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

NCT05974410 | Unknown

• 1 other identifier: AVM0703-EAP
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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

AVM0703 DRUG

small molecule immunomodulatory drug

Hydrocortisone DRUG

physiologic circadian glucocorticoid

Proton pump inhibitor DRUG

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• AVM Biotechnology Inc: lead

MeSH Terms

Conditions

Glioblastoma; Carcinoma, Squamous Cell; Hodgkin Disease; Lymphoma, Non-Hodgkin; Breast Neoplasms; Prostatic Neoplasms; Stomach Neoplasms; Ovarian Neoplasms; Pancreatic Neoplasms; Sarcoma; Neoplasms; Brain Neoplasms

Interventions

Hydrocortisone; Proton Pump Inhibitors

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Carcinoma; Neoplasms, Squamous Cell; Lymphoma; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Neoplasms, Female; Endocrine System Diseases; Gonadal Disorders; Pancreatic Diseases; Neoplasms, Connective and Soft Tissue; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 11-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; 17-Hydroxycorticosteroids; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Edward Loniewski, D.O.

  AVM Biotechnology Inc

  STUDY DIRECTOR

Central Study Contacts

Mia Lor

CONTACT

12062607770; mlor@avmbiotech.com

Theresa A DEISHER, PhD

CONTACT

12068513942; tdeisher@avmbiotech.com

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2023
• First Posted: August 3, 2023
• Last Updated: October 2, 2025

Record last verified: 2025-09