35 Participants Needed

BMX-001 + Radiotherapy for Brain Metastases

Recruiting at 3 trial locations
SP
Overseen BySara Penchev
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: BioMimetix JV, LLC
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, a new medicine, in patients with multiple brain metastases receiving whole brain radiation therapy. BMX-001 aims to protect healthy brain tissue from radiation damage and enhance the treatment's effectiveness against tumors.

Do I need to stop my current medications for the trial?

The trial protocol mentions that if you are taking any prohibited medications, you may need to stop them at least 7 days before the first dose of BMX-001, but this is at the discretion of the treating physician. It's best to discuss your current medications with the trial team to see if any adjustments are needed.

How does the BMX-001 + Radiotherapy treatment for brain metastases differ from other treatments?

The BMX-001 + Radiotherapy treatment is unique because it combines a novel agent, BMX-001, with radiotherapy, potentially enhancing the effectiveness of radiation by protecting normal brain tissue while targeting cancer cells. This approach may offer a new way to improve outcomes for patients with brain metastases, compared to traditional treatments like whole-brain irradiation or stereotactic radiosurgery alone.12345

What data supports the effectiveness of the treatment BMX-001 for brain metastases?

Radiation therapy is a common and effective treatment for brain metastases, often used alone or with other therapies. Combining radiation with new drugs has shown promise in improving outcomes for patients with brain metastases.12567

Who Is on the Research Team?

JK

John Kirkpatrick, MD

Principal Investigator

Duke Cancer Institute

Are You a Good Fit for This Trial?

This trial is for adults over 18 with certain cancers (non-small cell lung, breast, melanoma, or renal cell) that have spread to the brain. They must be fit enough for radiotherapy and not previously treated with specific surgeries or radiosurgery. Pregnant women and those unable to use contraception are excluded.

Inclusion Criteria

My cancer is either lung, breast, skin (melanoma), or kidney cancer.
Your hemoglobin level is at least 9.0 g/dl, your ANC (a type of white blood cell) count is at least 1,500 cells/µl, and your platelet count is at least 125,000 cells/µl.
Your blood tests show that your creatinine, SGOT, and bilirubin levels are within a certain range.
See 9 more

Exclusion Criteria

You are allergic to substances that are similar to BMX-001.
Women who are breast feeding
I can stop taking certain medications 7 days before starting the trial, if my doctor agrees.
See 10 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Safety Lead-In

Initial safety lead-in phase with 5 patients to assess safety of BMX-001 in combination with WBRT

19 days
Multiple visits for treatment and monitoring

Randomized Treatment

Randomized Phase 2 trial where half of the 64 patients receive BMX-001 with WBRT and half receive WBRT alone

19 days
Multiple visits for treatment and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, including neurocognition and survival assessments

1 year
Regular follow-up visits every 3 months

What Are the Treatments Tested in This Trial?

Interventions

  • BMX-001
Trial Overview The study tests BMX-001 in patients undergoing whole-brain radiation therapy for multiple brain metastases. It starts with a safety phase for 5 patients followed by a randomized test on 64 more to see if BMX-001 protects healthy tissue and helps control tumor growth.
How Is the Trial Designed?
2Treatment groups
Active Control
Group I: WBRT + BMX-001Active Control2 Interventions
Group II: Whole Brain Radiation TherapyActive Control1 Intervention

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+

Citations

The management of brain metastases in non-small cell lung cancer. [2022]
Modern Radiation Therapy for the Management of Brain Metastases From Non-Small Cell Lung Cancer: Current Approaches and Future Directions. [2021]
Effect of Postoperative Radiotherapy for Brain Metastases: An Analysis. [2019]
Use of palliative radiotherapy in brain and bone metastases (VARA II study). [2021]
Efficacy of apatinib+radiotherapy vs radiotherapy alone in patients with advanced multiline therapy failure for non small cell lung cancer with brain metastasis. [2023]
Review of the diagnosis and treatment of brain metastases. [2022]
Systemic chemotherapy after cranial irradiation in patients with brain metastases from non-small cell lung cancer: a retrospective study. [2009]
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