Back to resultsExpanded 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
About this trial
This is an expanded access trial for Glioblastoma
Eligibility Criteria
Inclusion Criteria: - Exclusion Criteria: -
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
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
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Primary Completion Date
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Study Completion Date
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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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