<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/NCT01673438</url>
  </required_header>
  <id_info>
    <org_study_id>ALDOXORUBICIN-P1-MTD-02</org_study_id>
    <nct_id>NCT01673438</nct_id>
  </id_info>
  <brief_title>Phase 1b Study to Investigate the Safety and Maximum Tolerated Dose of Aldoxorubicin (INNO-206) Plus Doxorubicin HCL in Subjects With Advanced Solid Tumors</brief_title>
  <official_title>An Open-Label Phase 1b Study to Investigate the Safety and Maximum Tolerated Dose of Aldoxorubicin (INNO-206) Plus Doxorubicin HCL Administered as Infusions Every 3 Weeks in Subjects With Advanced 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 1b open-label study to investigate the safety and maximum tolerated dose of&#xD;
      aldoxorubicin plus doxorubicin HCl adminstered as infusion every 3 weeks for up to 8 cycles&#xD;
      in subjects with advance solid tumors.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      An Open-Label Phase 1b Study to Investigate the Safety and Maximum Tolerated Dose of&#xD;
      Aldoxorubicin (INNO-206) Plus Doxorubicin HCl Administered as Infusions Every 3 Weeks in&#xD;
      Subjects with Advanced Solid Tumors&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2012</start_date>
  <completion_date type="Actual">April 2014</completion_date>
  <primary_completion_date type="Actual">April 2014</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>Safety and Tolerability</measure>
    <time_frame>up to 6 months</time_frame>
    <description>The primary objective of this study is to determine the preliminary safety and maximum tolerated dose (MTD) of aldoxorubicin plus doxorubicin HCl in subjects with advanced solid tumors who have failed standard therapies.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Tumor Response</measure>
    <time_frame>up to 6 months</time_frame>
    <description>The secondary objective of this study is to evaluate the tumor response to aldoxorubicin plus doxorubicin HCl in this population assessed by radiographic means using the RECIST 1.1 criteria.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Advanced Solid Tumor</condition>
  <arm_group>
    <arm_group_label>Aldoxorubicin plus doxorubicin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Aldoxorubicin dosages of 175, 240, and 320 (doxorubicin equivalents of 130, 180, and 240 mg/m2) will be administered as a 30 minutes IVI on Day 1 of each cycle. In addition 35 mg/m2 of doxorubicin HCl will be administered as an IVI over &gt; 3 minutes no later than 3 hours, but no more than 6 hours before the start of aldoxorubicin infusion.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>aldoxorubicin</intervention_name>
    <arm_group_label>Aldoxorubicin plus doxorubicin</arm_group_label>
    <other_name>INNO-206</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age ≥ 18 years, male or female.&#xD;
&#xD;
          2. Histologically or cytologically confirmed malignant solid tumor that has relapsed or&#xD;
             is refractory to standard therapy or no standard chemotherapy exists.&#xD;
&#xD;
          3. Capable of providing informed consent and complying with trial procedures.&#xD;
&#xD;
          4. Baseline absolute left ventricular ejection fraction (LVEF) measured scintigraphically&#xD;
             (MUGA, myocardial scintigram) or by ultrasound (echocardiogram) ≥ Institutional Lower&#xD;
             Limit of Normal.&#xD;
&#xD;
          5. Eastern Cooperative Oncology Group performance status (ECOG PS) 0-2.&#xD;
&#xD;
          6. Life expectancy &gt; 12 weeks.&#xD;
&#xD;
          7. Measurable or evaluable disease according to RECIST 1.1 criteria.15&#xD;
&#xD;
          8. Women must not be able to become pregnant (e.g., 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. 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;
         10. Geographic accessibility to the site that ensures that the subject will be able to&#xD;
             keep all study-related appointments.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Palliative surgery, chemotherapy, immunotherapy and/or radiation treatment &lt; 4 weeks&#xD;
             prior to the Screening Visit.&#xD;
&#xD;
          2. Prior treatment with ≥ 150 mg/m2 doxorubicin HCl or Doxil® cumulative dose, or&#xD;
             epirubicin ≥ 150 mg/m2.&#xD;
&#xD;
          3. Exposure to any investigational agent within 30 days of Randomization.&#xD;
&#xD;
          4. Evidence of active or uncontrolled central nervous system (CNS) metastasis (negative&#xD;
             imaging study performed due to suspicion of CNS metastasis within 4 weeks of Screening&#xD;
             Visit).&#xD;
&#xD;
          5. History of other malignancies except cured basal cell carcinoma, squamous cell&#xD;
             carcinoma, superficial bladder cancer or carcinoma in situ of the cervix.&#xD;
&#xD;
          6. Laboratory values: Screening serum creatinine ≥ 2 times the upper limit of normal&#xD;
             (ULN), alanine aminotransferase (ALT) or aspartate aminotransferase (AST) &gt; 2 times&#xD;
             the ULN if no liver metastases or 5 times the ULN if liver metastases, total bilirubin&#xD;
             &gt; 2 times the ULN, white blood cell (WBC) count &lt; 3500/mm3, or absolute neutrophil&#xD;
             count (ANC) &lt; 1500/mm3, platelet concentration &lt; 100,000/mm3, hematocrit level &lt; 25%&#xD;
             for females or &lt; 27% for males, or coagulation tests (prothrombin time [PT]; partial&#xD;
             thromboplastin time [PTT]), International Normalized Ration (INR) &gt; 1.5 times the ULN,&#xD;
             serum albumin &lt; 2.0g/dL.&#xD;
&#xD;
          7. Clinically evident congestive heart failure (CHF) &gt; class II of the New York Heart&#xD;
             Association (NYHA) guidelines.&#xD;
&#xD;
          8. 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 QTc&#xD;
             prolongation is not allowed.&#xD;
&#xD;
          9. Serious clinically significant cardiac arrhythmias, defined as the existence of an&#xD;
             absolute arrhythmia or ventricular arrhythmias classified as Lown III, IV or V.&#xD;
&#xD;
         10. History or signs of active coronary artery disease with or without angina pectoris.&#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>Dan Levitt, MD</last_name>
    <role>Study Director</role>
    <affiliation>CytRx Coorporation</affiliation>
  </overall_official>
  <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>April 2014</verification_date>
  <study_first_submitted>August 21, 2012</study_first_submitted>
  <study_first_submitted_qc>August 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 28, 2012</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>solid tumor</keyword>
  <keyword>aldoxorubicin</keyword>
  <keyword>phase 1</keyword>
  <keyword>INNO-206</keyword>
  <keyword>doxorubicin</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
  </condition_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/NCT01673438
org study id: ALDOXORUBICIN-P1-MTD-02
nct id: NCT01673438
lead sponsor: 
has dmc: No
This is a phase 1b open-label study to investigate the safety and maximum tolerated dose of
      aldoxorubicin plus doxorubicin HCl adminstered as infusion every 3 weeks for up to 8 cycles
      in subjects with advance solid tumors.
An Open-Label Phase 1b Study to Investigate the Safety and Maximum Tolerated Dose of
      Aldoxorubicin (INNO-206) Plus Doxorubicin HCl Administered as Infusions Every 3 Weeks in
      Subjects with Advanced Solid Tumors
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Safety and Tolerability
time frame: up to 6 months
description: The primary objective of this study is to determine the preliminary safety and maximum tolerated dose (MTD) of aldoxorubicin plus doxorubicin HCl in subjects with advanced solid tumors who have failed standard therapies.
measure: Tumor Response
time frame: up to 6 months
description: The secondary objective of this study is to evaluate the tumor response to aldoxorubicin plus doxorubicin HCl in this population assessed by radiographic means using the RECIST 1.1 criteria.
arm group label: Aldoxorubicin plus doxorubicin
arm group type: Experimental
description: Aldoxorubicin dosages of 175, 240, and 320 (doxorubicin equivalents of 130, 180, and 240 mg/m2) will be administered as a 30 minutes IVI on Day 1 of each cycle. In addition 35 mg/m2 of doxorubicin HCl will be administered as an IVI over > 3 minutes no later than 3 hours, but no more than 6 hours before the start of aldoxorubicin infusion.
intervention type: Drug
intervention name: aldoxorubicin
arm group label: Aldoxorubicin plus doxorubicin
other name: INNO-206
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Dan Levitt, MD
role: Study Director
affiliation: CytRx Coorporation
facility: 
country: United States
responsible party type: Sponsor
mesh term: Neoplasms