OncoMatch/Clinical Trials/NCT07136181
Evaluation of the Safety, Efficacy, and Pharmacokinetics of NBM-BMX in Patients With Metastatic Uveal Melanoma
Is NCT07136181 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies NBM-BMX Capsule are proprietary products developed by Novelwise Pharmaceutical Corporation (Novelwise) for treatment of patients suffering from cancers. for metastatic uveal melanoma.
Treatment: NBM-BMX Capsule are proprietary products developed by Novelwise Pharmaceutical Corporation (Novelwise) for treatment of patients suffering from cancers. — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Melanoma
Biomarker criteria
Required: HLA-A HLA-A*02:01-positive
Prior treatment with tebentafusp is required for HLA-A*02:01-positive patients unless unavailable or clinically inappropriate
Disease stage
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
ECOG Performance status ≤ 2
Prior therapy
Must have received: tebentafusp (tebentafusp) — metastatic
Prior treatment with tebentafusp is required for HLA-A*02:01-positive patients unless unavailable or clinically inappropriate
Cannot have received: HDAC inhibitor
Prior HDAC inhibitor treatment is not permitted
Lab requirements
Blood counts
Hemoglobin ≥ 9.0 g/dL and not transfusion dependent; Platelets ≥ 100,000/mm3; Absolute neutrophil count ≥ 1,500 cells/mm3
Kidney function
calculated creatinine clearance >45 mL/min for patients between 18 and 70 years old with abnormal, increased, creatinine levels (Cockcroft-Gault formula). For patients >70 years old, investigator judgment may be used.
Liver function
AST and ALT ≤ 2.5 times 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
Cardiac function
QTcF <= 480 msec; Exclusion of myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, or cerebrovascular accident within 3 months of first dose
QTcF <= 480 msec; Adequate hematopoietic capacity, as defined by: Hemoglobin ≥ 9.0 g/dL and not transfusion dependent; Platelets ≥ 100,000/mm3; Absolute neutrophil count ≥ 1,500 cells/mm3; Adequate hepatic function, as defined by: AST and ALT ≤ 2.5 times 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; Adequate renal function, as defined by: calculated creatinine clearance >45 mL/min for patients between 18 and 70 years old with abnormal, increased, creatinine levels (Cockcroft-Gault formula). For patients >70 years old, investigator judgment may be used.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Honor Health Resarch Institute · Scottsdale, Arizona
- Sarah Cannon Research Institute (SCRI) - Denver HealthONE Location · Denver, Colorado
- SCRI Oncology Partners · Nashville, Tennessee
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