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

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Novelwise Pharmaceutical Corporation
Study ID
NCT07136181
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Eye Cancer
  • Eye Cancer, Intraocular Melanoma
  • Metastatic Uveal Melanoma
  • Uveal Melanoma, Metastatic
  • Uveal Melanoma, Recurrent

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Nov 20, 2025
Status verified
Nov 2025
Primary completion
Mar 28, 2028
Completion
Aug 30, 2029

Study Design

Enrollment
36 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: In the present Phase Ib/II study, up to three dose levels are planned
    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.

Primary Outcome Measure

Phase Ib: Incidence of dose-limiting toxicities (DLTs) [ Time Frame: Time Frame: Cycle 1 (up to 28 days) ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Honor Health Resarch InstituteScottsdaleArizona85258-
Sarah Cannon Research Institute (SCRI) - Denver HealthONE LocationDenverColorado80218-
SCRI Oncology PartnersNashvilleTennessee37203-

Find similar trials in Scottsdale, AZ

By research site
Honor Health Resarch Institute· Scottsdale, AZSarah Cannon Research Institute (SCRI) - Denver HealthONE Location· Denver, COSCRI Oncology Partners· Nashville, TN

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