BMX-001 for Head and Neck Cancer

Recruiting at 54 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: NRG Oncology

Must be taking: Cisplatin

Must not be taking: Nitrates, Cytochrome P450 inducers

Disqualifiers: Metastatic disease, Cardiovascular disease, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 6

98 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to determine if adding BMX-001, a protective agent, to usual care can more effectively reduce painful mouth sores in individuals undergoing chemoradiation for head and neck cancer. BMX-001 protects healthy cells from damage during treatment. Participants will receive either BMX-001 or a placebo, along with standard mouth rinses and pain medications. The trial seeks individuals scheduled for radiation and cisplatin chemotherapy for head and neck cancer, who have visible, assessable cancer, and are experiencing challenges like mouth sores. As a Phase 2 trial, this research measures how well BMX-001 works in an initial, smaller group of participants.

Do I have to stop taking my current medications for the BMX-001 trial?

The trial does not specify if you need to stop taking your current medications, but it does prohibit certain drugs that might lower blood pressure or affect the liver enzyme cytochrome P450. It's best to discuss your current medications with the trial team to see if any adjustments are needed.

Is there any evidence suggesting that BMX-001 is likely to be safe for humans?

Research has shown that BMX-001 is generally safe for people. In earlier studies, BMX-001 was combined with radiation and chemotherapy for head and neck cancer. These studies found that BMX-001 did not cause skin or eye irritation and did not alter heart rate or blood pressure.

Another study demonstrated that using BMX-001 with radiation therapy was safe, even at high doses. Some patients experienced additional symptoms, but these were typical for cancer treatments. This suggests that BMX-001 could safely complement regular cancer care, helping to reduce side effects without introducing significant new risks. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for head and neck cancer?

Researchers are excited about BMX-001 for head and neck cancer because it offers a novel approach compared to traditional treatments. While standard care often involves chemotherapy with cisplatin and radiation therapy, BMX-001 works by potentially reducing the harmful side effects of these treatments. BMX-001 is an antioxidant, which means it might protect healthy cells from the damage typically caused by radiation and chemotherapy. This could lead to better quality of life during treatment and allow patients to tolerate higher doses of standard therapies, possibly improving overall outcomes.

What evidence suggests that BMX-001 might be an effective treatment for oral mucositis in head and neck cancer?

Research shows that BMX-001, which participants in this trial may receive, might help reduce oral mucositis, a painful side effect of cancer treatment for head and neck cancer. BMX-001 neutralizes harmful substances in the body, protecting important parts like DNA. This protection might reduce harm to healthy tissues during cancer treatment. Some early studies suggest that adding BMX-001 to regular care could be more effective than usual treatments alone in reducing mouth sores and inflammation caused by cancer treatment. This promising approach could lead to less pain and make swallowing easier for patients. ^{1 3 6 7 8}

Who Is on the Research Team?

David M Brizel

Principal Investigator

NRG Oncology

Are You a Good Fit for This Trial?

This trial is for adults with squamous cell carcinoma of the oropharynx, larynx, hypopharynx, nasopharynx, or oral cavity who are set to receive radiation and cisplatin chemotherapy. They must not have metastatic disease or be undergoing treatment for another unrelated cancer (with some exceptions). A good performance status and having at least two oral subsites receiving significant radiation are also required.

Inclusion Criteria

I am 18 years old or older.

My cancer is confirmed to be in my throat, mouth, or related areas.

My current diagnosis does not show any signs of cancer spread.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Chemoradiation Treatment

Participants receive cisplatin and undergo image-guided intensity-modulated radiation therapy for 7 weeks. In addition to usual symptom management, patients receive either BMX-001 or placebo subcutaneously.

7 weeks

5 visits per week (in-person)

Post-Treatment Monitoring

Participants are monitored for severe oral mucositis and other side effects, with assessments at 4, 6, 8, and 12 weeks after completion of treatment.

12 weeks

Follow-up

Participants are monitored for progression-free survival, overall survival, and other long-term outcomes.

24 months

Follow-up visits at 1, 2, 3, 6, 12, and 24 months

What Are the Treatments Tested in This Trial?

Interventions

• BMX-001

Trial Overview The trial tests if adding BMX-001 to standard symptom management reduces mouth sores caused by chemoradiation better than usual care alone in head and neck cancer patients. It involves comparing the effects of a radioprotector drug versus a placebo alongside various imaging techniques and questionnaires.

How Is the Trial Designed?

Group I: Arm 2 (BMX-001) Experimental Treatment 9 Interventions

Patients receive cisplatin QW or Q3W and undergo image-guided intensity-modulated radiation therapy QD 5 days per week for 7 weeks per SOC. In addition to usual symptom management, patients receive BMX-001 SC as early as 96 hours and no later than one hour prior to their first dose of radiation therapy, and as early as 96 hours and no later than 48 hours prior to first dose of cisplatin. Patients then receive BMX-001 SC BIW for 8 weeks (16 doses). Patients also undergo CT and/or MRI on study and may optionally undergo collection of blood, serum, and/or plasma throughout the study.

Group II: Arm 1 (placebo) Placebo Group 9 Interventions

Patients receive cisplatin QW or Q3W and undergo image-guided intensity-modulated radiation therapy QD 5 days per week for 7 weeks per SOC. In addition to usual symptom management, patients receive placebo SC as early as 96 hours and no later than one hour prior to their first dose of radiation therapy, and as early as 96 hours and no later than 48 hours prior to first dose of cisplatin. Patients then receive placebo SC BIW for 8 weeks (16 doses). Patients also undergo CT and/or MRI on study and may optionally undergo collection of blood, serum, and/or plasma throughout the study.

Who Is Running the Clinical Trial?

NRG Oncology

Lead Sponsor

Trials

242

Recruited

105,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S0360301625029621

Patient-Reported Outcomes from a Phase 1-2 Trial of ... Patients treated with BMX-001 and CRT for HNSCC experienced the greatest symptom burden in physical, functional, and head and neck cancer-specific domains. On ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06532279

NCT06532279 | Testing the Addition of the Drug BMX-001, ... This phase II trial compares the effectiveness of adding BMX-001 to usual symptom management versus usual symptom management alone for reducing oral ...

3. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2024-03906

Testing the Addition of the Drug BMX-001, a ... This phase II trial compares the effectiveness of adding BMX-001 to usual symptom management versus usual symptom management alone for reducing oral ...

4. nrgoncology.org nrgoncology.org/Home/News/Post/adding-bmx-001-to-the-usual-chemoradiation-therapy-for-patients-with-head-and-neck-cancer-nrg-cc013

Adding BMX-001 to the Usual Chemoradiation Therapy for ... This phase 2 trial will compare the incidence of severe oral mucositis (SOM) between BMX-001 and placebo.

5. trialx.com trialx.com/clinical-trials/listings/299358/testing-the-addition-of-the-drug-bmx-001-a-radioprotector-or-a-placebo-to-the-usual-chemoradiation-therapy-for-patients-with-head-and-neck-cancer/

Testing the Addition of the Drug BMX-001, a ... This phase II trial compares the effectiveness of adding BMX-001 to usual symptom management versus usual symptom management alone for reducing ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04607642

Trial of BMX-001 or Placebo in Head and Neck Cancer ... This will be a randomized, placebo-controlled Phase 2 clinical trial to study the effects of BMX-001 (14 mg/subject biw) + radiation therapy + cisplatin against ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/27098749/

Nonclinical Safety and Toxicokinetics of MnTnBuOE-2- ... In additional GLP studies, BMX-001 was not irritating to the skin or eye and caused no changes in cardiac rate or rhythm or blood pressure.

8. redjournal.org redjournal.org/article/S0360-3016(21)01195-0/fulltext

A Phase 1-2 Trial of Concurrent Radiation Therapy ... CRT and 2x/week BMX-001 was safe in HNSCC at the highest dose tested. Promising rates of severe OM and xerostomia justify further investigation ...