BMX-001 + Chemoradiation for Brain Cancer

(BMX-HGG Trial)

Recruiting at 8 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: BioMimetix JV, LLC

Must be taking: Temozolomide

Must not be taking: Immuno-suppressive agents

Disqualifiers: Pregnancy, Infection, Cardiovascular disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 17

Duration: 8 weeks

177 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests BMX-001, an injectable drug, added to standard radiation and chemotherapy for newly diagnosed aggressive brain cancer patients. The goal is to see if BMX-001 can improve survival and protect brain function.

Who Is on the Research Team?

Katherine Peters, MD, PhD

Principal Investigator

Duke Cancer Institute

Are You a Good Fit for This Trial?

This trial is for adults over 18 with a recent (within 12 weeks) surgical intervention for high-grade glioma, WHO grade III or IV. They must be ready to start standard radiation and chemotherapy, have good organ function and performance status, agree to use contraception if sexually active, and not have any severe infections or other health conditions that could interfere with the study.

Inclusion Criteria

If sexually active, patients must agree to use appropriate contraceptive measures for the duration of the study and for 12 months afterwards as stated in the informed consent

Hemoglobin ≥ 9.0 g/dl, absolute neutrophil count (ANC) ≥ 1,500 cells/µl, platelets ≥ 125,000 cells/µl

Serum creatinine ≤ 1.5 mg/dl, serum glutamate oxaloacetate transaminase (SGOT) and bilirubin ≤ 1.5 times upper limit of normal

Exclusion Criteria

Severe allergy to contrast agent

Pregnancy or breast-feeding

I have not needed IV antibiotics for an infection in the last 7 days.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive radiation therapy and temozolomide, with BMX-001 administered subcutaneously for 8 weeks

8 weeks

Weekly visits for CBC and CMP

Adjuvant Chemotherapy

Participants transition to adjuvant chemotherapy with temozolomide for 12 cycles

12 months

Every 8 weeks for MRI and cognitive testing

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

Every 8 weeks for MRI and cognitive testing

What Are the Treatments Tested in This Trial?

Interventions

• BMX-001
• Radiation Therapy
• Temozolomide

Trial Overview The trial is testing BMX-001 in combination with standard radiation therapy and temozolomide in patients newly diagnosed with high-grade glioma. The goal is to see if BMX-001 improves survival rates and cognitive functions compared to the standard treatment alone. Patients are randomly assigned to either receive BMX-001 along with chemoradiation or just chemoradiation.

How Is the Trial Designed?

Group I: Phase 2 Arm A: Radiation Therapy, TMZ and BMX-001 Experimental Treatment 3 Interventions

Patients will receive standard of care radiation therapy plus temozolomide (TMZ). BMX-001 will be given by subcutaneous injection with a loading dose of 28 mg/subject given within 4 days prior to initiation of radiation therapy and followed by biweekly maintenance doses at half the loading dose for a total of 8 weeks. A total of 80 subjects will receive BMX-001 in this phase.

Group II: Phase 1 Experimental Treatment 3 Interventions

All subjects enrolled will receive BMX-001 at one of 4 different dose levels. BMX-001 will be given by subcutaneous injection with a loading dose given within 4 days prior to initiation of radiation therapy and followed by biweekly maintenance doses (half the dosing dose) for a total of 8 weeks. Subjects will also undergo standard therapy (radiation therapy plus temozolomide \[TMZ\])

Group III: Phase 2 Arm B: Radiation Therapy and TMZ Active Control 2 Interventions

In this arm, one-half of the study subjects will not receive BMX-001 but will undergo all components of standard therapy (radiation therapy plus temozolomide \[TMZ\]). A total of 80 subjects will be in this study arm.

Radiation Therapy is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

Approved in European Union as Radiation Therapy for:

• Cancer treatment
• Palliative care
• Oropharyngeal cancer
• Breast cancer
• Prostate cancer
• Lung cancer
• Brain tumors

Approved in United States as Radiation Therapy for:

• Cancer treatment
• Palliative care
• Oropharyngeal cancer
• Breast cancer
• Prostate cancer
• Lung cancer
• Brain tumors

Approved in Canada as Radiation Therapy for:

• Cancer treatment
• Palliative care
• Oropharyngeal cancer
• Breast cancer
• Prostate cancer
• Lung cancer
• Brain tumors

Approved in Japan as Radiation Therapy for:

• Cancer treatment
• Palliative care
• Oropharyngeal cancer
• Breast cancer
• Prostate cancer
• Lung cancer
• Brain tumors

Approved in China as Radiation Therapy for:

• Cancer treatment
• Palliative care
• Oropharyngeal cancer
• Breast cancer
• Prostate cancer
• Lung cancer
• Brain tumors

Approved in Switzerland as Radiation Therapy for:

• Cancer treatment
• Palliative care
• Oropharyngeal cancer
• Breast cancer
• Prostate cancer
• Lung cancer
• Brain tumors

Who Is Running the Clinical Trial?

BioMimetix JV, LLC

Lead Sponsor

Trials

11

Recruited

700+

Duke Cancer Institute

Collaborator

Trials

17

Recruited

3,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+