MBM-02 (Tempol) for the Treatment of Glioblastoma Multiforme (GBM)

NCT04874506 | Unknown Phase 2 DMC FDA Drug

• 1 other identifier: MBI-10-01
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

MBM-02 (Tempol) is an HIF-1 and HIF-2 inhibitor that is being tested as an addition to standard of care treatment that includes radiotherapy and TMZ. MBM-02's ability to increase progression free survival and decrease side effects of TMZ and radiotherapy treatment will be assessed.

Conditions

Glioblastoma; Glioblastoma Multiforme

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival

  Clinical efficacy as measured by progression-free survival rate at six months (PFS-6). Progression-free survival will be defined as the number of days from the date of first dose to the date of earliest disease progression based on RANO criteria.

  baseline to 6 months

Secondary Outcomes (3)

• Overall Survival

  baseline to 24 months

• Thrombocytopenia

  baseline to 12 months

• Neutropenia

  baseline to 12 months

Other Outcomes (1)

• Radiation Necrosis

  baseline to 3 months post-RT

Study Arms (4)

Cohort 1

EXPERIMENTAL

Cohort 1 will receive standard of care concomitantly with1000 mg/day of MBM-02. Patients will receive standard of care treatment for newly diagnosed Glioblastoma multiforme consisting of four sequential periods: 1. 1 week run-in with MBM-02 prior to radiotherapy; 2. 6 weeks of radiotherapy and concomitant temozolomide; 3. 4 weeks of rest post-radiotherapy and concomitant temozolomide; and 4. Adjuvant temozolomide treatment post 4-week rest period. Patients will be administered daily MBM-02 during all four sequential periods.

Drug: MBM-02

Cohort 2

EXPERIMENTAL

Cohort 2 will receive standard of care concomitantly with1200 mg/day of MBM-02. Patients will receive standard of care treatment for newly diagnosed Glioblastoma multiforme consisting of four sequential periods: 1. 1 week run-in with MBM-02 prior to radiotherapy; 2. 6 weeks of radiotherapy and concomitant temozolomide; 3. 4 weeks of rest post-radiotherapy and concomitant temozolomide; and 4. Adjuvant temozolomide treatment post 4-week rest period. Patients will be administered daily MBM-02 during all four sequential periods.

Drug: MBM-02

Cohort 3

EXPERIMENTAL

Cohort 2 will receive standard of care concomitantly with1400 mg/day of MBM-02. Patients will receive standard of care treatment for newly diagnosed Glioblastoma multiforme consisting of four sequential periods: 1. 1 week run-in with MBM-02 prior to radiotherapy; 2. 6 weeks of radiotherapy and concomitant temozolomide; 3. 4 weeks of rest post-radiotherapy and concomitant temozolomide; and 4. Adjuvant temozolomide treatment post 4-week rest period. Patients will be administered daily MBM-02 during all four sequential periods.

Drug: MBM-02

Cohort 4

EXPERIMENTAL

Cohort 2 will receive standard of care concomitantly with1400 mg/day of MBM-02. Patients will receive standard of care treatment for newly diagnosed Glioblastoma multiforme consisting of four sequential periods: 1. 1 week run-in with MBM-02 prior to radiotherapy; 2. 6 weeks of radiotherapy and concomitant temozolomide; 3. 4 weeks of rest post-radiotherapy and concomitant temozolomide; and 4. Adjuvant temozolomide treatment post 4-week rest period. Patients will be administered daily MBM-02 during all four sequential periods.

Drug: MBM-02

Interventions

MBM-02 DRUG

Study drug will be administered orally using the capsule formulation (200 mg). The study drug will be administered 7 days a week for the entire treatment period.

Also known as: Tempol; 4-hydroxy-tempo; 4-hydroxy-2,2,6,6-tetramethylpiperidine-1-oxyl

Cohort 1; Cohort 2; Cohort 3; Cohort 4

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be \> 35 and ≤ 75 years of age;
• Be newly diagnosed with glioblastoma multiforme within 4 weeks of open biopsy/resection;
• Be histologically confirmed to have definitive GBM by partial or complete surgical resection (i.e. not by biopsy only) within 4 weeks prior to MBM-02 administration;
• Have recovered from the effects of surgery, post-operative infection, and other complications before study registration;
• Have a diagnostic contrast-enhanced MRI or CT scan of the brain performed preoperatively and postoperatively prior to the initiation of radiotherapy, within 28 days prior to MBM-02 administration;
• If female and of child bearing potential, must be using an effective birth-control method as described in section 3.5;
• If a male with a female partner of child bearing potential, adequate methods of contraception must be employed as described in section 3.5.
• If male, no sperm donation for 90 days until after the conclusion of the study;
• Be properly informed of the nature and risks of the clinical investigation, comply with all clinical investigation-related procedures, and sign an Informed Consent Form prior to entering the clinical investigation;
• Be able to participate for the full term of the clinical investigation;
• Have a Karnofsky performance status of \>70;
• Have a life expectancy ≥ 6 months; and
• Have adequate baseline organ function (hematologic, liver, renal, nutritional and metabolic):
• Hematology:
• Absolute neutrophil count (ANC) ≥1.5 Hemoglobin ≥ 10 g/dL Platelets ≥ 100,000 per microliter of blood

You may not qualify if:

• Evidence of recurrent GBM or metastases detected outside of the cranial vault;
• Patients with histone H3 K27M mutation or gliosarcoma;
• Patients using the Optune device during study drug administration;
• Prior cancer diagnosis other than skin basal cell or squamous cell carcinoma (non-metastatic);
• Patients unable to undergo MRI because of non-compatible devices;
• Oxygen dependent chronic obstructive pulmonary disease (COPD);
• Unstable coronary artery disease (CAD);
• Diagnosis of midline diffuse glioma (glioblastoma);
• Insufficient biopsy tissue for full molecular profiling of the tumor;
• Prior radiation or chemotherapy for glioblastoma or glioma;
• Prior radiation for cancer of the head and neck that would result in an overlap of radiation fields;
• Evidence of a significant medical illness, or a psychiatric illness/social situation that would, in the investigator's judgment, make the patient inappropriate for this study;
• Refractory nausea and vomiting, malabsorption, biliary shunt, or significant bowel resection that would preclude adequate absorption of the study drug;
• Have had a recent, serious, non-malignant medical complication that, in the opinion of the investigator, makes the individual unsuitable for study participation;
• Have used an investigational drug within 28 days of the initiation of study treatment;

Sponsors & Collaborators

• Matrix Biomed, Inc.: lead
• MedStar Health: collaborator

Study Sites (1)

Georgetown

Washington D.C., District of Columbia, 20007, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Glioblastoma

Interventions

tempol; TEMPOL-H

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Joseph Watson, M.D.

  Georgetown University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Benji Crane

CONTACT

6264376506; bjcrane@matrixbiomed.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Model Details: Three dosing regimens will be explored and represented by Cohort 1, Cohort 2, and Cohort 3. The first 6 patients (Cohort 1) will begin with a total daily dose (TDD) of 1000 mg of MBM-02.

Study Record Dates

• First Submitted: May 3, 2021
• First Posted: May 5, 2021
• Study Start: June 1, 2021
• Primary Completion: January 1, 2023
• Study Completion: August 1, 2023
• Last Updated: May 5, 2021

Record last verified: 2021-05

Locations

US (1)