Expanded Access to Immunomodulatory AVM0703 for Solid Tumor and Blood Cancer Patients
NCT05974410 · Status: AVAILABLE · Type: EXPANDED_ACCESS
Last updated 2025-10-02
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 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.
Conditions
- 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
Interventions
- DRUG
-
AVM0703
small molecule immunomodulatory drug
- DRUG
-
Hydrocortisone
physiologic circadian glucocorticoid
- DRUG
-
Proton pump inhibitor
Sponsors & Collaborators
-
AVM Biotechnology Inc
lead INDUSTRY
Principal Investigators
-
Edward Loniewski, D.O. · AVM Biotechnology Inc
Eligibility
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
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