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


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Study Overview

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

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 2024, 37 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 and metastatic pancreatic cancer. Drug-related side-effects are predominantly grade 1 and include itching during the infusion and about 1 week of low grade insomnia.

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  • 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
  • Esophageal Andeocarcinoma
  • Mixed Phenotype AML
  • Desmoplastic Round Cell Sarcoma
  • DRUG: AVM0703
  • DRUG: Hydrocortisone
  • DRUG: Proton pump inhibitor
  • AVM0703-EAP

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2023-07-26  

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2024-07-29  

2023-07-26  

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2024-07-31  

2023-08-03  

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2024-07  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
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Allocation:
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Interventional Model:
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Masking:
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Arms and Interventions

Participant Group/ArmIntervention/Treatment
Secondary Outcome MeasuresMeasure DescriptionTime Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Mia Lor

Phone Number: 12062607770

Email: mlor@avmbiotech.com

Study Contact Backup

Name: Theresa A DEISHER, PhD

Phone Number: 12068513942

Email: tdeisher@avmbiotech.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:

Accepts Healthy Volunteers:

    Inclusion Criteria:
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    Exclusion Criteria:
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Collaborators and Investigators

This is where you will find people and organizations involved with this study.


    • STUDY_DIRECTOR: Edward Loniewski, D.O., AVM Biotechnology Inc

    Publications

    The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

    General Publications

    No publications available