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Expanded Access to Immunomodulatory AVM0703 for Solid Tumor and Blood Cancer Patients

Primary Purpose

Glioblastoma, Squamous Cell Carcinoma, Hodgkin Lymphoma

Status
Available
Phase
Locations
Study Type
Expanded Access
Intervention
AVM0703
Hydrocortisone
Proton pump inhibitor
Sponsored by
AVM Biotechnology Inc
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Glioblastoma

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All Sexes

Inclusion Criteria: - Exclusion Criteria: -

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    July 26, 2023
    Last Updated
    July 26, 2023
    Sponsor
    AVM Biotechnology Inc
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05974410
    Brief Title
    Expanded Access to Immunomodulatory AVM0703 for Solid Tumor and Blood Cancer Patients
    Study Type
    Expanded Access

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Available
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    AVM Biotechnology Inc

    4. Oversight

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Glioblastoma, Squamous Cell Carcinoma, Hodgkin Lymphoma, Non-hodgkin Lymphoma, Breast Cancer, Prostate Cancer, Gastric Cancer, Ovarian Cancer, Acute Leukemia, Pancreatic Cancer, Spindle Cell Sarcoma, Cancer, Tumor, Solid, Tumor, Brain

    7. Study Design

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    AVM0703
    Intervention Description
    small molecule immunomodulatory drug
    Intervention Type
    Drug
    Intervention Name(s)
    Hydrocortisone
    Intervention Description
    physiologic circadian glucocorticoid
    Intervention Type
    Drug
    Intervention Name(s)
    Proton pump inhibitor

    10. Eligibility

    Sex
    All
    Eligibility Criteria
    Inclusion Criteria: - Exclusion Criteria: -
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mia Lor
    Phone
    12062607770
    Email
    mlor@avmbiotech.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Theresa A DEISHER, PhD
    Phone
    12068513942
    Email
    tdeisher@avmbiotech.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Edward Loniewski, D.O.
    Organizational Affiliation
    AVM Biotechnology Inc
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Expanded Access to Immunomodulatory AVM0703 for Solid Tumor and Blood Cancer Patients

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