Study of NBM-BMX Capsules to Treat Adults With Metastatic Uveal Melanoma Evaluating Safety, Effectiveness, and How the Body Processes the Drug

What this Trial Is About

Researchers are evaluating the investigational drug NBM-BMX for adults with metastatic uveal melanoma, an eye cancer that has spread to other parts of the body. This study aims to find the best dose of NBM-BMX, understand its side effects, how the body processes it, and whether it may slow or shrink tumors. The trial is in Phase IbII and involves patients who have measurable metastatic disease confirmed by biopsy and meet specific health criteria. Participants will take NBM-BMX capsules orally twice daily on an empty stomach with water, avoiding food and drink except water for at least one hour before and two hours after each dose. The study plans up to four dose levels ranging from 200 mg to 800 mg daily. Treatment continues in 28-day cycles until disease progression, unacceptable side effects, or voluntary withdrawal. Patients will visit the clinic about weekly or biweekly for exams, blood tests, and drug dispensing, and they will keep dosing diaries to track medication use and symptoms. Throughout the study, participants undergo safety monitoring including physical exams, vital signs, ECGs, and lab tests. Tumor response is assessed every 8 weeks using RECIST 1.1 criteria. After stopping treatment, a follow-up visit occurs about 30 days later. The total participation duration varies depending on individual response and tolerability. The study also evaluates pharmacokinetics and records any dose-limiting toxicities or objective tumor responses.

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