BMX-001 + Radiotherapy for Brain Metastases

Recruiting at 3 trial locations

Overseen By Sara Penchev

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: BioMimetix JV, LLC

Must not be taking: Nitrates, others

Disqualifiers: Hypertension, Pregnancy, Breastfeeding, others

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

Compensation: Varies

Number of Visits: 3

35 Participants Needed

Trial Summary

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.

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. ^{1 2 3 4 5}

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. ^{1 2 3 6 7}

Research Team

John Kirkpatrick, MD

Principal Investigator

Duke Cancer Institute

Eligibility Criteria

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.

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.

Timeline

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

Treatment Details

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.

Participant Groups

Group I: WBRT + BMX-001 Active Control 2 Interventions

Whole brain radiation therapy in combination with BMX-001 (subcutaneous injection of 28 mg loading dose, followed by subsequent 14 mg twice per week for 2 weeks).

Group II: Whole Brain Radiation Therapy Active Control 1 Intervention

Whole brain radiation therapy per standard of care.

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+

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

The management of brain metastases in non-small cell lung cancer. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Modern Radiation Therapy for the Management of Brain Metastases From Non-Small Cell Lung Cancer: Current Approaches and Future Directions. [2021]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Effect of Postoperative Radiotherapy for Brain Metastases: An Analysis. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Use of palliative radiotherapy in brain and bone metastases (VARA II study). [2021]

5. England pubmed.ncbi.nlm.nih.gov

Efficacy of apatinib+radiotherapy vs radiotherapy alone in patients with advanced multiline therapy failure for non small cell lung cancer with brain metastasis. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Review of the diagnosis and treatment of brain metastases. [2022]

7. Ireland pubmed.ncbi.nlm.nih.gov

Systemic chemotherapy after cranial irradiation in patients with brain metastases from non-small cell lung cancer: a retrospective study. [2009]