Evaluation of the Safety, Efficacy, and Pharmacokinetics of NBM-BMX in Patients With Metastatic U… (NCT07136181) | Clinical Trial Compass
RecruitingPhase 1/2
Evaluation of the Safety, Efficacy, and Pharmacokinetics of NBM-BMX in Patients With Metastatic Uveal Melanoma
United States36 participantsStarted 2025-11-20
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Signed, written IRB-approved informed consent.
✓. Men and women age ≥ 18 years
✓. ECOG Performance status ≤ 2
✓. Have measurable disease based on RECIST 1.1
✓. Histologic or cytologic confirmation of metastatic uveal melanoma
✓. Previous Therapy
✓. QTcF \<= 480 msec
✓. Adequate hematopoietic capacity, as defined by the following:
Exclusion criteria
✕. Pregnant or nursing women. NOTE: Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; or abstinence) prior to study entry and for the duration of study participation and for at least 6 months after the last dose of NBM-BMX. Should a man father a child, or a woman become pregnant or suspect she is pregnant while participating in this study, he or she should inform the treating physician immediately.
What they're measuring
1
Phase Ib: Incidence of dose-limiting toxicities (DLTs)
Timeframe: Time Frame: Cycle 1 (up to 28 days)
2
Phase Ib: Maximum Tolerated Dose (MTD)
Timeframe: Cycle 1 (up to 28 days)
3
Phase II: Objective Response Rate (ORR)
Timeframe: Assessed every 8-12 weeks from first dose; up to ~24 months
✕. Concurrent non-protocol-specified anti-tumor therapy (e.g., chemotherapy, other targeted therapy, radiation therapy, or photodynamic therapy)
✕. History of other malignancies within 3 years of Day 1, except for tumors with a negligible risk for metastasis or death, such as adequately treated squamous-cell carcinoma of the skin, ductal carcinoma in situ of the breast, or carcinoma in situ of the cervix.
✕. Active or uncontrolled infections or with serious illnesses or medical conditions which would not permit the patient to be managed according to the protocol.
✕. History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug or that might affect interpretation of the results of the study or renders the patient at high risk from treatment complications.
✕. Difficulty with swallowing oral medications.
✕. Currently taking moderate and strong inhibitors (e.g., gemfibrozil) or inducers of CYP2C8.
✕. A positive test for hepatitis B (HBsAg) and/or hepatitis C (anti-HCV antibody), unless the HBV DNA level and/or HCV RNA level is below the limit of detection.