<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/NCT02235688</url>
  </required_header>
  <id_info>
    <org_study_id>ALDOXORUBICIN-P1-MTD-03</org_study_id>
    <nct_id>NCT02235688</nct_id>
  </id_info>
  <brief_title>Study to Investigate the Safety and Activity of Aldoxorubicin Plus Gemcitabine in Subjects With Metastatic Solid Tumors</brief_title>
  <official_title>An Open-Label Phase 1b Study to Investigate the Preliminary Safety and Activity of Aldoxorubicin Plus Gemcitabine in Subjects With Metastatic Solid Tumors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>ImmunityBio, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>ImmunityBio, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a Phase 1 study to investigate the safety and activity of aldoxorubicin plus&#xD;
      gemcitabine in Subjects with solid tumors.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      An open-label Phase 1b study to investigate the preliminary safety and activity of&#xD;
      aldoxorubicin plus gemcitabine in subjects with metastatic solid tumors administered at doses&#xD;
      of 170, 250 or 350 mg/m2 by intravenous infusion (IVI) on Day 1 every 21 days plus 900 mg/m2&#xD;
      gemcitabine on Days 1 and 8 every 21 days.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">January 2017</completion_date>
  <primary_completion_date type="Actual">January 2017</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Safety Measures</measure>
    <time_frame>14 months</time_frame>
    <description>The primary objective of this study is to determine the preliminary safety of administration of aldoxorubicin in combination with gemcitabine in subjects with metastatic solid tumors as measured by the frequency and severity of adverse events (AEs), abnormal findings on physical examination, laboratory tests, vital signs, echocardiograms (ECHO) or multiple-gated acquisition (MUGA) scans, electrocardiogram (ECG) results, and weight.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Tumor Response</measure>
    <time_frame>17 months</time_frame>
    <description>The secondary objective of this study is to evaluate the activity of aldoxorubicin in combination with gemcitabine in this population, assessed by overall response rate (ORR) and progression-free survival (PFS).</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Metastatic Solid Tumors</condition>
  <arm_group>
    <arm_group_label>aldoxorubicin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>aldoxorubicin</intervention_name>
    <description>administered at 170 mg/m2 by intravenous infusion (IVI) on Day 1 every 21 days plus 900 mg/m2 gemcitabine on Days 1 and 8 every 21 days.</description>
    <arm_group_label>aldoxorubicin</arm_group_label>
    <other_name>INNO-206</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>aldoxorubicin</intervention_name>
    <description>administered at 250 mg/m2 by intravenous infusion (IVI) on Day 1 every 21 days plus 900 mg/m2 gemcitabine on Days 1 and 8 every 21 days.</description>
    <arm_group_label>aldoxorubicin</arm_group_label>
    <other_name>INNO-206</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>aldoxorubicin</intervention_name>
    <description>administered at 350 mg/m2 by intravenous infusion (IVI) on Day 1 every 21 days plus 900 mg/m2 gemcitabine on Days 1 and 8 every 21 days.</description>
    <arm_group_label>aldoxorubicin</arm_group_label>
    <other_name>INNO-206</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>gemcitabine</intervention_name>
    <arm_group_label>aldoxorubicin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age between 15-80 years, male or female.&#xD;
&#xD;
          2. Advanced, unresectable, metastatic solid tumor that has either relapsed or was&#xD;
             refractory to treatment with at least 1 prior chemotherapy or immunotherapy regimen&#xD;
             and for which no standard approved therapy exists.&#xD;
&#xD;
          3. Progressive disease (PD) &lt; 6 months prior to enrollment.&#xD;
&#xD;
          4. Capable of providing informed consent and complying with trial procedures.&#xD;
&#xD;
          5. ECOG PS 0-2 (Appendix B).&#xD;
&#xD;
          6. Life expectancy &gt;12 weeks.&#xD;
&#xD;
          7. Measurable tumor lesions according to RECIST 1.1 criteria.&#xD;
&#xD;
          8. Women must not be able to become pregnant (eg post-menopausal for at least 1 year,&#xD;
             surgically sterile, or practicing adequate birth control methods) for the duration of&#xD;
             the study. (Adequate contraception includes: oral contraception, implanted&#xD;
             contraception, intrauterine device implanted for at least 3 months, or barrier method&#xD;
             in conjunction with spermicide.)&#xD;
&#xD;
          9. Males and their female partner(s) of child-bearing potential must use 2 forms of&#xD;
             effective contraception (see Inclusion 8 plus condom or vasectomy for males) from the&#xD;
             last menstrual period of the female partner during the study treatment and for 6&#xD;
             months after the final dose of study treatment.&#xD;
&#xD;
         10. Women of child bearing potential must have a negative serum or urine pregnancy test at&#xD;
             the Screening Visit and be non-lactating.&#xD;
&#xD;
         11. Geographic accessibility to the site that ensures the subject will be able to keep all&#xD;
             study-related appointments.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Prior exposure to &gt;5 cycles or 375 mg/m2 of either doxorubicin or Doxil®.&#xD;
&#xD;
          2. Chemotherapy, palliative surgery and/or radiation treatment less than 30 days prior to&#xD;
             enrollment.&#xD;
&#xD;
          3. Exposure to any investigational agent within 30 days of enrollment.&#xD;
&#xD;
          4. CNS metastases that are symptomatic.&#xD;
&#xD;
          5. History of other malignancies except cured basal cell carcinoma, superficial bladder&#xD;
             cancer or carcinoma in situ of the cervix unless documented free of cancer for ≥5&#xD;
             years.&#xD;
&#xD;
          6. Laboratory values: Screening serum creatinine &gt;1.5×ULN, ALT &gt;3×ULN, or &gt;5×ULN if liver&#xD;
             metastases are present, total bilirubin &gt;3×ULN, ANC &lt;1,500/mm3, platelet concentration&#xD;
             &lt;100,000/mm3, hematocrit level &lt;25% for females or &lt;27% for males, coagulation tests&#xD;
             (PT, PTT, INR) &gt;1.5×ULN, and albumin &lt;2.0 g/dL.&#xD;
&#xD;
          7. Clinically evident CHF &gt; class II of the NYHA guidelines (Appendix D).&#xD;
&#xD;
          8. Current serious, clinically significant cardiac arrhythmias, defined as the existence&#xD;
             of an absolute arrhythmia or ventricular arrhythmias classified as Lown III, IV or V&#xD;
             (Appendix F).&#xD;
&#xD;
          9. Baseline QTc &gt;470 msec and/or previous history of QT prolongation while taking other&#xD;
             medications. Concomitant use of medications associated with a high incidence of QT&#xD;
             prolongation is not allowed (Appendix G).&#xD;
&#xD;
         10. History or signs of active coronary artery disease with or without angina pectoris.&#xD;
&#xD;
         11. Serious myocardial dysfunction defined scintigraphically (eg MUGA, myocardial&#xD;
             scintigram) or ultrasound determined absolute LVEF &lt;45% of predicted.&#xD;
&#xD;
         12. History of HIV infection.&#xD;
&#xD;
         13. Active, clinically significant serious infection requiring treatment with antibiotics,&#xD;
             anti-virals or anti-fungals.&#xD;
&#xD;
         14. Major surgery within 21 days prior to enrollment.&#xD;
&#xD;
         15. Substance abuse or any condition that might interfere with the subject's participation&#xD;
             in the study or in the evaluation of the study results.&#xD;
&#xD;
         16. Any condition that is unstable and could jeopardize the subject's participation in the&#xD;
             study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dan Levitt, M.D.</last_name>
    <role>Study Director</role>
    <affiliation>CytRx Coporation</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Virginia G. Piper Cancer Center</name>
      <address>
        <city>Scottsdale</city>
        <state>Arizona</state>
        <zip>85258</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sarcoma Oncology Center</name>
      <address>
        <city>Santa Monica</city>
        <state>California</state>
        <zip>90403</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2017</verification_date>
  <study_first_submitted>August 15, 2014</study_first_submitted>
  <study_first_submitted_qc>September 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 10, 2014</study_first_posted>
  <last_update_submitted>January 27, 2022</last_update_submitted>
  <last_update_submitted_qc>January 27, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 10, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>aldoxorubicin</keyword>
  <keyword>INNO-206</keyword>
  <keyword>solid tumors</keyword>
  <keyword>gemcitabine</keyword>
  <keyword>phase 1</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gemcitabine</mesh_term>
    <mesh_term>Doxorubicin</mesh_term>
  </intervention_browse>
  <!-- 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/NCT02235688
org study id: ALDOXORUBICIN-P1-MTD-03
nct id: NCT02235688
lead sponsor: 
has dmc: No
This is a Phase 1 study to investigate the safety and activity of aldoxorubicin plus
      gemcitabine in Subjects with solid tumors.
An open-label Phase 1b study to investigate the preliminary safety and activity of
      aldoxorubicin plus gemcitabine in subjects with metastatic solid tumors administered at doses
      of 170, 250 or 350 mg/m2 by intravenous infusion (IVI) on Day 1 every 21 days plus 900 mg/m2
      gemcitabine on Days 1 and 8 every 21 days.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Safety Measures
time frame: 14 months
description: The primary objective of this study is to determine the preliminary safety of administration of aldoxorubicin in combination with gemcitabine in subjects with metastatic solid tumors as measured by the frequency and severity of adverse events (AEs), abnormal findings on physical examination, laboratory tests, vital signs, echocardiograms (ECHO) or multiple-gated acquisition (MUGA) scans, electrocardiogram (ECG) results, and weight.
measure: Tumor Response
time frame: 17 months
description: The secondary objective of this study is to evaluate the activity of aldoxorubicin in combination with gemcitabine in this population, assessed by overall response rate (ORR) and progression-free survival (PFS).
arm group label: aldoxorubicin
arm group type: Experimental
intervention type: Drug
intervention name: aldoxorubicin
description: administered at 170 mg/m2 by intravenous infusion (IVI) on Day 1 every 21 days plus 900 mg/m2 gemcitabine on Days 1 and 8 every 21 days.
arm group label: aldoxorubicin
other name: INNO-206
intervention type: Drug
intervention name: aldoxorubicin
description: administered at 250 mg/m2 by intravenous infusion (IVI) on Day 1 every 21 days plus 900 mg/m2 gemcitabine on Days 1 and 8 every 21 days.
arm group label: aldoxorubicin
other name: INNO-206
intervention type: Drug
intervention name: aldoxorubicin
description: administered at 350 mg/m2 by intravenous infusion (IVI) on Day 1 every 21 days plus 900 mg/m2 gemcitabine on Days 1 and 8 every 21 days.
arm group label: aldoxorubicin
other name: INNO-206
intervention type: Drug
intervention name: gemcitabine
arm group label: aldoxorubicin
criteria: 
gender: All
minimum age: 15 Years
maximum age: 80 Years
healthy volunteers: No
last name: Dan Levitt, M.D.
role: Study Director
affiliation: CytRx Coporation
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Neoplasms
mesh term: Gemcitabine
mesh term: Doxorubicin