<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/NCT04432207</url>
  </required_header>
  <id_info>
    <org_study_id>IMU.201.101</org_study_id>
    <nct_id>NCT04432207</nct_id>
  </id_info>
  <brief_title>A Study of IMU-201 (PD1-Vaxx), a B-Cell Immunotherapy, in Adults With Non-Small Cell Lung Cancer</brief_title>
  <official_title>An Open Label, Multi-Center, Dose Escalation/Expansion, Phase 1/1b Study of IMU-201, a B-Cell Immunotherapy as Monotherapy or in Combination With Atezolizumab With or Without Chemotherapy, in Adults With Non- Small Cell Lung Cancer (IMPrinter)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Imugene Limited</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Imugene Limited</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>
      An Open Label, Multi-Center, Dose Escalation/Expansion, Phase 1/1b Study of IMU 201&#xD;
      (PD1-Vaxx), a B-Cell Immunotherapy as monotherapy or in combination with atezolizumab with or&#xD;
      without chemotherapy, in Adults with Non-Small Cell Lung Cancer (IMPrinter).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Investigational Medicinal Product, IMU-201, consists of drug substance, APi2568, which is a&#xD;
      B-cell epitope (amino acids 92-110 from PD-1) linked to a promiscuous T-cell epitope (amino&#xD;
      acid residues 288-302 from measles virus fusion protein) via a 4-amino acid linker&#xD;
      (Gly-Pro-Ser-Leu), and combined with Water for Injection (WFI) forms the drug product,&#xD;
      IMU-201, which becomes PD1-Vaxx when emulsified with excipient Montanide ISA 720 VG.&#xD;
&#xD;
      It is hypothesized that a polyclonal induced B-cell antibody response will be more effective&#xD;
      or as effective with improved safety over current monoclonal antibody therapy.&#xD;
&#xD;
      This phase 1/1b study is an open-label dose escalation/dose expansion study designed to&#xD;
      assess the safety, tolerability, immunogenicity and efficacy of IMU-201 (PD1-Vaxx). Phase 1&#xD;
      monotherapy dose-escalation of IMU-201 (PD1-Vaxx), will enroll approximately 9-18 patients&#xD;
      and establish the optimal monotherapy biological dose (mBOD). Once established, the dose&#xD;
      cohort will be expanded to enroll additional 10 patients at the mBOD dose level. Phase 1b, a&#xD;
      combination dose-escalation of IMU-201 (PD1-Vaxx) with atezolizumab and with or without&#xD;
      chemotherapy, will enroll approximately 18-36 patients and establish the optimal combotherapy&#xD;
      biological dose (cBOD). Once established, the dose cohort will be expanded to enroll&#xD;
      additional 30 patients at the cBOD dose level.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 30, 2020</start_date>
  <completion_date type="Anticipated">March 2026</completion_date>
  <primary_completion_date type="Anticipated">February 2026</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>Sequential Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Safety and tolerability of IMU-201 graded per terminology criteria for adverse events (CTCAE) version 5.00 (Dose Escalation)</measure>
    <time_frame>Baseline to Day 29</time_frame>
    <description>Safety and Tolerability Measures include: Frequency of adverse events (AEs) graded per terminology criteria for adverse events (CTCAE) version 5.00.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Identify Optimal Biological Dose (OBD) with safety/tolerability graded per terminology criteria for adverse events (CTCAE) version 5.00 and Immuogenicity (Dose Escalation).</measure>
    <time_frame>Baseline to Day 43</time_frame>
    <description>Safety and Tolerability Measures: Adverse events (AEs); dose-limiting toxicities (DLTs) graded per terminology criteria for adverse events (CTCAE) version 5.00. Immunogenicity data for IMU-201 includes PD-1 specific antibody (IgG) titers.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall response rate (ORR) (Dose Expansion)</measure>
    <time_frame>Baseline to documented progressive disease (Approximately 15 months)</time_frame>
    <description>Efficacy of IMU-201 will be evaluated by overall response rate at OBD of IMU-201 measured as the proportion of participants with a best overall response of complete or partial response.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall response rate (ORR) (Dose Escalation)</measure>
    <time_frame>Baseline to documented progressive disease (Approximately 15 Months)</time_frame>
    <description>Efficacy of IMU-201 will be evaluated by overall response rate at OBD of IMU-201 measured as the proportion of participants with a best overall response of complete or partial response.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression free survival (PFS) (Dose Escalation/Expansion)</measure>
    <time_frame>Baseline to documented progressive disease or death due to any cause (Approximately 15 Months)</time_frame>
    <description>Efficacy of IMU-201 will be evaluated by progression free survival at OBD of IMU-201.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival (OS) (Dose Escalation/Expansion)</measure>
    <time_frame>Baseline to death from any cause (Approximately 15 Months)</time_frame>
    <description>Efficacy of IMU-201 will be evaluated by overall survival at OBD of IMU-201.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of response (DOR) (Dose Escalation/Expansion)</measure>
    <time_frame>From date of earliest CR or PR until the date of first documented progression or death from any cause (Approximately 15 Months)</time_frame>
    <description>Efficacy of IMU-201 will be evaluated by duration of response at OBD of IMU-201.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Exploratory Outcome: Humoral immunogenicity of IMU-201 (Dose Escalation/Expansion)</measure>
    <time_frame>Baseline to documented progressive disease (Approximately 15 Months)</time_frame>
    <description>Humoral immunogenicity evaluated by PD-1 specific antibodies (IgG, IgM).</description>
  </other_outcome>
  <other_outcome>
    <measure>Exploratory Outcome: Cellular immunogenicity of IMU-201 (Dose Escalation/Expansion)</measure>
    <time_frame>Baseline to documented progressive disease (Approximately 15 Months)</time_frame>
    <description>Cellular immunogenicity evaluated by vaccine-specific cytokine levels as well as analysis of regulatory and effector T and B cells.</description>
  </other_outcome>
  <number_of_arms>13</number_of_arms>
  <enrollment type="Anticipated">88</enrollment>
  <condition>Non Small Cell Lung Cancer</condition>
  <condition>Non Small Cell Lung Cancer Stage IIIB</condition>
  <condition>Non-small Cell Lung Cancer Stage IV</condition>
  <condition>Squamous Non-small-cell Lung Cancer</condition>
  <condition>Large Cell Carcinoma Lung</condition>
  <condition>Adenocarcinoma Lung</condition>
  <arm_group>
    <arm_group_label>Dose Escalation: Monotherapy Cohort 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>10 μg/dose IMU-201 as a 0.5 mL PD1-Vaxx injection Progressed on/after ICI, TPS/TC ≥50% or IC ≥10%</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dose Escalation: Monotherapy Cohort 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>50 μg/dose IMU-201 as a 0.5 mL PD1-Vaxx injection Progressed on/after ICI, TPS/TC ≥50% or IC ≥10%</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dose Escalation: Monotherapy Cohort 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>100 μg/dose IMU-201 as a 0.5 mL PD1-Vaxx injection Progressed on/after ICI, TPS/TC ≥50% or IC ≥10%</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dose Expansion Monotherapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>mOBD (TBD) dose IMU-201 as a 0.5 mL PD1-Vaxx injection Progressed on/after ICI, TPS/TC ≥50% or IC ≥10%</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dose Escalation Arm 1: Combination with atezolizumab Cohort 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>10 μg/dose IMU-201 as a 0.5 mL PD1-Vaxx injection with atezolizumab 840 mg Naïve to ICI or Progressed on/after ICI, TPS/TC ≥50% or IC ≥10%</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dose Escalation Arm 1: Combination with atezolizumab Cohort 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>50 μg/dose IMU-201 as a 0.5 mL PD1-Vaxx injection with atezolizumab 840 mg Naïve to ICI or Progressed on/after ICI, TPS/TC ≥50% or IC ≥10%</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dose Escalation Arm 1: Combination with atezolizumab Cohort 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cohort 3: 100 μg/dose IMU-201 as a 0.5 mL PD1-Vaxx injection with atezolizumab 840 mg Naïve to ICI or Progressed on/after ICI, TPS/TC ≥50% or IC ≥10%</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dose Escalation Arm 2: Combination with atezolizumab and chemotherapy Cohort 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>10 μg/dose IMU-201 as a 0.5 mL PD1-Vaxx injection with atezolizumab 840 mg and SOC chemotherapy Naïve to ICI, Any PD-L1 Level</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dose Escalation Arm 2: Combination with atezolizumab and chemotherapy Cohort 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>50 μg/dose IMU-201 as a 0.5 mL PD1-Vaxx injection with atezolizumab 840 mg and SOC chemotherapy Naïve to ICI, Any PD-L1 Level</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dose Escalation Arm 2: Combination with atezolizumab and chemotherapy Cohort 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>100 μg/dose IMU-201 as a 0.5 mL PD1-Vaxx injection with atezolizumab 840 mg and SOC chemotherapy Naïve to ICI, Any PD-L1 Level</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dose Expansion Arm 1: Combination with atezolizumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>cOBD (TBD) dose IMU-201 as a 0.5 mL PD1-Vaxx injection with atezolizumab 840 mg Progressed on/after ICI, TPS/TC ≥50% or IC ≥10%</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dose Expansion Arm 2: Combination with atezolizumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>cOBD (TBD) dose IMU-201 as a 0.5 mL PD1-Vaxx injection with atezolizumab 840 mg Naïve to ICI, TPS/TC ≥50% or IC ≥10%</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dose Expansion Arm 3: Combination with atezolizumab and chemotherapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>cOBD (TBD) dose IMU-201 as a 05 mL PD1-Vaxx injection with atezolizumab 840 mg and SOC chemotherapy Naïve to ICI, Any PD-L1 Level</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>IMU-201 (administered as PD1-Vaxx) - Regimen 1</intervention_name>
    <description>IMU-201 consists of APi2568 (lyophilized IMU-201) dissolved in WFI and emulsified with the adjuvant (Montanide ISA 720 VG) to produce PD1-Vaxx. IMU-201 will be administered as PD1-Vaxx intramuscularly into the deltoid region of the upper arm on Days 1, 15, 29, 64 and thereafter every 63 days until discontinuation from study.</description>
    <arm_group_label>Dose Escalation: Monotherapy Cohort 1</arm_group_label>
    <arm_group_label>Dose Escalation: Monotherapy Cohort 2</arm_group_label>
    <arm_group_label>Dose Escalation: Monotherapy Cohort 3</arm_group_label>
    <arm_group_label>Dose Expansion Monotherapy</arm_group_label>
    <other_name>PD1-Vaxx</other_name>
    <other_name>APi2568</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>IMU-201 (administered as PD1-Vaxx) - Regimen 2</intervention_name>
    <description>IMU-201 consists of APi2568 (lyophilized IMU-201) dissolved in WFI and emulsified with the adjuvant (Montanide ISA 720 VG) to produce PD1-Vaxx. IMU-201 will be administered as PD1-Vaxx intramuscularly into the deltoid region of the upper arm on Days 1, 15, 29, 57 and thereafter every subsequent 63 days until discontinuation from study.</description>
    <arm_group_label>Dose Escalation Arm 1: Combination with atezolizumab Cohort 1</arm_group_label>
    <arm_group_label>Dose Escalation Arm 1: Combination with atezolizumab Cohort 2</arm_group_label>
    <arm_group_label>Dose Escalation Arm 1: Combination with atezolizumab Cohort 3</arm_group_label>
    <arm_group_label>Dose Expansion Arm 1: Combination with atezolizumab</arm_group_label>
    <arm_group_label>Dose Expansion Arm 2: Combination with atezolizumab</arm_group_label>
    <other_name>PD1-Vaxx</other_name>
    <other_name>APi2568</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>IMU-201 (administered as PD1-Vaxx) - Regimen 3</intervention_name>
    <description>IMU-201 consists of APi2568 (lyophilized IMU-201) dissolved in WFI and emulsified with the adjuvant (Montanide ISA 720 VG) to produce PD1-Vaxx. IMU-201 will be administered as PD1-Vaxx intramuscularly into the deltoid region of the upper arm on Days 1, 15, 29, 57 and thereafter every 56 or 63 days until discontinuation from study.</description>
    <arm_group_label>Dose Escalation Arm 2: Combination with atezolizumab and chemotherapy Cohort 1</arm_group_label>
    <arm_group_label>Dose Escalation Arm 2: Combination with atezolizumab and chemotherapy Cohort 2</arm_group_label>
    <arm_group_label>Dose Escalation Arm 2: Combination with atezolizumab and chemotherapy Cohort 3</arm_group_label>
    <arm_group_label>Dose Expansion Arm 3: Combination with atezolizumab and chemotherapy</arm_group_label>
    <other_name>PD1-Vaxx</other_name>
    <other_name>APi2568</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Atezolizumab</intervention_name>
    <description>Atezolizumab will be administered every 2 weeks (Q2W) starting Day 15 until discontinuation from study.</description>
    <arm_group_label>Dose Escalation Arm 1: Combination with atezolizumab Cohort 1</arm_group_label>
    <arm_group_label>Dose Escalation Arm 1: Combination with atezolizumab Cohort 2</arm_group_label>
    <arm_group_label>Dose Escalation Arm 1: Combination with atezolizumab Cohort 3</arm_group_label>
    <arm_group_label>Dose Escalation Arm 2: Combination with atezolizumab and chemotherapy Cohort 1</arm_group_label>
    <arm_group_label>Dose Escalation Arm 2: Combination with atezolizumab and chemotherapy Cohort 2</arm_group_label>
    <arm_group_label>Dose Escalation Arm 2: Combination with atezolizumab and chemotherapy Cohort 3</arm_group_label>
    <arm_group_label>Dose Expansion Arm 1: Combination with atezolizumab</arm_group_label>
    <arm_group_label>Dose Expansion Arm 2: Combination with atezolizumab</arm_group_label>
    <arm_group_label>Dose Expansion Arm 3: Combination with atezolizumab and chemotherapy</arm_group_label>
    <other_name>TECENTRIQ</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Standard of care chemotherapy</intervention_name>
    <description>Chemotherapy to be administered according to the prescribing information.</description>
    <arm_group_label>Dose Escalation Arm 2: Combination with atezolizumab and chemotherapy Cohort 1</arm_group_label>
    <arm_group_label>Dose Escalation Arm 2: Combination with atezolizumab and chemotherapy Cohort 2</arm_group_label>
    <arm_group_label>Dose Escalation Arm 2: Combination with atezolizumab and chemotherapy Cohort 3</arm_group_label>
    <arm_group_label>Dose Expansion Arm 3: Combination with atezolizumab and chemotherapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age ≥ 18 years with histologically confirmed non-small-cell lung cancer (NSCLC) tumor&#xD;
             stage IIIb not eligible for definitive treatment or stage IV&#xD;
&#xD;
          2. Prior treatment criterion for Monotherapy dose escalation and expansion: progressed&#xD;
             on/after prior PD-1/PD-L1 containing regimen&#xD;
&#xD;
          3. Prior treatment criteria for Combination dose escalation arms:&#xD;
&#xD;
               1. IMU-201 + atezolizumab, patients naïve to prior treatment or progressed on/after&#xD;
                  prior PD-1/PD-L1 containing regimen&#xD;
&#xD;
               2. IMU-201 + atezolizumab + chemotherapy, patient naïve to prior treatment naive&#xD;
&#xD;
          4. Prior treatment criteria for Combination dose expansion arms:&#xD;
&#xD;
               1. IMU-201 + atezolizumab, progressed on/after prior PD-1/PD-L1 containing regimen&#xD;
&#xD;
               2. IMU-201 + atezolizumab, patients naïve to prior treatment&#xD;
&#xD;
               3. IMU-201 + atezolizumab + chemotherapy, patients naïve to prior treatment&#xD;
&#xD;
          5. PD-L1 expression criteria (testing by 22C3, SP142, or SP263) for Monotherapy dose&#xD;
             escalation and expansion: TPS/TC ≥ 50% or IC ≥ 10%. Patients with PD-L1 TPS/TC&lt;50% or&#xD;
             IC&lt;10% expression may be included with agreement of Sponsor&#xD;
&#xD;
          6. PD-L1 expression criteria for Combination dose escalation arms:&#xD;
&#xD;
               1. IMU-201 + atezolizumab, TPS/TC ≥ 50% or IC ≥ 10%&#xD;
&#xD;
               2. IMU-201 + atezolizumab + chemotherapy, independent of PD-L1 expression&#xD;
&#xD;
          7. PD-L1 expression criteria for Combination dose expansion arms:&#xD;
&#xD;
               1. IMU-201 + atezolizumab, TPS/TC ≥ 50% or IC ≥ 10%&#xD;
&#xD;
               2. IMU-201 + atezolizumab, TPS/TC ≥ 50% or IC ≥ 10%&#xD;
&#xD;
               3. IMU-201 + atezolizumab + chemotherapy, independent of PD-L1 expression&#xD;
&#xD;
          8. Life expectancy of at least 12 weeks in the opinion of the Investigator&#xD;
&#xD;
          9. Zubrod/ECOG score performance status 0-1&#xD;
&#xD;
         10. At least one measurable lesion as defined by RECIST 1.1 criteria.&#xD;
&#xD;
         11. Adequate hematologic, liver, and renal function&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Prior therapy for advanced NSCLC within 3 weeks prior to Day 1;&#xD;
&#xD;
          2. Continuous systemic treatment with either corticosteroids (&gt; 10 mg daily prednisone&#xD;
             equivalents) or other immunosuppressive medications within 2 weeks prior to first dose&#xD;
             of study treatment.;&#xD;
&#xD;
          3. Any previous grade 3 or higher toxicity to a PD-1 inhibitor or PD-L1 inhibitor;&#xD;
&#xD;
          4. Has a history of (non-infectious) pneumonitis/interstitial lung disease that required&#xD;
             treatment with immunosuppressive agents or has current pneumonitis/interstitial lung&#xD;
             disease;&#xD;
&#xD;
          5. Known brain metastases requiring steroid treatment, or signs and symptoms indicating&#xD;
             suspected brain metastases;&#xD;
&#xD;
          6. Current or previous history of auto-immune disease;&#xD;
&#xD;
          7. NSCLC expressing epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase&#xD;
             (ALK), B-Raf proto-oncogene (BRAF) or ROS proto-oncogene 1 (ROS1) mutations who have&#xD;
             not received appropriate therapies targeting these mutations and progress (if&#xD;
             treatments are not available, patients who have NOT received appropriate therapies may&#xD;
             be enrolled);&#xD;
&#xD;
          8. Prior organ transplant;&#xD;
&#xD;
          9. Concurrent active malignancy except for adequately controlled limited basal cell&#xD;
             carcinoma of the skin;&#xD;
&#xD;
         10. History of uncontrolled seizures, central nervous disorders, or psychiatric disability&#xD;
             judged by the Investigator to be clinically significant and precluding informed&#xD;
             consent, participation in the study, or adversely affecting compliance to study drugs;&#xD;
&#xD;
         11. Active infection requiring intravenous antibiotics;&#xD;
&#xD;
         12. Known history of human immunodeficiency virus (HIV) infection or Hepatitis B (defined&#xD;
             as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus&#xD;
             (defined as HCV Ribonucleic acid (RNA) [qualitative] is detected) infection;&#xD;
&#xD;
         13. Major surgery within 4 weeks prior to study entry. Minor surgery (excluding diagnostic&#xD;
             biopsy) within 1 week prior to study entry;&#xD;
&#xD;
         14. Any vaccination within 2 weeks prior to starting study treatment;&#xD;
&#xD;
         15. Treatment with any investigational drug or participation in another investigational&#xD;
             study within 3 weeks prior to first IMU-201 dose.&#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_contact>
    <last_name>Yuni Kim</last_name>
    <phone>+61 2 9423 0881</phone>
    <email>info@imugene.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85054</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hackensack University Medical Center</name>
      <address>
        <city>Hackensack</city>
        <state>New Jersey</state>
        <zip>07601</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Ohio State University Medical Center</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Chris O'Brien Lifehouse</name>
      <address>
        <city>Camperdown</city>
        <state>New South Wales</state>
        <zip>2050</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Macquarie University</name>
      <address>
        <city>Macquarie</city>
        <state>New South Wales</state>
        <zip>2109</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Cabrini Malvern Hospital</name>
      <address>
        <city>Melbourne</city>
        <state>Victoria</state>
        <zip>3000</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.imugene.com/</url>
    <description>Imugene Limited</description>
  </link>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>May 10, 2020</study_first_submitted>
  <study_first_submitted_qc>June 11, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>April 18, 2023</last_update_submitted>
  <last_update_submitted_qc>April 18, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 20, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Non-Small-Cell Lung</mesh_term>
    <mesh_term>Carcinoma, Large Cell</mesh_term>
    <mesh_term>Adenocarcinoma of Lung</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atezolizumab</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/NCT04432207
org study id: IMU.201.101
nct id: NCT04432207
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
An Open Label, Multi-Center, Dose Escalation/Expansion, Phase 1/1b Study of IMU 201
      (PD1-Vaxx), a B-Cell Immunotherapy as monotherapy or in combination with atezolizumab with or
      without chemotherapy, in Adults with Non-Small Cell Lung Cancer (IMPrinter).
Investigational Medicinal Product, IMU-201, consists of drug substance, APi2568, which is a
      B-cell epitope (amino acids 92-110 from PD-1) linked to a promiscuous T-cell epitope (amino
      acid residues 288-302 from measles virus fusion protein) via a 4-amino acid linker
      (Gly-Pro-Ser-Leu), and combined with Water for Injection (WFI) forms the drug product,
      IMU-201, which becomes PD1-Vaxx when emulsified with excipient Montanide ISA 720 VG.

      It is hypothesized that a polyclonal induced B-cell antibody response will be more effective
      or as effective with improved safety over current monoclonal antibody therapy.

      This phase 1/1b study is an open-label dose escalation/dose expansion study designed to
      assess the safety, tolerability, immunogenicity and efficacy of IMU-201 (PD1-Vaxx). Phase 1
      monotherapy dose-escalation of IMU-201 (PD1-Vaxx), will enroll approximately 9-18 patients
      and establish the optimal monotherapy biological dose (mBOD). Once established, the dose
      cohort will be expanded to enroll additional 10 patients at the mBOD dose level. Phase 1b, a
      combination dose-escalation of IMU-201 (PD1-Vaxx) with atezolizumab and with or without
      chemotherapy, will enroll approximately 18-36 patients and establish the optimal combotherapy
      biological dose (cBOD). Once established, the dose cohort will be expanded to enroll
      additional 30 patients at the cBOD dose level.
allocation: Non-Randomized
intervention model: Sequential Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Safety and tolerability of IMU-201 graded per terminology criteria for adverse events (CTCAE) version 5.00 (Dose Escalation)
time frame: Baseline to Day 29
description: Safety and Tolerability Measures include: Frequency of adverse events (AEs) graded per terminology criteria for adverse events (CTCAE) version 5.00.
measure: Identify Optimal Biological Dose (OBD) with safety/tolerability graded per terminology criteria for adverse events (CTCAE) version 5.00 and Immuogenicity (Dose Escalation).
time frame: Baseline to Day 43
description: Safety and Tolerability Measures: Adverse events (AEs); dose-limiting toxicities (DLTs) graded per terminology criteria for adverse events (CTCAE) version 5.00. Immunogenicity data for IMU-201 includes PD-1 specific antibody (IgG) titers.
measure: Overall response rate (ORR) (Dose Expansion)
time frame: Baseline to documented progressive disease (Approximately 15 months)
description: Efficacy of IMU-201 will be evaluated by overall response rate at OBD of IMU-201 measured as the proportion of participants with a best overall response of complete or partial response.
measure: Overall response rate (ORR) (Dose Escalation)
time frame: Baseline to documented progressive disease (Approximately 15 Months)
description: Efficacy of IMU-201 will be evaluated by overall response rate at OBD of IMU-201 measured as the proportion of participants with a best overall response of complete or partial response.
measure: Progression free survival (PFS) (Dose Escalation/Expansion)
time frame: Baseline to documented progressive disease or death due to any cause (Approximately 15 Months)
description: Efficacy of IMU-201 will be evaluated by progression free survival at OBD of IMU-201.
measure: Overall survival (OS) (Dose Escalation/Expansion)
time frame: Baseline to death from any cause (Approximately 15 Months)
description: Efficacy of IMU-201 will be evaluated by overall survival at OBD of IMU-201.
measure: Duration of response (DOR) (Dose Escalation/Expansion)
time frame: From date of earliest CR or PR until the date of first documented progression or death from any cause (Approximately 15 Months)
description: Efficacy of IMU-201 will be evaluated by duration of response at OBD of IMU-201.
measure: Exploratory Outcome: Humoral immunogenicity of IMU-201 (Dose Escalation/Expansion)
time frame: Baseline to documented progressive disease (Approximately 15 Months)
description: Humoral immunogenicity evaluated by PD-1 specific antibodies (IgG, IgM).
measure: Exploratory Outcome: Cellular immunogenicity of IMU-201 (Dose Escalation/Expansion)
time frame: Baseline to documented progressive disease (Approximately 15 Months)
description: Cellular immunogenicity evaluated by vaccine-specific cytokine levels as well as analysis of regulatory and effector T and B cells.
arm group label: Dose Escalation: Monotherapy Cohort 1
arm group type: Experimental
description: 10 μg/dose IMU-201 as a 0.5 mL PD1-Vaxx injection Progressed on/after ICI, TPS/TC ≥50% or IC ≥10%
arm group label: Dose Escalation: Monotherapy Cohort 2
arm group type: Experimental
description: 50 μg/dose IMU-201 as a 0.5 mL PD1-Vaxx injection Progressed on/after ICI, TPS/TC ≥50% or IC ≥10%
arm group label: Dose Escalation: Monotherapy Cohort 3
arm group type: Experimental
description: 100 μg/dose IMU-201 as a 0.5 mL PD1-Vaxx injection Progressed on/after ICI, TPS/TC ≥50% or IC ≥10%
arm group label: Dose Expansion Monotherapy
arm group type: Experimental
description: mOBD (TBD) dose IMU-201 as a 0.5 mL PD1-Vaxx injection Progressed on/after ICI, TPS/TC ≥50% or IC ≥10%
arm group label: Dose Escalation Arm 1: Combination with atezolizumab Cohort 1
arm group type: Experimental
description: 10 μg/dose IMU-201 as a 0.5 mL PD1-Vaxx injection with atezolizumab 840 mg Naïve to ICI or Progressed on/after ICI, TPS/TC ≥50% or IC ≥10%
arm group label: Dose Escalation Arm 1: Combination with atezolizumab Cohort 2
arm group type: Experimental
description: 50 μg/dose IMU-201 as a 0.5 mL PD1-Vaxx injection with atezolizumab 840 mg Naïve to ICI or Progressed on/after ICI, TPS/TC ≥50% or IC ≥10%
arm group label: Dose Escalation Arm 1: Combination with atezolizumab Cohort 3
arm group type: Experimental
description: Cohort 3: 100 μg/dose IMU-201 as a 0.5 mL PD1-Vaxx injection with atezolizumab 840 mg Naïve to ICI or Progressed on/after ICI, TPS/TC ≥50% or IC ≥10%
arm group label: Dose Escalation Arm 2: Combination with atezolizumab and chemotherapy Cohort 1
arm group type: Experimental
description: 10 μg/dose IMU-201 as a 0.5 mL PD1-Vaxx injection with atezolizumab 840 mg and SOC chemotherapy Naïve to ICI, Any PD-L1 Level
arm group label: Dose Escalation Arm 2: Combination with atezolizumab and chemotherapy Cohort 2
arm group type: Experimental
description: 50 μg/dose IMU-201 as a 0.5 mL PD1-Vaxx injection with atezolizumab 840 mg and SOC chemotherapy Naïve to ICI, Any PD-L1 Level
arm group label: Dose Escalation Arm 2: Combination with atezolizumab and chemotherapy Cohort 3
arm group type: Experimental
description: 100 μg/dose IMU-201 as a 0.5 mL PD1-Vaxx injection with atezolizumab 840 mg and SOC chemotherapy Naïve to ICI, Any PD-L1 Level
arm group label: Dose Expansion Arm 1: Combination with atezolizumab
arm group type: Experimental
description: cOBD (TBD) dose IMU-201 as a 0.5 mL PD1-Vaxx injection with atezolizumab 840 mg Progressed on/after ICI, TPS/TC ≥50% or IC ≥10%
arm group label: Dose Expansion Arm 2: Combination with atezolizumab
arm group type: Experimental
description: cOBD (TBD) dose IMU-201 as a 0.5 mL PD1-Vaxx injection with atezolizumab 840 mg Naïve to ICI, TPS/TC ≥50% or IC ≥10%
arm group label: Dose Expansion Arm 3: Combination with atezolizumab and chemotherapy
arm group type: Experimental
description: cOBD (TBD) dose IMU-201 as a 05 mL PD1-Vaxx injection with atezolizumab 840 mg and SOC chemotherapy Naïve to ICI, Any PD-L1 Level
intervention type: Biological
intervention name: IMU-201 (administered as PD1-Vaxx) - Regimen 1
description: IMU-201 consists of APi2568 (lyophilized IMU-201) dissolved in WFI and emulsified with the adjuvant (Montanide ISA 720 VG) to produce PD1-Vaxx. IMU-201 will be administered as PD1-Vaxx intramuscularly into the deltoid region of the upper arm on Days 1, 15, 29, 64 and thereafter every 63 days until discontinuation from study.
arm group label: Dose Escalation: Monotherapy Cohort 1
arm group label: Dose Escalation: Monotherapy Cohort 2
arm group label: Dose Escalation: Monotherapy Cohort 3
arm group label: Dose Expansion Monotherapy
other name: PD1-Vaxx
other name: APi2568
intervention type: Biological
intervention name: IMU-201 (administered as PD1-Vaxx) - Regimen 2
description: IMU-201 consists of APi2568 (lyophilized IMU-201) dissolved in WFI and emulsified with the adjuvant (Montanide ISA 720 VG) to produce PD1-Vaxx. IMU-201 will be administered as PD1-Vaxx intramuscularly into the deltoid region of the upper arm on Days 1, 15, 29, 57 and thereafter every subsequent 63 days until discontinuation from study.
arm group label: Dose Escalation Arm 1: Combination with atezolizumab Cohort 1
arm group label: Dose Escalation Arm 1: Combination with atezolizumab Cohort 2
arm group label: Dose Escalation Arm 1: Combination with atezolizumab Cohort 3
arm group label: Dose Expansion Arm 1: Combination with atezolizumab
arm group label: Dose Expansion Arm 2: Combination with atezolizumab
other name: PD1-Vaxx
other name: APi2568
intervention type: Biological
intervention name: IMU-201 (administered as PD1-Vaxx) - Regimen 3
description: IMU-201 consists of APi2568 (lyophilized IMU-201) dissolved in WFI and emulsified with the adjuvant (Montanide ISA 720 VG) to produce PD1-Vaxx. IMU-201 will be administered as PD1-Vaxx intramuscularly into the deltoid region of the upper arm on Days 1, 15, 29, 57 and thereafter every 56 or 63 days until discontinuation from study.
arm group label: Dose Escalation Arm 2: Combination with atezolizumab and chemotherapy Cohort 1
arm group label: Dose Escalation Arm 2: Combination with atezolizumab and chemotherapy Cohort 2
arm group label: Dose Escalation Arm 2: Combination with atezolizumab and chemotherapy Cohort 3
arm group label: Dose Expansion Arm 3: Combination with atezolizumab and chemotherapy
other name: PD1-Vaxx
other name: APi2568
intervention type: Drug
intervention name: Atezolizumab
description: Atezolizumab will be administered every 2 weeks (Q2W) starting Day 15 until discontinuation from study.
arm group label: Dose Escalation Arm 1: Combination with atezolizumab Cohort 1
arm group label: Dose Escalation Arm 1: Combination with atezolizumab Cohort 2
arm group label: Dose Escalation Arm 1: Combination with atezolizumab Cohort 3
arm group label: Dose Escalation Arm 2: Combination with atezolizumab and chemotherapy Cohort 1
arm group label: Dose Escalation Arm 2: Combination with atezolizumab and chemotherapy Cohort 2
arm group label: Dose Escalation Arm 2: Combination with atezolizumab and chemotherapy Cohort 3
arm group label: Dose Expansion Arm 1: Combination with atezolizumab
arm group label: Dose Expansion Arm 2: Combination with atezolizumab
arm group label: Dose Expansion Arm 3: Combination with atezolizumab and chemotherapy
other name: TECENTRIQ
intervention type: Drug
intervention name: Standard of care chemotherapy
description: Chemotherapy to be administered according to the prescribing information.
arm group label: Dose Escalation Arm 2: Combination with atezolizumab and chemotherapy Cohort 1
arm group label: Dose Escalation Arm 2: Combination with atezolizumab and chemotherapy Cohort 2
arm group label: Dose Escalation Arm 2: Combination with atezolizumab and chemotherapy Cohort 3
arm group label: Dose Expansion Arm 3: Combination with atezolizumab and chemotherapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Yuni Kim
phone: +61 2 9423 0881
email: info@imugene.com
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
country: Australia
country: United States
url: https://www.imugene.com/
description: Imugene Limited
responsible party type: Sponsor
mesh term: Lung Neoplasms
mesh term: Carcinoma, Non-Small-Cell Lung
mesh term: Carcinoma, Large Cell
mesh term: Adenocarcinoma of Lung
mesh term: Atezolizumab