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Trial Title:
Expanded Access to Immunomodulatory AVM0703 for Solid Tumor and Blood Cancer Patients
NCT ID:
NCT05974410
Condition:
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
Conditions: Official terms:
Lymphoma
Neoplasms
Sarcoma
Glioblastoma
Brain Neoplasms
Hydrocortisone
Proton Pump Inhibitors
Study type:
Expanded Access
Overall status:
Available
Intervention:
Intervention type:
Drug
Intervention name:
AVM0703
Description:
small molecule immunomodulatory drug
Intervention type:
Drug
Intervention name:
Hydrocortisone
Description:
physiologic circadian glucocorticoid
Intervention type:
Drug
Intervention name:
Proton pump inhibitor
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Exclusion Criteria:
-
Gender:
All
Minimum age:
N/A
Maximum age:
N/A
Lead sponsor:
Agency:
AVM Biotechnology Inc
Agency class:
Industry
Source:
AVM Biotechnology Inc
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05974410
