Ten-year follow-up of helium ion therapy for uveal melanoma.
D H Char, S M Kroll, J Castro
https://pubmed.ncbi.nlm.nih.gov/9437317Actively Recruiting
Phase 1
Phase 2
Age: 18Years +
All Genders
ID07136181
A Multicenter Phase Ib/II Study to Evaluate 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
74 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the investigational drug NBM-BMX for adults with metastatic uveal melanoma, an eye cancer that has spread to other parts of the body. This study aims to find the best dose of NBM-BMX, understand its side effects, how the body processes it, and whether it may slow or shrink tumors. The trial is in Phase Ib/II and involves patients who have measurable metastatic disease confirmed by biopsy and meet specific health criteria. Participants will take NBM-BMX capsules orally twice daily on an empty stomach with water, avoiding food and drink (except water) for at least one hour before and two hours after each dose. The study plans up to four dose levels ranging from 200 mg to 800 mg daily. Treatment continues in 28-day cycles until disease progression, unacceptable side effects, or voluntary withdrawal. Patients will visit the clinic about weekly or biweekly for exams, blood tests, and drug dispensing, and they will keep dosing diaries to track medication use and symptoms. Throughout the study, participants undergo safety monitoring including physical exams, vital signs, ECGs, and lab tests. Tumor response is assessed every 8 weeks using RECIST 1.1 criteria. After stopping treatment, a follow-up visit occurs about 30 days later. The total participation duration varies depending on individual response and tolerability. The study also evaluates pharmacokinetics and records any dose-limiting toxicities or objective tumor responses.
CONDITIONS
Brief Title
Evaluation of the Safety, Efficacy, and Pharmacokinetics of NBM-BMX in Patients With Metastatic Uveal Melanoma
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Signed, written IRB-approved informed consent.
- Adults aged 18 years or older.
- ECOG Performance status of 0, 1, or 2.
- Measurable metastatic uveal melanoma based on RECIST 1.1.
- Histologic or cytologic confirmation of metastatic uveal melanoma.
- Previous therapies allowed with adequate recovery and washout periods, including surgery (minimum 28 days since major surgery).
- Prior treatment with tebentafusp required for HLA-A*02:01-positive patients unless unavailable or inappropriate.
- Adequate heart function with QTcF less than or equal to 480 msec.
- Adequate blood counts: hemoglobin at least 9.0 g/dL, platelets at least 100,000/mm3, neutrophils at least 1,500 cells/mm3.
- Adequate liver function: AST and ALT less than or equal to 2.5 times upper limit of normal or up to 5 times if liver metastases present; total bilirubin less than or equal to 1.5 times upper limit of normal or within 3 times if Gilbert disease; albumin at least 3.0 g/dL.
- Adequate kidney function with creatinine clearance over 45 mL/min for patients 18 to 70 years old; investigator judgment for older patients.
- Agreement to use two effective forms of contraception if of childbearing potential during and for 6 months after treatment.
- Ability and willingness to comply with study visits, treatments, and tests.
You will not qualify if you...
- Pregnant or nursing women.
- Concurrent anti-tumor therapies not specified in the protocol.
- History of other cancers within 3 years except low-risk tumors like treated skin squamous cell carcinoma or in situ breast or cervical carcinoma.
- Active or uncontrolled infections or serious medical conditions preventing protocol management.
- Any disease or condition that contraindicates use of investigational drugs or affects study results.
- Difficulty swallowing oral medications.
- Taking moderate or strong CYP2C8 inhibitors or inducers.
- Positive hepatitis B or C tests unless viral levels are undetectable.
- Recent heart conditions within 3 months such as heart attack, unstable angina, bypass surgery, heart failure, or stroke.
- Current or planned use of P-gp or BCRP inhibitors during the study.
- Use of proton pump inhibitors, H2 blockers, or systemic acid reducers within 7 days before starting treatment or planned during treatment unless switched to local antacids.
- Inability or unwillingness to comply with acid-reducing agent restrictions unless approved by the Medical Monitor.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Treatment
Duration - Repeated 28-day cycles until disease progression or discontinuation
Participants take the study drug NBM-BMX orally twice daily for 28 consecutive days per cycle, continuing treatment until disease progression, intolerable side effects, or voluntary withdrawal.
Visits every 8 weeks for tumor assessment and regular visits for drug dispensing and monitoring
Follow-up
Duration - Up to 30 days after last dose
Participants who discontinue treatment return to the clinic for a follow-up visit within 30 days after the last dose to monitor safety and collect final data.
1 follow-up visit (in-person)
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
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Research Team
A
Annie Pai, PhD
J
John Soong, MD
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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