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/NCT05974410</url>
    </required_header>
    <id_info>
      <org_study_id>AVM0703-EAP</org_study_id>
      <nct_id>NCT05974410</nct_id>
    </id_info>
    <brief_title>Expanded Access to Immunomodulatory AVM0703 for Solid Tumor and Blood Cancer Patients</brief_title>
    <sponsors>
      <lead_sponsor>
        <agency>AVM Biotechnology Inc</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>AVM Biotechnology Inc</source>
    <brief_summary>
      <textblock>
        AVM Biotechnology, Inc., provides immunomodulatory AVM0703 to solid tumor and blood cancer&#xD;
        patients upon request by a US licensed MD or DO. As of July 2023, 22 patients have been&#xD;
        treated through this FDA-EAP including patients diagnosed with relapsed or recurring&#xD;
        glioblastoma, inoperable/chemotherapy ineligible CNS Squamous Cell Carcinoma, metastatic&#xD;
        Breast Cancer, ovarian cancer, gastric cancer, Hodgkin's Lymphoma, Mixed Phenotype Acute&#xD;
        Myelogenous Leukemia, colon cancer, B-ALL, Malignant Myxoid Spindle Cell Neoplasm, non-small&#xD;
        cell lung cancer, DLBCL with CNS involvement, metastatic prostate cancer, Anaplastic T-cell&#xD;
        Non-Hodgkin's Lymphoma.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Available</overall_status>
    <study_type>Expanded Access</study_type>
    <has_expanded_access>No</has_expanded_access>
    <expanded_access_info>
      <expanded_access_type_individual>Yes</expanded_access_type_individual>
    </expanded_access_info>
    <condition>Glioblastoma</condition>
    <condition>Squamous Cell Carcinoma</condition>
    <condition>Hodgkin Lymphoma</condition>
    <condition>Non-hodgkin Lymphoma</condition>
    <condition>Breast Cancer</condition>
    <condition>Prostate Cancer</condition>
    <condition>Gastric Cancer</condition>
    <condition>Ovarian Cancer</condition>
    <condition>Acute Leukemia</condition>
    <condition>Pancreatic Cancer</condition>
    <condition>Spindle Cell Sarcoma</condition>
    <condition>Cancer</condition>
    <condition>Tumor, Solid</condition>
    <condition>Tumor, Brain</condition>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>AVM0703</intervention_name>
      <description>small molecule immunomodulatory drug</description>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Hydrocortisone</intervention_name>
      <description>physiologic circadian glucocorticoid</description>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Proton pump inhibitor</intervention_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          -&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          -&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
    </eligibility>
    <overall_official>
      <last_name>Edward Loniewski, D.O.</last_name>
      <role>Study Director</role>
      <affiliation>AVM Biotechnology Inc</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Mia Lor</last_name>
      <phone>12062607770</phone>
      <email>mlor@avmbiotech.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Theresa A DEISHER, PhD</last_name>
      <phone>12068513942</phone>
      <email>tdeisher@avmbiotech.com</email>
    </overall_contact_backup>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 26, 2023</study_first_submitted>
    <study_first_submitted_qc>July 26, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 3, 2023</study_first_posted>
    <last_update_submitted>July 26, 2023</last_update_submitted>
    <last_update_submitted_qc>July 26, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 3, 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>Lymphoma</mesh_term>
      <mesh_term>Neoplasms</mesh_term>
      <mesh_term>Sarcoma</mesh_term>
      <mesh_term>Glioblastoma</mesh_term>
      <mesh_term>Brain Neoplasms</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hydrocortisone</mesh_term>
      <mesh_term>Proton Pump Inhibitors</mesh_term>
    </intervention_browse>
    <!-- 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/NCT05974410
  org study id: AVM0703-EAP
  nct id: NCT05974410
  lead sponsor: 
  AVM Biotechnology, Inc., provides immunomodulatory AVM0703 to solid tumor and blood cancer
        patients upon request by a US licensed MD or DO. As of July 2023, 22 patients have been
        treated through this FDA-EAP including patients diagnosed with relapsed or recurring
        glioblastoma, inoperable/chemotherapy ineligible CNS Squamous Cell Carcinoma, metastatic
        Breast Cancer, ovarian cancer, gastric cancer, Hodgkin's Lymphoma, Mixed Phenotype Acute
        Myelogenous Leukemia, colon cancer, B-ALL, Malignant Myxoid Spindle Cell Neoplasm, non-small
        cell lung cancer, DLBCL with CNS involvement, metastatic prostate cancer, Anaplastic T-cell
        Non-Hodgkin's Lymphoma.
  expanded access type individual: Yes
  intervention type: Drug
  intervention name: AVM0703
  description: small molecule immunomodulatory drug
  intervention type: Drug
  intervention name: Hydrocortisone
  description: physiologic circadian glucocorticoid
  intervention type: Drug
  intervention name: Proton pump inhibitor
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  last name: Edward Loniewski, D.O.
  role: Study Director
  affiliation: AVM Biotechnology Inc
  last name: Mia Lor
  phone: 12062607770
  email: mlor@avmbiotech.com
  last name: Theresa A DEISHER, PhD
  phone: 12068513942
  email: tdeisher@avmbiotech.com
  responsible party type: Sponsor
  mesh term: Lymphoma
  mesh term: Neoplasms
  mesh term: Sarcoma
  mesh term: Glioblastoma
  mesh term: Brain Neoplasms
  mesh term: Hydrocortisone
  mesh term: Proton Pump Inhibitors