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NBM-BMX for Metastatic Uveal Melanoma

This study is testing an investigational drug called NBM-BMX for people with metastatic uveal melanoma (a type of eye cancer that has spread). NBM-BMX is a capsule taken by mouth. The study aims to find the best dose of NBM-BMX, understand its side effects, and see how it works in the body. Researchers also want to know if NBM-BMX can shrink or slow the growth of tumors. You may be able to join if you are 18 or older, have metastatic uveal melanoma confirmed by a doctor, and meet other health criteria. The study will measure how many people have their tumors shrink or stop growing. The current status of this study is unclear, and it plans to enroll 36 participants.

Study design
This is an interventional study with a planned enrollment of 36 participants. It aims to determine the best dose and effectiveness of NBM-BMX.
What's involved
You would take NBM-BMX capsules twice daily on an empty stomach. You would visit the clinic about once every week or two for exams and blood tests while on treatment.
Compensation
Not stated in the trial record.
Follow-up
After stopping treatment, a follow-up visit will occur about 30 days later. Tumor assessments will continue every 8-12 weeks for up to about 24 months.

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NCT07136181

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Novelwise Pharmaceutical Corporation
~36 participants
Updated 2025-11-28 on ClinicalTrials.gov
What's tested:NBM-BMX Capsule are proprietary products developed by Novelwise Pharmaceutical Corporation (Novelwise) for treatment of patients suffering from cancers.

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Phase Ib: Incidence of dose-limiting toxicities (DLTs)
Measured over Time Frame: Cycle 1 (up to 28 days)
+2 more outcomes measured

Conditions

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

Explore related trials

Uveal Melanoma

Where it's being run

3 sites across 3 states
Arizona1
Colorado1
Tennessee1

Who to contact

Annie Pai, PhD
[email protected]
1 (910) 297-9045
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Surgery: Previous surgery is permitted provided that a minimum of 28 days (4 weeks) has elapsed between any major surgery and date of registration, and that wound healing has occurred.
Cytotoxic Chemotherapy: There is no limit to the number of prior regimens received.
Other Systemic Therapy: There is no limit to the number of prior therapies received for metastatic uveal melanoma. Prior treatment with tebentafusp is required for HLA-A\*02:01-positive patients unless unavailable or clinically inappropriate, as determined by the investigator. Prior HDAC inhibitor treatment is not permitted.
Two weeks,
5 half-lives for investigational agents,
Standard cycle length of standard therapies. 7. QTcF \<= 480 msec 8. Adequate hematopoietic capacity, as defined by the following:
Hemoglobin ≥ 9.0 g/dL and not transfusion dependent
Platelets ≥ 100,000/mm3
Absolute neutrophil count ≥ 1,500 cells/mm3 9. Adequate hepatic function, as defined by the following:
AST and ALT ≤ 2.5 times upper limit of normal (ULN) or ≤ 5 times ULN if liver metastases are present
Total bilirubin ≤ 1.5 x ULN or within 3x the ULN for patients with Gilbert disease
Albumin ≥ 3.0 g/dL 10. Adequate renal function, as defined by the following:

What this trial measures

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

    Participants experiencing a DLT during Cycle 1 (28 days)

  • Phase Ib: Maximum Tolerated Dose (MTD)Cycle 1 (up to 28 days)

    The highest dose level with ≤1 of 6 participants with a DLT, based on the incidence of DLTs at each dose level of NBM-BMX during Cycle 1 (28 days). MTD will inform the recommended Phase 2 dose (RP2D) of NBM-BMX

  • Phase II: Objective Response Rate (ORR)Assessed every 8-12 weeks from first dose; up to ~24 months

    Proportion of patients with complete response (CR) + partial response (PR) determined per RECIST 1.1 while on NBM-BMX.