<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/NCT03292783</url>
  </required_header>
  <id_info>
    <org_study_id>NOV150101-101</org_study_id>
    <nct_id>NCT03292783</nct_id>
  </id_info>
  <brief_title>This is a Study to Evaluate the Safety and Tolerability of the Study Drug ABL001, and to Determine the Maximum Tolerated Dose and/or Recommended Phase 2 Study Dose of ABL001</brief_title>
  <official_title>An Open-label, Dose-escalation and Expansion Phase 1/2a Clinical Trial to Assess the Tolerability, Safety, Pharmacokinetics, Pharmacodynamics and the Anti-tumor Efficacy of NOV1501 (ABL001) in Patients With Advanced Solid Tumors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>ABL Bio, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National OncoVenture</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>ABL Bio, Inc.</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>
      The purpose of this open-label, dose escalation-dose expansion, Phase 1 clinical trial is to&#xD;
      evaluate the safety, pharmacokinetics and anti-tumor activity and determine the maximum&#xD;
      tolerated dose (MTD) and recommended phase II dose (RP2D) of NOV1501 (ABL001).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an open-label, Phase 1 dose escalation and expansion study of NOV1501 (ABL001) to&#xD;
      evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and the anti-tumor&#xD;
      efficacy of ABL001 in patients with advanced solid tumors after failure of standard of care.&#xD;
&#xD;
      Patients will be enrolled in two stages: a dose-escalation stage and an expansion phase. DLTs&#xD;
      will be assessed as the primary endpoint in this trial.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 18, 2017</start_date>
  <completion_date type="Actual">March 2, 2021</completion_date>
  <primary_completion_date type="Actual">March 2, 2021</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>Number and percentage of subjects with adverse events (AEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs)</measure>
    <time_frame>From time of 1st administration of ABL001 until day 21.</time_frame>
    <description>The maximum tolerated dose/maximum administered dose will be determined by the number of participant experiencing DLTs. The safety profile will be assessed through number of participants experiencing AEs, SAEs, abnormal laboratory parameters, vital signs and electrocardiogram (ECG) results.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">45</enrollment>
  <condition>Advanced Solid Tumors</condition>
  <arm_group>
    <arm_group_label>NOV150101 (ABL001)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>NOV1501 (ABL001)</intervention_name>
    <description>VEGF/DLL4 targeting bispecific antibody</description>
    <arm_group_label>NOV150101 (ABL001)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ≥19 year old patients with histologically or cytologically confirmed metastatic or&#xD;
             unresectable advanced solid tumors&#xD;
&#xD;
          -  Lesions measured by tumor markers or by CT/MRI must be evaluable based on response&#xD;
             evaluation criteria in solid tumors (RECIST) version 1.1.&#xD;
&#xD;
          -  Life expectancy ≥12 weeks&#xD;
&#xD;
          -  ECOG performance status ≤2&#xD;
&#xD;
          -  Women of childbearing potential must have a negative pregnancy test outcome&#xD;
&#xD;
          -  Patients must provide written informed consent to voluntary participation in this&#xD;
             study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of hypersensitivity reactions to any of the components of the investigational&#xD;
             product or other drugs of the same class&#xD;
&#xD;
          -  Less than 4 weeks have elapsed since a major surgery and 2 weeks have elapsed since a&#xD;
             minor surgery&#xD;
&#xD;
          -  New York Heart Association (NYHA) class ≥II congestive heart failure (CHF)&#xD;
&#xD;
          -  Persistent, clinically significant NCI-CTCAE v4.03 Grade ≥2 toxicities from the&#xD;
             previous anticancer therapy&#xD;
&#xD;
          -  Severe infections or severe traumatic systemic disorders&#xD;
&#xD;
          -  Symptomatic or uncontrolled central nervous system (CNS) metastasis&#xD;
&#xD;
          -  Pregnant or lactating women or patients planning to become pregnant during the study&#xD;
&#xD;
          -  Participation in another clinical trial within 30 days prior to screening&#xD;
&#xD;
          -  Administration of antiplatelets or anticoagulants within 2 weeks prior to screening&#xD;
&#xD;
          -  Requiring continuous treatment with systemic NSAIDs or systemic corticosteroids&#xD;
&#xD;
          -  HIV or other severe diseases that warrant the exclusion from this study&#xD;
&#xD;
          -  Peritoneal and/or pleural fluid drainage within 28 days prior to screening&#xD;
&#xD;
          -  History of hemoptysis within 28 days prior to screening&#xD;
&#xD;
          -  Serious, untreated scar, active ulcer, or untreated fracture&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Seoul National University Bundang Hospital</name>
      <address>
        <city>Seongnam-si</city>
        <zip>13620</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Samsung Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>135-710</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>September 21, 2017</study_first_submitted>
  <study_first_submitted_qc>September 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 26, 2017</study_first_posted>
  <last_update_submitted>July 4, 2021</last_update_submitted>
  <last_update_submitted_qc>July 4, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 7, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>VEGF</keyword>
  <keyword>DLL4</keyword>
  <keyword>Solid Tumors</keyword>
  <keyword>bispecific antibody</keyword>
  <keyword>anti-angiogenic</keyword>
  <!-- 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/NCT03292783
org study id: NOV150101-101
nct id: NCT03292783
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this open-label, dose escalation-dose expansion, Phase 1 clinical trial is to
      evaluate the safety, pharmacokinetics and anti-tumor activity and determine the maximum
      tolerated dose (MTD) and recommended phase II dose (RP2D) of NOV1501 (ABL001).
This is an open-label, Phase 1 dose escalation and expansion study of NOV1501 (ABL001) to
      evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and the anti-tumor
      efficacy of ABL001 in patients with advanced solid tumors after failure of standard of care.

      Patients will be enrolled in two stages: a dose-escalation stage and an expansion phase. DLTs
      will be assessed as the primary endpoint in this trial.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number and percentage of subjects with adverse events (AEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs)
time frame: From time of 1st administration of ABL001 until day 21.
description: The maximum tolerated dose/maximum administered dose will be determined by the number of participant experiencing DLTs. The safety profile will be assessed through number of participants experiencing AEs, SAEs, abnormal laboratory parameters, vital signs and electrocardiogram (ECG) results.
arm group label: NOV150101 (ABL001)
arm group type: Experimental
intervention type: Drug
intervention name: NOV1501 (ABL001)
description: VEGF/DLL4 targeting bispecific antibody
arm group label: NOV150101 (ABL001)
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
country: Korea, Republic of
responsible party type: Sponsor