- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05974410
Expanded Access to Immunomodulatory AVM0703 for Solid Tumor and Blood Cancer Patients
September 29, 2025 updated by: AVM Biotechnology Inc
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.
Study Overview
Status
Available
Conditions
Intervention / Treatment
Study Type
Expanded Access
Expanded Access Type
- Individual Patients
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
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.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
N/A
Description
Inclusion Criteria:
-
Exclusion Criteria:
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Edward Loniewski, D.O., AVM Biotechnology Inc
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
First Submitted
July 26, 2023
First Submitted That Met QC Criteria
July 26, 2023
First Posted (Actual)
August 3, 2023
Study Record Updates
Last Update Posted (Estimated)
October 2, 2025
Last Update Submitted That Met QC Criteria
September 29, 2025
Last Verified
September 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Genital Diseases
- Endocrine System Diseases
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Genital Neoplasms, Male
- Urogenital Neoplasms
- Neoplasms by Site
- Genital Diseases, Male
- Prostatic Diseases
- Male Urogenital Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Immune System Diseases
- Neoplasms by Histologic Type
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Digestive System Diseases
- Gastrointestinal Diseases
- Stomach Diseases
- Genital Diseases, Female
- Endocrine Gland Neoplasms
- Pancreatic Diseases
- Neoplasms, Glandular and Epithelial
- Ovarian Diseases
- Adnexal Diseases
- Genital Neoplasms, Female
- Gonadal Disorders
- Skin Diseases
- Breast Diseases
- Lymphatic Diseases
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Carcinoma
- Neoplasms, Squamous Cell
- Astrocytoma
- Glioma
- Neoplasms, Neuroepithelial
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Lymphoma
- Nervous System Neoplasms
- Neoplasms, Connective and Soft Tissue
- Central Nervous System Neoplasms
- Skin and Connective Tissue Diseases
- Hemic and Lymphatic Diseases
- Neoplasms
- Prostatic Neoplasms
- Stomach Neoplasms
- Ovarian Neoplasms
- Breast Neoplasms
- Carcinoma, Squamous Cell
- Pancreatic Neoplasms
- Glioblastoma
- Lymphoma, Non-Hodgkin
- Sarcoma
- Hodgkin Disease
- Brain Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Enzyme Inhibitors
- Pharmacologic Actions
- Chemical Actions and Uses
- Polycyclic Compounds
- Pregnanes
- Steroids
- Fused-Ring Compounds
- Pregnenediones
- Pregnenes
- 11-Hydroxycorticosteroids
- Hydroxycorticosteroids
- Adrenal Cortex Hormones
- 17-Hydroxycorticosteroids
- Hydrocortisone
- Proton Pump Inhibitors
Other Study ID Numbers
- AVM0703-EAP
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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