ASN004 to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy in Patients With Advanced Malignant Solid Tumors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kirilys Therapeutics Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kirilys Therapeutics Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Participants in this study will receive ASN004 once every 3 weeks by intravenous infusion.&#xD;
      The study will test various doses of ASN004 to find out the highest safe dose to test in&#xD;
      future trials.&#xD;
&#xD;
      Eligible subjects will be sequentially enrolled in cohorts at escalated doses.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Eligible patients will be sequentially enrolled sequentially at escalating doses.&#xD;
&#xD;
      Dose escalation decisions will be based on the review of clinical safety and pharmacokinetic&#xD;
      (PD) and pharmacodynamics (PD) data and agreed upon by the Sponsor and investigators.&#xD;
&#xD;
      The maximum tolerated dose (MTD) will have an estimated DLT rate of &lt; 33%. Cohorts may be&#xD;
      expanded at any dose level or at the MTD for further evaluation of safety, or PK parameters&#xD;
      as required.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">April 8, 2022</start_date>
  <completion_date type="Anticipated">March 31, 2026</completion_date>
  <primary_completion_date type="Anticipated">March 31, 2025</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>
    <intervention_model_description>Escalating doses of ASN004</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Determine the maximum tolerated dose of ASN004</measure>
    <time_frame>first 21 days</time_frame>
    <description>The MTD will be determined by evaluating the number of subjects with treatment related adverse events (AEs) and DLTs.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Calculate the pharmacokinetic (PK) area under the plasma concentration of ASN004</measure>
    <time_frame>First 63 days</time_frame>
    <description>Calculate the amount of ASN004 in the bloodstream</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Calculate the maximum plasma concentration at steady state</measure>
    <time_frame>First 63 days</time_frame>
    <description>Calculate the maximum amount of ASN004 in the bloodstream</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Calculate the terminal elimination rate of ASN004</measure>
    <time_frame>First 63 days</time_frame>
    <description>Calculate how fast ASN004 leaves the body</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the size of measurable tumor lesions</measure>
    <time_frame>up to 1 year</time_frame>
    <description>Change from baseline in the sum of the longest dimension in millimeters or each measurable lesion</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the status of non-measurable tumor lesions</measure>
    <time_frame>Up to 1 year</time_frame>
    <description>Number of subjects that have resolution on non-measurable tumor lesions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Appearance of new tumor lesions</measure>
    <time_frame>Up to 1 year</time_frame>
    <description>Number of subjects with new lesions</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Correlate 5T4 oncofetal protein (5T4) expression and clinical efficacy</measure>
    <time_frame>Up to 1 year</time_frame>
    <description>Number of patients with 5T4 expression that have a complete response, partial response or prolonged stable disease when receiving ASN004.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">43</enrollment>
  <condition>Solid Tumor</condition>
  <arm_group>
    <arm_group_label>ASN004 ascending doses</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive escalating doses of ASN004 to identify the best dose for further study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ASN004</intervention_name>
    <description>ASN004 is an antibody-drug conjugate for the treatment of advanced or metastatic solid tumors.</description>
    <arm_group_label>ASN004 ascending doses</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          1. Provide written, voluntary informed consent prior to any -study specific procedure.&#xD;
&#xD;
          2. Histologically confirmed diagnosis of advanced malignant solid tumor.&#xD;
&#xD;
          3. All patients must agree to provide fresh or archival tumor tissue from the tumor&#xD;
             lesion that has not been previously irradiated. Patients without archival tissue may&#xD;
             only be enrolled if the patient consents to a screening biopsy and this procedure may&#xD;
             be safely performed in the judgment of the Investigator.&#xD;
&#xD;
          4. For Dose Expansion patients, eligible tumor histologies will be limited to those&#xD;
             malignancies known to have highest expression of 5T4 including colorectal, breast,&#xD;
             ovarian, lung, liver, and renal carcinomas. A maximum of 3 prior cytotoxic&#xD;
             chemotherapy regimens is permitted for advanced disease.&#xD;
&#xD;
          5. Failure of standard therapy or no standard therapy available.&#xD;
&#xD;
          6. Presence of at least 1 measurable target lesion by Response Evaluation Criteria in&#xD;
             Solid Tumors (RECIST) 1.1 excluding previously irradiated lesions, bone metastasis, or&#xD;
             pleural effusion as sole manifestations of disease. Dose escalation patients with&#xD;
             evaluable (non-measurable) disease may be permitted to enroll with Medical Monitor&#xD;
             approval.&#xD;
&#xD;
          7. Age of at least 18 years old.&#xD;
&#xD;
          8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.&#xD;
&#xD;
          9. A male patient must agree to use contraception as detailed in this protocol during the&#xD;
             treatment period and for at least 3 months after the last dose of study treatment and&#xD;
             refrain from donating sperm during this period.&#xD;
&#xD;
         10. A female patient is eligible to participate if she is not pregnant, not breastfeeding,&#xD;
             and at least 1 of the following conditions applies.&#xD;
&#xD;
             i. Not a woman of childbearing potential (WOCBP) OR ii. A WOCBP who agrees to follow&#xD;
             the contraceptive guidance during the treatment period and for at least 3 months after&#xD;
             the last dose of study treatment.&#xD;
&#xD;
         11. Adequate organ function.&#xD;
&#xD;
         12. Patient is willing and able to comply with all protocol required visits and&#xD;
             assessments.&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          1. Hematologic malignancies and lymphomas.&#xD;
&#xD;
          2. Patients with known brain metastases unless the patient has a single lesion or&#xD;
             multiple lesions whose sum of the longest diameter is ≤ 1 cm AND who are asymptomatic.&#xD;
&#xD;
          3. Serious concurrent medical conditions.&#xD;
&#xD;
          4. Patients with known history of left ventricular ejection fraction of &lt; 50%.&#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_official>
    <last_name>Alison L Hannah, MD</last_name>
    <role>Study Director</role>
    <affiliation>Kirilys Therapeutics Inc.</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Study Manager</last_name>
    <phone>James Chrisman</phone>
    <email>jchrisman@kirilys.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Alison L Hannah, MD</last_name>
    <email>ahannah@kirilys.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Emory University - Winship Cancer Institute</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Manali A Bhave, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>NEXT Austin</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78758</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Andrae Vandross, MD</last_name>
      <phone>737-610-5200</phone>
    </contact>
    <investigator>
      <last_name>Andrae Vandross</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>NEXT Oncology</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78240</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Anthony Tolcher, M.D</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Next Virginia</name>
      <address>
        <city>Fairfax</city>
        <state>Virginia</state>
        <zip>22031</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Alex Spira, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>May 27, 2020</study_first_submitted>
  <study_first_submitted_qc>May 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 1, 2020</study_first_posted>
  <last_update_submitted>April 17, 2023</last_update_submitted>
  <last_update_submitted_qc>April 17, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 19, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>antibody-drug conjugate</keyword>
  <keyword>immunoconjugate</keyword>
  <keyword>General Solid Tumors</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT04410224
org study id: ASN004-101
nct id: NCT04410224
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
Participants in this study will receive ASN004 once every 3 weeks by intravenous infusion.
      The study will test various doses of ASN004 to find out the highest safe dose to test in
      future trials.

      Eligible subjects will be sequentially enrolled in cohorts at escalated doses.
Eligible patients will be sequentially enrolled sequentially at escalating doses.

      Dose escalation decisions will be based on the review of clinical safety and pharmacokinetic
      (PD) and pharmacodynamics (PD) data and agreed upon by the Sponsor and investigators.

      The maximum tolerated dose (MTD) will have an estimated DLT rate of < 33%. Cohorts may be
      expanded at any dose level or at the MTD for further evaluation of safety, or PK parameters
      as required.
allocation: N/A
intervention model: Sequential Assignment
intervention model description: Escalating doses of ASN004
primary purpose: Treatment
masking: None (Open Label)
measure: Determine the maximum tolerated dose of ASN004
time frame: first 21 days
description: The MTD will be determined by evaluating the number of subjects with treatment related adverse events (AEs) and DLTs.
measure: Calculate the pharmacokinetic (PK) area under the plasma concentration of ASN004
time frame: First 63 days
description: Calculate the amount of ASN004 in the bloodstream
measure: Calculate the maximum plasma concentration at steady state
time frame: First 63 days
description: Calculate the maximum amount of ASN004 in the bloodstream
measure: Calculate the terminal elimination rate of ASN004
time frame: First 63 days
description: Calculate how fast ASN004 leaves the body
measure: Change in the size of measurable tumor lesions
time frame: up to 1 year
description: Change from baseline in the sum of the longest dimension in millimeters or each measurable lesion
measure: Change in the status of non-measurable tumor lesions
time frame: Up to 1 year
description: Number of subjects that have resolution on non-measurable tumor lesions
measure: Appearance of new tumor lesions
time frame: Up to 1 year
description: Number of subjects with new lesions
measure: Correlate 5T4 oncofetal protein (5T4) expression and clinical efficacy
time frame: Up to 1 year
description: Number of patients with 5T4 expression that have a complete response, partial response or prolonged stable disease when receiving ASN004.
arm group label: ASN004 ascending doses
arm group type: Experimental
description: Patients will receive escalating doses of ASN004 to identify the best dose for further study.
intervention type: Drug
intervention name: ASN004
description: ASN004 is an antibody-drug conjugate for the treatment of advanced or metastatic solid tumors.
arm group label: ASN004 ascending doses
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Alison L Hannah, MD
role: Study Director
affiliation: Kirilys Therapeutics Inc.
last name: Study Manager
phone: James Chrisman
email: jchrisman@kirilys.com
last name: Alison L Hannah, MD
email: ahannah@kirilys.com
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Neoplasms
sharing ipd: No