A Phase 1 interventional study of M032 (NSC 733972) in Recurrent Glioblastoma Multiforme, Progressive Glioblastoma Multiforme and Anaplastic Astrocytoma or Gliosarcoma, sponsored by University of Alabama at Birmingham. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by University of Alabama at Birmingham · Phase 1, Interventional, and Treatment
To determine the safety and tolerability of the maximum dose for laboratory engineered Herpes Simplex Virus-1 in patients who would not be eligible for surgical resection of recurrent glioma To determine the safety and tolerability of the maximum dose for laboratory engineered Herpes Simples Virus-1 in patients who would benefit from surgical resection of recurrent glioma
M032 is a second-generation oncolytic herpes simplex virus (oHSV) that is conditionally replication competent; that is, similar to G207, a first generation oHSV, it can replicate in tumor cells, but not in normal cells, thus killing the tumor cells directly through this process. Replication of M032 in the tumor itself not only kills the infected tumor cells, but causes the tumor cell to act as a factory to produce new virus. These virus particles are released as the tumor cell dies, and can then proceed to infect other tumor cells in the vicinity, and continue the process of tumor kill. In addition to this direct oncolytic activity, the virus carries a therapeutic payload--acting as a gene therapy vector, too--and causes the tumor cell to synthesize and secrete an immunity-stimulating protein called Interleukin-12 (IL-12) before it is killed. This IL-12 is released and promotes an immune response against surviving tumor cells, which increases the antitumor effect of the therapy. The IL-12 that is expressed can also produce an anti-angiogenic effect, by interfering with the production of new tumor blood vessels necessary to allow tumor growth. Anti-angiogenic therapies potentially starve the tumor of necessary oxygen and nutrients. Thus, the M032 oHSV produces three different potential mechanisms for antitumor effects. The virus has also been genetically-engineered to minimize the production of any toxic effects for the patient receiving the therapy.
2,132 studies on the registry are indexed under Glioblastoma; 464 are open to participants now.
This study's enrollment of 29 is below the median of 36 across 1,753 interventional studies indexed under Glioblastoma.
Browse Glioblastoma studies →University of Alabama at Birmingham is the lead sponsor of 1,421 studies on the registry; 277 are open to participants now.
Of its 164 completed or terminated interventional studies of FDA-regulated products, 130 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients must have normal organ and marrow function as defined below:
Exclusion Criteria
Excluded patient groups
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Leptomeningeal disease
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
single dose of HSV-1 (M032) infused through catheters into region(s) of tumor defined by MRI
Biological: M032 (NSC 733972)
A single dose of HSV-1 (M032) infused through catheters into region(s) of tumor defined by MRI
Maximum Tolerated Dose (MTD) of M032
Time frame: baseline to12 months
Time to Progression Assessment
Time frame: baseline to 12 months
The Time of Survival Assessment
Time frame: baseline to 12 months
The Time of Biologic Assessment
Time frame: baseline to 12 months
| Milestone | 10^5 Single Dose of HSV-1 (M032) | 10^6 Single Dose of HSV-1 (M032) | 10^7 Single Dose of HSV-1 (M032) | 10^7.5 Single Dose of HSV-1 (M032) | 10^8 Single Dose of HSV-1 (M032) | 10^8.5 Single Dose of HSV-1 (M032) | 10^9 Single Dose of HSV-1 (M032) | Screen Fails |
|---|---|---|---|---|---|---|---|---|
| Started | 4 | 1 | 1 | 2 | 6 | 1 | 6 | 8 |
| Completed | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 |
| Not completed | 4 | 1 | 1 | 2 | 6 | 0 | 5 | 8 |
| Withdrew: Death | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Withdrawal by subject | 3 | 1 | 1 | 2 | 6 | 0 | 5 | 0 |
| Withdrew: Screen fail | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 8 |
| plaque-forming units (PFU) | Single Dose of HSV-1 (M032) |
|---|---|
| Maximum Tolerated Dose (MTD) of M032 | 1000000000 |
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Collected over 12 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 10^5 Single Dose of HSV-1 (M032) | 4/4 (100%) | 0/4 (0%) | 4/4 (100%) |
| 10^6 Single Dose of HSV-1 (M032) | 1/1 (100%) | 0/1 (0%) | 0/1 (0%) |
| 10^7 Single Dose of HSV-1 (M032) | 1/1 (100%) | 0/1 (0%) | 0/1 (0%) |
| 10^7.5 Single Dose of HSV-1 (M032) | 2/2 (100%) | 1/2 (50%) | 2/2 (100%) |
| 10^8 Single Dose of HSV-1 (M032) | 6/6 (100%) | 1/6 (16.7%) | 6/6 (100%) |
| 10^8.5 Single Dose of HSV-1 (M032) | 1/1 (100%) | 1/1 (100%) | 1/1 (100%) |
| 10^9 Single Dose of HSV-1 (M032) | 4/6 (66.7%) | 2/6 (33.3%) | 6/6 (100%) |
| Event | 10^5 Single Dose of HSV-1 (M032) | 10^6 Single Dose of HSV-1 (M032) | 10^7 Single Dose of HSV-1 (M032) | 10^7.5 Single Dose of HSV-1 (M032) | 10^8 Single Dose of HSV-1 (M032) | 10^8.5 Single Dose of HSV-1 (M032) | 10^9 Single Dose of HSV-1 (M032) |
|---|---|---|---|---|---|---|---|
| HypertensionVascular disorders | 0/4 | 0/1 | 0/1 | 0/2 | 0/6 | 1/1 | 0/6 |
| Surgical wound not healingSurgical and medical procedures | 0/4 | 0/1 | 0/1 | 0/2 | 0/6 | 1/1 | 0/6 |
| FatigueGeneral disorders | 0/4 | 0/1 | 0/1 | 1/2 | 0/6 | 0/1 | 0/6 |
| HeadacheGeneral disorders | 0/4 | 0/1 | 0/1 | 1/2 | 0/6 | 0/1 | 0/6 |
| AspirationRespiratory, thoracic and mediastinal disorders | 0/4 | 0/1 | 0/1 | 0/2 | 1/6 | 0/1 | 0/6 |
| Cerebral HerniationNervous system disorders | 0/4 | 0/1 | 0/1 | 0/2 | 1/6 | 0/1 | 0/6 |
| ComaNervous system disorders | 0/4 | 0/1 | 0/1 | 0/2 | 1/6 | 0/1 | 0/6 |
| HyponatremiaVascular disorders | 0/4 | 0/1 | 0/1 | 0/2 | 0/6 | 0/1 | 1/6 |
| Intracranial Infection - intraduralNervous system disorders | 0/4 | 0/1 | 0/1 | 0/2 | 1/6 | 0/1 | 0/6 |
| Left HemiplegiaNervous system disorders | 0/4 | 0/1 | 0/1 | 0/2 | 1/6 | 0/1 | 0/6 |
| Event | 10^5 Single Dose of HSV-1 (M032) | 10^6 Single Dose of HSV-1 (M032) | 10^7 Single Dose of HSV-1 (M032) | 10^7.5 Single Dose of HSV-1 (M032) | 10^8 Single Dose of HSV-1 (M032) | 10^8.5 Single Dose of HSV-1 (M032) | 10^9 Single Dose of HSV-1 (M032) |
|---|---|---|---|---|---|---|---|
| Ear InfectionEar and labyrinth disorders | 0/4 | 0/1 | 0/1 | 0/2 | 0/6 | 1/1 | 0/6 |
| Nausea & vomitingGastrointestinal disorders | 0/4 | 0/1 | 0/1 | 0/2 | 1/6 | 1/1 | 0/6 |
| Gait DisturbanceNervous system disorders | 3/4 | 0/1 | 0/1 | 0/2 | 0/6 | 0/1 | 1/6 |
| Blurred VisionEye disorders | 0/4 | 0/1 | 0/1 | 1/2 | 0/6 | 0/1 | 0/6 |
| DiarrheaGastrointestinal disorders | 0/4 | 0/1 | 0/1 | 1/2 | 0/6 | 0/1 | 0/6 |
| EpistaxisRespiratory, thoracic and mediastinal disorders | 0/4 | 0/1 | 0/1 | 1/2 | 0/6 | 0/1 | 0/6 |
| FallInjury, poisoning and procedural complications | 1/4 | 0/1 | 0/1 | 1/2 | 3/6 | 0/1 | 2/6 |
| Left arm & Right leg painGeneral disorders | 0/4 | 0/1 | 0/1 | 1/2 | 0/6 | 0/1 | 0/6 |
| Pain & swelling L foot/ankle gout flare upGeneral disorders | 0/4 | 0/1 | 0/1 | 1/2 | 0/6 | 0/1 | 0/6 |
| Rash to armsSkin and subcutaneous tissue disorders | 0/4 | 0/1 | 0/1 | 1/2 | 0/6 | 0/1 | 0/6 |
| Age, Categorical(Participants) | 10^5 Single Dose of HSV-1 (M032) | 10^6 Single Dose of HSV-1 (M032) | 10^7 Single Dose of HSV-1 (M032) | 10^7.5 Single Dose of HSV-1 (M032) | 10^8 Single Dose of HSV-1 (M032) | 10^8.5 Single Dose of HSV-1 (M032) | 10^9 Single Dose of HSV-1 (M032) | Screen Fails | Total |
|---|---|---|---|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 4 | 1 | 1 | 2 | 5 | 1 | 5 | 7 | 26 |
| >=65 years | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 1 | 3 |
| Age, Continuous(years) | 10^5 Single Dose of HSV-1 (M032) | 10^6 Single Dose of HSV-1 (M032) | 10^7 Single Dose of HSV-1 (M032) | 10^7.5 Single Dose of HSV-1 (M032) | 10^8 Single Dose of HSV-1 (M032) | 10^8.5 Single Dose of HSV-1 (M032) | 10^9 Single Dose of HSV-1 (M032) | Screen Fails | Total |
|---|---|---|---|---|---|---|---|---|---|
| Mean | 40 ± 48.45 | 39 ± 48.45 | 56 ± 48.45 | 42.5 ± 48.45 | 52.67 ± 48.45 | 56 ± 48.45 | 48.83 ± 48.45 | 50 ± 48.5 | 49.07 ± 48.45 |
| Sex: Female, Male(Participants) | 10^5 Single Dose of HSV-1 (M032) | 10^6 Single Dose of HSV-1 (M032) | 10^7 Single Dose of HSV-1 (M032) | 10^7.5 Single Dose of HSV-1 (M032) | 10^8 Single Dose of HSV-1 (M032) | 10^8.5 Single Dose of HSV-1 (M032) | 10^9 Single Dose of HSV-1 (M032) | Screen Fails | Total |
|---|---|---|---|---|---|---|---|---|---|
| Female | 2 | 0 | 1 | 0 | 1 | 1 | 0 | 2 | 7 |
| Male | 2 | 1 | 0 | 2 | 5 | 0 | 6 | 6 | 22 |
| Race (NIH/OMB)(Participants) | 10^5 Single Dose of HSV-1 (M032) | 10^6 Single Dose of HSV-1 (M032) | 10^7 Single Dose of HSV-1 (M032) | 10^7.5 Single Dose of HSV-1 (M032) | 10^8 Single Dose of HSV-1 (M032) | 10^8.5 Single Dose of HSV-1 (M032) | 10^9 Single Dose of HSV-1 (M032) | Screen Fails | Total |
|---|---|---|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| White | 4 | 1 | 1 | 2 | 6 | 1 | 6 | 8 | 29 |
| More than one race | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | 10^5 Single Dose of HSV-1 (M032) | 10^6 Single Dose of HSV-1 (M032) | 10^7 Single Dose of HSV-1 (M032) | 10^7.5 Single Dose of HSV-1 (M032) | 10^8 Single Dose of HSV-1 (M032) | 10^8.5 Single Dose of HSV-1 (M032) | 10^9 Single Dose of HSV-1 (M032) | Screen Fails | Total |
|---|---|---|---|---|---|---|---|---|---|
| United States | 4 | 1 | 1 | 2 | 6 | 1 | 6 | 8 | 29 |
PDFs hosted by the registry, ClinicalTrials.gov.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: IL-12-expressing HSV-1 NSC 733972
University of Alabama at Birmingham →