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RecruitingPhase 1Phase 2NCT07136181

Evaluation of the Safety, Efficacy, and Pharmacokinetics of NBM-BMX in Patients With Metastatic Uveal Melanoma

A Multicenter Phase Ib/II Study to Evaluate the Safety, Efficacy and Pharmacokinetics of NBM-BMX in Patients With Metastatic Uveal Melanoma

Sponsor

Novelwise Pharmaceutical Corporation

Enrollment

36 participants

Start Date

Nov 20, 2025

Study Type

INTERVENTIONAL

Conditions

Metastatic Uveal MelanomaUveal Melanoma, MetastaticUveal Melanoma, RecurrentEye Cancer, Intraocular MelanomaEye Cancer

Summary

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 that has spread to other parts of the body. The study will help doctors learn about the side effects of NBM-BMX, how the drug is processed in the body, and whether it may slow down or shrink tumors. Participants will take NBM-BMX as a capsule by mouth twice daily on an empty stomach with at least six ounces (180 mL) of water. No food or drink (other than water) should be consumed for at least two hours after each dose. Participants will visit the clinic about once every week or two for exams and blood tests while taking NBM-BMX. After stopping treatment, a follow-up visit will occur about 30 days later. Treatment may continue as long as the cancer does not get worse and side effects remain manageable.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new experimental drug in people with metastatic uveal melanoma — a rare and aggressive cancer that begins in the eye. There is currently no approved standard treatment for this cancer once it has spread, so this trial aims to find safe and effective options. **You may be eligible if...** - You are 18 or older - You have confirmed metastatic uveal melanoma (melanoma that started in the eye and has spread) - Your cancer is measurable on scans - You are in reasonably good health (ECOG 0-2) - You have had prior treatments, including chemotherapy if applicable - At least 4 weeks have passed since your last major surgery and your wound has healed **You may NOT be eligible if...** - You have active, uncontrolled infection or other serious conditions - You have brain metastases that are active or untreated - You are pregnant or breastfeeding - You have had certain prior therapies that would interfere with this drug Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNBM-BMX Capsule are proprietary products developed by Novelwise Pharmaceutical Corporation (Novelwise) for treatment of patients suffering from cancers.

NBM-BMX is a small molecule inhibitor of HDAC8. The majority of metastasizing uveal melanoma (UM) cases are characterized by the presence of BAP1 mutations. However, as BAP1 mutations lead to a loss of function, therapeutic strategies have primarily focused on exploiting vulnerabilities resulting from BAP1 loss or targeting downstream effectors affected by the BAP1-deficient phenotype. In uveal melanocytes, the absence of BAP1 disrupts their differentiated cell identity, potentially contributing to the metastatic behavior observed in BAP1-mutant UM cells. This differentiation block in the melanocytic lineage is thought to be influenced, at least in part, by the activation of HDAC8 downstream, which leads to the repression of differentiation genes through acetylation of the histone H3K27 at the promoter and enhancers associated with these genes. Consequently, inhibiting HDAC8 could potentially reverse the differentiation block caused by the loss of BAP1.

Locations(3)

Honor Health Resarch Institute

Scottsdale, Arizona, United States

Sarah Cannon Research Institute (SCRI) - Denver HealthONE Location

Denver, Colorado, United States

SCRI Oncology Partners

Nashville, Tennessee, United States

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NCT07136181

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