xml: <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/NCT06026254</url>
    </required_header>
    <id_info>
      <org_study_id>IMSA101-101-R</org_study_id>
      <nct_id>NCT06026254</nct_id>
    </id_info>
    <brief_title>A Rollover Study for Subjects Who Completed Participation in IMSA101-101 Trial</brief_title>
    <official_title>Rollover Study to Continue IMSA101 Treatments in Patients With Advanced Treatment-Refractory Malignancies Previously Enrolled in the Phase I/IIA Safety and Efficacy Study of IMSA101</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>ImmuneSensor Therapeutics Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>ImmuneSensor Therapeutics Inc.</source>
    <oversight_info>
      <has_dmc>No</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 is a rollover study from parent protocol IMSA101-101 for adult patients with advanced&#xD;
        malignancies that were previously receiving IMSA101 and who would continue to receive benefit&#xD;
        with study treatment of IMSA101 in combination with an immune checkpoint inhibitor (ICI).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The following methodology applies to all patients:&#xD;
  &#xD;
          -  Treatment cycles will be 28 days in duration with lesions injected every 2 weeks.&#xD;
             IMSA101 dose level will remain the same as at the time of the rollover from parent&#xD;
             protocol.&#xD;
  &#xD;
          -  ICI dose level and treatment regimen will remain the same as at the time of the rollover&#xD;
             from parent protocol, following the labeled instructions.&#xD;
  &#xD;
          -  The same single pre-defined lesion/lesion site (longest diameter ≥ 10 mm and ≤ 50 mm)&#xD;
             shall be injected throughout study duration, if possible. Where the original injection&#xD;
             site is considered by the investigator to become inaccessible, a second lesion/lesion&#xD;
             site shall be selected as a replacement and this shall be used henceforth so long as it&#xD;
             is considered accessible. Subsequent injection sites shall be replaced when they are&#xD;
             considered inaccessible.&#xD;
  &#xD;
          -  Where no remaining accessible lesions are present and where benefit of IMSA101 therapy&#xD;
             is, in the opinion of the investigator, being derived by the patient, continued&#xD;
             injections of IMSA101 into the vicinity of an inaccessible lesion or, in the case that a&#xD;
             lesion can no longer be radiographically visualized, into the last known location of the&#xD;
             non-visible lesion shall be allowed.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">September 2024</completion_date>
    <primary_completion_date type="Anticipated">September 2024</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>Drug-related safety</measure>
      <time_frame>12 months</time_frame>
      <description>Frequency of drug-related SAE by subject</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Anti-tumor effects</measure>
      <time_frame>12 months</time_frame>
      <description>Tumor response based on RECIST v1.1</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">2</enrollment>
    <condition>Solid Tumor, Adult</condition>
    <arm_group>
      <arm_group_label>Combination Therapy</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>IMSA101 + ICI</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>IMSA101</intervention_name>
      <description>Intra-tumoral administration on Days 1 and 15 of every 28-day cycle</description>
      <arm_group_label>Combination Therapy</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Immune Checkpoint Inhibitor</intervention_name>
      <description>Administered according to product label</description>
      <arm_group_label>Combination Therapy</arm_group_label>
      <other_name>ICI</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Signed informed consent and mental capability to understand the informed consent&#xD;
  &#xD;
            2. Currently enrolled in parent protocol IMSA101-101 and is receiving IMSA101 treatment&#xD;
  &#xD;
            3. Deriving clinical benefit from study treatment, as determined by the investigator&#xD;
  &#xD;
            4. Must have fulfilled all required assessments in parent protocol IMSA101-101&#xD;
  &#xD;
            5. Male and female patients with reproductive potential must agree to use two forms of&#xD;
               highly effective contraception throughout the study&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Permanently discontinued from IMSA101 treatment in parent protocol IMSA101-101 for any&#xD;
               reason other than enrollment in the rollover study&#xD;
  &#xD;
            2. Failure to meet the criteria specified in parent protocol IMSA101-101 for continued&#xD;
               study treatment&#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>Teresa Mooneyham</last_name>
      <role>Study Chair</role>
      <affiliation>ImmuneSensor Therapeutics</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Teresa Mooneyham</last_name>
      <phone>210-380-5164</phone>
      <email>tmooneyham@immunesensor.com</email>
    </overall_contact>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 30, 2023</study_first_submitted>
    <study_first_submitted_qc>August 30, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 7, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Immune Checkpoint Inhibitors</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06026254
  org study id: IMSA101-101-R
  nct id: NCT06026254
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  This is a rollover study from parent protocol IMSA101-101 for adult patients with advanced
        malignancies that were previously receiving IMSA101 and who would continue to receive benefit
        with study treatment of IMSA101 in combination with an immune checkpoint inhibitor (ICI).
  The following methodology applies to all patients:
  
          -  Treatment cycles will be 28 days in duration with lesions injected every 2 weeks.
             IMSA101 dose level will remain the same as at the time of the rollover from parent
             protocol.
  
          -  ICI dose level and treatment regimen will remain the same as at the time of the rollover
             from parent protocol, following the labeled instructions.
  
          -  The same single pre-defined lesion/lesion site (longest diameter ≥ 10 mm and ≤ 50 mm)
             shall be injected throughout study duration, if possible. Where the original injection
             site is considered by the investigator to become inaccessible, a second lesion/lesion
             site shall be selected as a replacement and this shall be used henceforth so long as it
             is considered accessible. Subsequent injection sites shall be replaced when they are
             considered inaccessible.
  
          -  Where no remaining accessible lesions are present and where benefit of IMSA101 therapy
             is, in the opinion of the investigator, being derived by the patient, continued
             injections of IMSA101 into the vicinity of an inaccessible lesion or, in the case that a
             lesion can no longer be radiographically visualized, into the last known location of the
             non-visible lesion shall be allowed.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Drug-related safety
  time frame: 12 months
  description: Frequency of drug-related SAE by subject
  measure: Anti-tumor effects
  time frame: 12 months
  description: Tumor response based on RECIST v1.1
  arm group label: Combination Therapy
  arm group type: Experimental
  description: IMSA101 + ICI
  intervention type: Drug
  intervention name: IMSA101
  description: Intra-tumoral administration on Days 1 and 15 of every 28-day cycle
  arm group label: Combination Therapy
  intervention type: Drug
  intervention name: Immune Checkpoint Inhibitor
  description: Administered according to product label
  arm group label: Combination Therapy
  other name: ICI
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Teresa Mooneyham
  role: Study Chair
  affiliation: ImmuneSensor Therapeutics
  last name: Teresa Mooneyham
  phone: 210-380-5164
  email: tmooneyham@immunesensor.com
  responsible party type: Sponsor
  mesh term: Immune Checkpoint Inhibitors
  sharing ipd: No