NBM-BMX for Eye Cancer
(NBM-BMX-UM Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial seeks to determine the optimal dose of a new drug, NBM-BMX, for individuals with metastatic uveal melanoma, a type of eye cancer that has spread. Researchers will assess whether NBM-BMX can slow or shrink tumors and monitor any side effects. Participants will take the drug as a capsule twice daily and visit the clinic regularly for check-ups. Individuals diagnosed with metastatic uveal melanoma who have tried other treatments may be suitable for this trial. As a Phase 1, Phase 2 trial, this research aims to understand how the treatment works in people and measure its effectiveness in an initial, smaller group.
Will I have to stop taking my current medications?
You may need to stop taking certain medications before joining the trial. Specifically, you cannot take moderate and strong inhibitors or inducers of CYP2C8, P-gp or BCRP inhibitors, or systemic acid-reducing agents like proton pump inhibitors. If you are on these medications, you should discuss alternatives with your doctor.
Is there any evidence suggesting that NBM-BMX is likely to be safe for humans?
Studies have shown that NBM-BMX is generally well tolerated by patients with advanced solid tumors. Research indicates that a total daily dose of 600 mg of NBM-BMX was safe, as patients did not experience serious side effects that would prevent dose escalation. This study will begin with a lower dose of 200 mg per day, expected to be safe and effective based on previous data.
NBM-BMX targets a protein called HDAC8, involved in the growth of uveal melanoma, a type of eye cancer. The treatment has already been tested in humans, and findings suggest it is generally well tolerated. While side effects are possible, the study is designed to keep them manageable.12345Why do researchers think this study treatment might be promising for eye cancer?
Unlike the standard treatments for eye cancer, which often involve surgery, radiation, or chemotherapy, NBM-BMX is a small molecule inhibitor that specifically targets the HDAC8 pathway. This pathway plays a crucial role in the development and growth of uveal melanoma, a type of eye cancer. Researchers are excited because NBM-BMX has shown promising activity in a metastatic uveal melanoma patient, suggesting it might be highly effective for this disease. Additionally, this treatment is being tested in several dosages to ensure safety and effectiveness, offering a potentially more tailored and less invasive option compared to conventional therapies.
What evidence suggests that NBM-BMX might be an effective treatment for metastatic uveal melanoma?
Research has shown that NBM-BMX, the investigational treatment in this trial, may help treat metastatic uveal melanoma, a type of eye cancer that spreads. Studies have found that this drug targets specific processes involved in tumor growth. The FDA granted NBM-BMX special designations, Fast Track and Orphan Drug, due to its potential benefits. In early tests, patients responded well without serious side effects, suggesting that NBM-BMX might effectively slow down or shrink these tumors. Initial results are promising, but further research is needed to confirm these findings.12367
Are You a Good Fit for This Trial?
Adults over 18 with metastatic uveal melanoma, a type of eye cancer that has spread. They must be relatively active (ECOG ≤ 2), have measurable disease, and could have had any number of prior chemotherapy treatments. Surgery is okay if healed for at least 4 weeks. Those with certain genetic markers need specific prior treatment unless unsuitable.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive NBM-BMX orally twice daily for 28-day cycles until disease progression or intolerable toxicity
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- NBM-BMX
Trial Overview
The trial tests NBM-BMX capsules by Novelwise to determine the optimal dose for treating metastatic uveal melanoma. It assesses side effects, how the body processes the drug, and its impact on tumor size and growth.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
NBM-BMX is a small molecule inhibitor of HDAC8 currently in Phase I testing that has demonstrated activity in a metastatic UM patient. Given the role of the HDAC8 pathway on development and growth of uveal melanoma and the initial clinical activity in the UM setting, there is a high probability that NBM-BMX would have efficacy in this disease In the present Phase Ib/II study, up to four dose levels are planned: * Dose Level 1: 200 mg daily (100 mg BID) * Dose Level 2: 400 mg daily (200 mg BID) * Dose Level 3: 600 mg daily (300 mg BID) * Dose Level 4: 800 mg daily (400 mg BID) A total daily dose of 600 mg (300 mg BID) of the NBM-BMX dry powder formulation has been well tolerated in patients with advanced solid tumors. As three subjects have completed treatment at this dose level without evidence of DLTs, the 200 mg/day dose selected for this trial represents two full dose levels below the highest tolerated dose and is expected to be both safe and pharmacologically active.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Novelwise Pharmaceutical Corporation
Lead Sponsor
Citations
Study Details | NCT07136181 | Evaluation of the Safety, ...
This study is being done to find the best dose of an investigational drug called NBM-BMX for people with metastatic uveal melanoma, a type of eye cancer ...
FDA Grants Fast Track Status to NBM-BMX for Metastatic ...
NBM-BMX targets epigenetic mechanisms in solid tumors, addressing BAP1-associated dysregulation in uveal melanoma progression. The phase 1/2 ...
NBM-BMX Earns FDA Orphan Drug Status for Uveal ...
FDA designates NBM-BMX as an orphan drug for metastatic uveal melanoma, highlighting its potential in treating this aggressive cancer.
HDAC inhibition enhances the in vivo efficacy of MEK ...
As a single agent, MEK inhibition has some activity against uveal melanoma cell lines, and is associated with reduced cell proliferation in vitro (7, 8). In ...
Latest Medical News & Research | Evidence-Based Updates
The study in question reports that the U.S. FDA granted Fast Track Designation to NBM‑BMX, a selective HDAC8 inhibitor, for treatment of metastatic uveal ...
Novelwise Pharmaceutical Receives US FDA Fast Track ...
The designation was granted based on preclinical data in uveal melanoma models, as well as safety and dose information from previous Phase I ...
NBM-BMX - Drug Targets, Indications, Patents
... Safety, Efficacy and Pharmacokinetics of NBM-BMX in Patients With Metastatic Uveal ... HDAC8 inhibitor, for the treatment of metastatic uveal melanoma (mUM). The ...
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