Actively Recruiting
Evaluation of the Safety, Efficacy, and Pharmacokinetics of NBM-BMX in Patients With Metastatic Uveal Melanoma
Led by Novelwise Pharmaceutical Corporation · Updated on 2025-11-28
36
Participants Needed
3
Research Sites
197 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Evaluation of the Safety, Efficacy, and Pharmacokinetics of NBM-BMX in Patients With Metastatic Uveal Melanoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed, written informed consent approved by an IRB
- Men and women aged 18 years or older
- ECOG performance status of 0, 1, or 2
- Measurable disease based on RECIST 1.1 criteria
- Histologic or cytologic confirmation of metastatic uveal melanoma
- Previous surgery allowed if at least 28 days have passed and healing is complete
- No limit on prior chemotherapy or systemic therapies, but no prior HDAC inhibitor treatment
- HLA-A*02:01-positive patients must have prior tebentafusp treatment unless unavailable or inappropriate
- Recovery from all reversible side effects of prior treatments and adequate washout periods observed
- QTcF of 480 msec or less
- Adequate blood counts: hemoglobin 9.0 g/dL or higher and not transfusion dependent, platelets 100,000/mm3 or higher, absolute neutrophil count 1,500 cells/mm3 or higher
- Adequate liver function: AST and ALT no more than 2.5 times upper normal limit (or 5 times with liver metastases), bilirubin not exceeding 1.5 times upper limit (or within 3 times for Gilbert disease), albumin 3.0 g/dL or higher
- Adequate kidney function: creatinine clearance above 45 mL/min for ages 18 to 70, with investigator judgment for older patients
- Agreement to use two effective contraceptive methods during and for 6 months after treatment
- Willingness and ability to comply with study visits, treatments, and tests
You will not qualify if you...
- Pregnant or nursing women
- Use of other anti-tumor treatments not specified in the study during participation
- History of other cancers within 3 years except for low-risk skin or breast or cervical cancers
- Active or uncontrolled infections or serious medical conditions preventing protocol management
- Any disease or condition that increases risk from the investigational drug or affects study results
- Difficulty swallowing oral medications
- Current use of moderate or strong CYP2C8 inhibitors or inducers
- Positive hepatitis B or C test unless viral levels are undetectable
- Heart conditions within 3 months before starting treatment, including heart attack, unstable angina, bypass surgery, heart failure, or stroke
- Current or expected use of P-gp or BCRP inhibitors
- Use of proton pump inhibitors, H2 receptor antagonists, or systemic acid-reducing agents within 7 days before starting treatment or planned use during the study, unless switched to approved local antacids
- Inability or unwillingness to comply with medication restrictions on acid-reducing agents
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Honor Health Resarch Institute
Scottsdale, Arizona, United States, 85258
Actively Recruiting
2
Sarah Cannon Research Institute (SCRI) - Denver HealthONE Location
Denver, Colorado, United States, 80218
Actively Recruiting
3
SCRI Oncology Partners
Nashville, Tennessee, United States, 37203
Actively Recruiting
Research Team
A
Annie Pai, PhD
CONTACT
J
John Soong, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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