GlioblastomaNCT05974410
Expanded Access to Immunomodulatory AVM0703 for Solid Tumor and Blood Cancer Patients
A study testing AVM0703, Hydrocortisone and Proton pump inhibitor in people with Glioblastoma and Squamous Cell Carcinoma, run by AVM Biotechnology Inc.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Glioblastoma, Squamous Cell Carcinoma, Hodgkin Lymphoma
- What is being tested?
- AVM0703, Hydrocortisone and Proton pump inhibitor
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Who may be able to join
- -
Who cannot join
- -
Trial locations and contacts
No sites are listed yet.
About this study
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
- Being tested
- AVM0703, Hydrocortisone, Proton pump inhibitor
- Medical subject headings
- Glioblastoma, Carcinoma, Squamous Cell, Hodgkin Disease, Lymphoma, Non-Hodgkin, Breast Neoplasms, Prostatic Neoplasms, Stomach Neoplasms, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AVM0703Drug
small molecule immunomodulatory drug
HydrocortisoneDrug
physiologic circadian glucocorticoid
Proton pump inhibitorDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- AVM Biotechnology Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Edward Loniewski, D.O., Study director, AVM Biotechnology Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05974410
- Sponsor's protocol ID
- AVM0703-EAP
- Status last verified
- Oct 2026
- First submitted
- 26 Jul 2023
- Last updated
- 2 Nov 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanded Access to Immunomodulatory AVM0703 for Solid Tumor and Blood Cancer Patients
- ClinicalTrials.gov ID
- NCT05974410
- Acronym / sponsor ID
- AVM0703-EAP
- Conditions
- Glioblastoma, Squamous Cell Carcinoma, Hodgkin Lymphoma, Non-hodgkin Lymphoma, Breast Cancer, Prostate Cancer
- Study type
- Expanded access
- Recruitment status
- Available
- Lead sponsor
- AVM Biotechnology IncIndustry (pharma, biotech, devices)
- First posted
- 3 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- -
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AVM0703small molecule immunomodulatory drug | Drug | – |
| Hydrocortisonephysiologic circadian glucocorticoid | Drug | – |
| Proton pump inhibitor | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edward Loniewski, D.O. study director
AVM Biotechnology Inc
Questions about this trial
What is this clinical trial studying?
A study testing AVM0703, Hydrocortisone and Proton pump inhibitor in people with Glioblastoma and Squamous Cell Carcinoma, run by AVM Biotechnology Inc.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mia Lor (12062607770, mlor@avmbiotech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.