177 Participants Needed

BMX-001 + Chemoradiation for Brain Cancer

(BMX-HGG Trial)

Recruiting in Columbus (<10 mi)
+8 other locations
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: BioMimetix JV, LLC
Must be taking: Temozolomide
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

KP

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
See 7 more

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.
See 14 more

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?
3Treatment groups
Experimental Treatment
Active Control
Group I: Phase 2 Arm A: Radiation Therapy, TMZ and BMX-001Experimental Treatment3 Interventions
Group II: Phase 1Experimental Treatment3 Interventions
Group III: Phase 2 Arm B: Radiation Therapy and TMZActive Control2 Interventions

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

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Approved in European Union as Radiation Therapy for:
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Approved in United States as Radiation Therapy for:
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Approved in Canada as Radiation Therapy for:
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Approved in Japan as Radiation Therapy for:
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Approved in China as Radiation Therapy for:
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Approved in Switzerland as Radiation Therapy for:

Find a Clinic Near You

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+
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