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BMX-001 + Radiotherapy for Brain Metastases

Phase 1 & 2
Waitlist Available
Led By John Kirkpatrick, MD
Research Sponsored by BioMimetix JV, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects must have histologically confirmed diagnosis of a non-small cell lung cancer, breast cancer, melanoma or renal cell cancer primary
Plan to be treated with WBRT to a dose of 30 Gy in 10 fractions
Must not have
Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic
Prior whole brain radiation therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
No Placebo-Only Group

Summary

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.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects of BMX-001 aren't detailed here but may include typical reactions related to new pharmaceuticals such as allergic responses, issues from drug interactions, or complications from underlying health conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer is either lung, breast, skin (melanoma), or kidney cancer.
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I am scheduled for whole brain radiation therapy with a specific dose.
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I am 18 years old or older.
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I am mostly able to care for myself.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not pregnant and willing to use birth control during the study due to risks.
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I have had whole brain radiation therapy before.
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I need 3 or more medications to control my high blood pressure.
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I have fainted in the last 6 months.
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I have cancer that has spread to the lining of my brain and spinal cord.
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My heart's electrical cycle is longer than normal.
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I have not needed IV antibiotics for an infection in the last 7 days.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Assess safety and tolerability of WBRT + BMX-001 through proportion of patients who experience grade 4 or 5 study drug related adverse events.
Compare neurocognition in WBRT + BMX-001 vs. WBRT alone using cumulative score of HVLT-R, TMT A&B and COWA over time.
Secondary study objectives
Compare distant brain failure rate in WBRT + BMX-001 vs WBRT alone
Compare local recurrence rate in WBRT + BMX-001 vs WBRT alone
Compare rate of neurologic death in WBRT + BMX-001 vs WBRT alone
+1 more
Other study objectives
Compare QoL in WBRT + BMX-001 vs WBRT alone
Compare rate of radionecrosis in WBRT + BMX-001 vs WBRT alone

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Active Control
Group I: WBRT + BMX-001Active Control2 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 TherapyActive Control1 Intervention
Whole brain radiation therapy per standard of care.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for brain metastases include whole-brain radiotherapy (WBRT), stereotactic radiosurgery (SRS), and systemic therapies such as targeted agents and immunotherapy. WBRT and SRS work by delivering high doses of radiation to destroy cancer cells, but they can also damage normal brain tissue. BMX-001, a novel treatment under investigation, aims to protect normal tissues from radiation-induced injury while enhancing the inhibition of tumor growth. This dual mechanism is crucial for brain metastases patients as it potentially reduces the side effects of radiation therapy, preserving cognitive function and quality of life, while effectively targeting and controlling tumor progression.
The influence of the blood-brain barrier in the treatment of brain tumours.Treatment of brain metastases in the modern genomic era.Hypoxia in Gliomas: Opening Therapeutical Opportunities Using a Mathematical-Based Approach.

Find a Location

Who is running the clinical trial?

BioMimetix JV, LLCLead Sponsor
10 Previous Clinical Trials
662 Total Patients Enrolled
Duke Cancer InstituteOTHER
16 Previous Clinical Trials
2,998 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,938 Previous Clinical Trials
41,023,135 Total Patients Enrolled
John Kirkpatrick, MDPrincipal InvestigatorDuke Cancer Institute
2 Previous Clinical Trials
13 Total Patients Enrolled

Media Library

WBRT + BMX-001 Clinical Trial Eligibility Overview. Trial Name: NCT03608020 — Phase 1 & 2
Brain Cancer Research Study Groups: WBRT + BMX-001, Whole Brain Radiation Therapy
Brain Cancer Clinical Trial 2023: WBRT + BMX-001 Highlights & Side Effects. Trial Name: NCT03608020 — Phase 1 & 2
WBRT + BMX-001 2023 Treatment Timeline for Medical Study. Trial Name: NCT03608020 — Phase 1 & 2
~5 spots leftby Dec 2025