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Expanded Access to Immunomodulatory AVM0703 for Solid Tumor and Blood Cancer Patients
Study Purpose
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.
Recruitment Criteria
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Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
Unknown |
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Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Expanded Access |
| Eligible Ages | N/A and Over |
| Gender | All |
Trial Details
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Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT05974410 |
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Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
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Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
AVM Biotechnology Inc |
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Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Edward Loniewski, D.O. |
| Principal Investigator Affiliation | AVM Biotechnology Inc |
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Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
| Overall Status | Available |
| Countries | |
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Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
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 |
Contact Information
This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:
Mia Lor
For additional contact information, you can also visit the trial on clinicaltrials.gov.
