<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/NCT04403308</url>
  </required_header>
  <id_info>
    <org_study_id>ONO-7913-01</org_study_id>
    <nct_id>NCT04403308</nct_id>
  </id_info>
  <brief_title>ONO-7913 Phase I Study (ONO-7913)</brief_title>
  <official_title>An Open-label, Uncontrolled, Dose Escalation Study in Patients With Advanced or Metastatic Solid Cancers (ONO-7913-01)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ono Pharmaceutical Co. Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ono Pharmaceutical Co. Ltd</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To assess the tolerability, safety, and pharmacokinetics (PK) of ONO-7913 in patients with&#xD;
      advanced or metastatic solid cancers and explore its efficacy and biomarkers.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 28, 2020</start_date>
  <completion_date type="Actual">January 13, 2022</completion_date>
  <primary_completion_date type="Actual">January 13, 2022</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>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Dose-limiting toxicities</measure>
    <time_frame>28 days</time_frame>
    <description>Number of participants with a DLT</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Adverse events</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>Assessed by the NCI CTCAE v5.0 criteria</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Concentration vs time of ONO-7913 as single dose</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>PK profile</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">7</enrollment>
  <condition>Solid Tumor</condition>
  <arm_group>
    <arm_group_label>ONO-7913 as a Single Agent</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>ONO-7913</intervention_name>
    <description>ONO-7913 will be administered by intravenous continuous infusion during the designated time.</description>
    <arm_group_label>ONO-7913 as a Single Agent</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients with histologically or cytologically confirmed advanced or metastatic solid&#xD;
             tumors&#xD;
&#xD;
          2. ECOG Performance Status of 0-1&#xD;
&#xD;
          3. Patients with life expectancy of at least 3 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with multiple cancers&#xD;
&#xD;
          2. Patients with history of serious allergy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kazuhiro Nakabayashi</last_name>
    <role>Study Chair</role>
    <affiliation>Ono Pharmaceutical Co. Ltd</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Chuo-ku</city>
        <state>Tokyo</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>May 21, 2020</study_first_submitted>
  <study_first_submitted_qc>May 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 27, 2020</study_first_posted>
  <last_update_submitted>August 1, 2022</last_update_submitted>
  <last_update_submitted_qc>August 1, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 2, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_url>https://www.ono.co.jp/eng/rd/policy.html</ipd_url>
  </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/NCT04403308
org study id: ONO-7913-01
nct id: NCT04403308
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To assess the tolerability, safety, and pharmacokinetics (PK) of ONO-7913 in patients with
      advanced or metastatic solid cancers and explore its efficacy and biomarkers.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Dose-limiting toxicities
time frame: 28 days
description: Number of participants with a DLT
measure: Adverse events
time frame: Up to 24 months
description: Assessed by the NCI CTCAE v5.0 criteria
measure: Concentration vs time of ONO-7913 as single dose
time frame: Up to 24 months
description: PK profile
arm group label: ONO-7913 as a Single Agent
arm group type: Experimental
intervention type: Biological
intervention name: ONO-7913
description: ONO-7913 will be administered by intravenous continuous infusion during the designated time.
arm group label: ONO-7913 as a Single Agent
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Kazuhiro Nakabayashi
role: Study Chair
affiliation: Ono Pharmaceutical Co. Ltd
facility: 
country: Japan
responsible party type: Sponsor
sharing ipd: Yes
ipd url: https://www.ono.co.jp/eng/rd/policy.html