NBM-BMX for Eye Cancer

(NBM-BMX-UM Trial)

Recruiting at 2 trial locations

Overseen By John Soong, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Novelwise Pharmaceutical Corporation

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

36 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

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

I have signed the consent form approved by the ethics board.

It has been two weeks since my last treatment.

My cancer can be measured by scans.

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?

Group I: In the present Phase Ib/II study, up to three dose levels are planned Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Novelwise Pharmaceutical Corporation

Lead Sponsor

Trials

1

Recruited

80+