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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 belowSelect...
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:Select...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
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 moreOther 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.
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are allergic to substances that are similar to BMX-001.My cancer is either lung, breast, skin (melanoma), or kidney cancer.I can stop taking certain medications 7 days before starting the trial, if my doctor agrees.I am not pregnant and willing to use birth control during the study due to risks.I have had whole brain radiation therapy before.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.I need 3 or more medications to control my high blood pressure.I am not on medication that could dangerously lower my blood pressure.I have fainted in the last 6 months.I have cancer that has spread to the lining of my brain and spinal cord.My heart's electrical cycle is longer than normal.I am 18 years old or older.I have more than 5 untreated brain lesions, with at least one larger than 0.5cm.I have been examined by a cancer specialist within the last 2 weeks.I am scheduled for whole brain radiation therapy with a specific dose.I am mostly able to care for myself.Women who could become pregnant need to have a negative pregnancy test within 48 hours before starting the study medication.I have not needed IV antibiotics for an infection in the last 7 days.I am willing to follow the study's procedures and complete all required tests and questionnaires.I had surgery or targeted radiation for brain metastases over a month ago.I have risk factors for a rare heart rhythm condition (like heart failure or low potassium).
Research Study Groups:
This trial has the following groups:- Group 1: WBRT + BMX-001
- Group 2: Whole Brain Radiation Therapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.