<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/NCT04419623</url>
  </required_header>
  <id_info>
    <org_study_id>TL-895-202</org_study_id>
    <nct_id>NCT04419623</nct_id>
  </id_info>
  <brief_title>A Study of TL-895 With Standard Available Treatment Versus Standard Available Treatment for the Treatment of COVID-19 in Patients With Cancer</brief_title>
  <official_title>A Phase 1/2, Double-Blind, Randomized, Placebo-Controlled Study of TL-895 With Standard Available Treatment Versus Standard Available Treatment for the Treatment of COVID-19 in Patients With Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Telios Pharma, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Telios Pharma, Inc.</source>
  <oversight_info>
    <has_dmc>Yes</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>
      This study evaluates TL-895, a tyrosine kinase inhibitor (TKI). This is a study comprising a&#xD;
      Phase 1 safety assessment. TL-895 open-label will be administered orally at an assigned dose&#xD;
      continuously in 7-day cycles for 2 cycles. Up to 3 dose levels will be evaluated.&#xD;
&#xD;
      Only Phase 1 of the study was enrolled and the study did not proceed into Phase 2.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 9, 2020</start_date>
  <completion_date type="Actual">December 15, 2020</completion_date>
  <primary_completion_date type="Actual">September 22, 2020</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>
    <intervention_model_description>Up to 18 subjects will participate in a dose-finding safety lead-in to determine the recommended TL-895 dose.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Recommended dose of TL-895</measure>
    <time_frame>After the day 14 of the 6th subject per dose level</time_frame>
    <description>To determine the recommended dose of TL-895 to be based on the observed dose limiting toxicity</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">7</enrollment>
  <condition>COVID-19</condition>
  <condition>Sars-CoV2</condition>
  <condition>Cancer</condition>
  <condition>Solid Tumor</condition>
  <condition>Carcinoma</condition>
  <condition>Blood Cancer</condition>
  <arm_group>
    <arm_group_label>Dose Finding - 200mg BID</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>200mg TL-895 orally BID taken continuously in 7-day cycles for 2 - 4 cycles with SAT for COVID-19 (14 - 28 days of treatment).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>TL-895</intervention_name>
    <description>TL-895, administered by mouth</description>
    <arm_group_label>Dose Finding - 200mg BID</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Known diagnosis of active cancer that is not considered cured or disease free.&#xD;
&#xD;
          -  Confirmed COVID-19 infection as per World Health Organization (WHO) criteria with&#xD;
             suspected pneumonia requiring hospitalization and oxygen saturation &lt; 94% on room air&#xD;
             or requires supplemental oxygen.&#xD;
&#xD;
          -  Adequate hematological, hepatic and renal function as would be medically expected of a&#xD;
             cancer patient population.&#xD;
&#xD;
          -  Able to swallow and absorb oral medications.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current active treatment with medications contraindicated for receipt of&#xD;
             investigational product.&#xD;
&#xD;
          -  Require chemotherapy or urgent systemic therapy for active cancer that cannot be&#xD;
             withheld.&#xD;
&#xD;
          -  No remaining available therapies for advanced or metastatic malignancies.&#xD;
&#xD;
          -  Participation in another clinical study with therapeutic intent for COVID-19&#xD;
&#xD;
          -  Require artificial ventilation at screening.&#xD;
&#xD;
          -  Life expectancy less than 6 months.&#xD;
&#xD;
          -  Medical conditions that make it unsafe to receive investigational product (for&#xD;
             example, heart attack in the last 6 mos, unstable angina, uncontrolled arrhythmia,&#xD;
             heart failure class 3/4, QTC interval &gt; 480 msec; known bleeding disorders, stroke or&#xD;
             intracranial hemorrhage in the last 6 mos; active HBV, HCV or history of HIV; GI&#xD;
             malabsorption syndrome, small bowel resection, poorly controlled IBS;&#xD;
             untreated/actively progressing known CNS lesions).&#xD;
&#xD;
          -  Receipt of radiation therapy to the lung or mediastinum for treatment of COVID-19&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Georgia Cancer Center</name>
      <address>
        <city>Augusta</city>
        <state>Georgia</state>
        <zip>30912</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Ohio State Comprehensive Cancer Center</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>June 3, 2020</study_first_submitted>
  <study_first_submitted_qc>June 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 5, 2020</study_first_posted>
  <last_update_submitted>May 10, 2021</last_update_submitted>
  <last_update_submitted_qc>May 10, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 12, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>TKI</keyword>
  <keyword>Tyrosine Kinase Inhibitor</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Hematologic 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/NCT04419623
org study id: TL-895-202
nct id: NCT04419623
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This study evaluates TL-895, a tyrosine kinase inhibitor (TKI). This is a study comprising a
      Phase 1 safety assessment. TL-895 open-label will be administered orally at an assigned dose
      continuously in 7-day cycles for 2 cycles. Up to 3 dose levels will be evaluated.

      Only Phase 1 of the study was enrolled and the study did not proceed into Phase 2.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Up to 18 subjects will participate in a dose-finding safety lead-in to determine the recommended TL-895 dose.
primary purpose: Treatment
masking: None (Open Label)
measure: Recommended dose of TL-895
time frame: After the day 14 of the 6th subject per dose level
description: To determine the recommended dose of TL-895 to be based on the observed dose limiting toxicity
arm group label: Dose Finding - 200mg BID
arm group type: Experimental
description: 200mg TL-895 orally BID taken continuously in 7-day cycles for 2 - 4 cycles with SAT for COVID-19 (14 - 28 days of treatment).
intervention type: Drug
intervention name: TL-895
description: TL-895, administered by mouth
arm group label: Dose Finding - 200mg BID
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Hematologic Neoplasms
sharing ipd: No