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

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.

Timeline

Start

2025-11-20

Primary completion

2028-03-28

Completion

2029-08-30

Publications

• Results Char DH, Kroll SM, Castro J. Ten-year follow-up of helium ion therapy for uveal melanoma. Am J Ophthalmol. 1998 Jan;125(1):81-9. doi: 10.1016/s0002-9394(99)80238-4.
• Results Yang W, Feng Y, Zhou J, Cheung OK, Cao J, Wang J, Tang W, Tu Y, Xu L, Wu F, Tan Z, Sun H, Tian Y, Wong J, Lai PB, Chan SL, Chan AW, Tan PB, Chen Z, Sung JJ, Yip KY, To KF, Cheng AS. A selective HDAC8 inhibitor potentiates antitumor immunity and efficacy of immune checkpoint blockade in hepatocellular carcinoma. Sci Transl Med. 2021 Apr 7;13(588):eaaz6804. doi: 10.1126/scitranslmed.aaz6804.
• Results Diener-West M, Reynolds SM, Agugliaro DJ, Caldwell R, Cumming K, Earle JD, Hawkins BS, Hayman JA, Jaiyesimi I, Jampol LM, Kirkwood JM, Koh WJ, Robertson DM, Shaw JM, Straatsma BR, Thoma J; Collaborative Ocular Melanoma Study Group. Development of metastatic disease after enrollment in the COMS trials for treatment of choroidal melanoma: Collaborative Ocular Melanoma Study Group Report No. 26. Arch Ophthalmol. 2005 Dec;123(12):1639-43. doi: 10.1001/archopht.123.12.1639.

Drugs

Indications