New capsule aims to fight rare eye cancer that spreads
NCT ID NCT07136181
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests an experimental drug called NBM-BMX in people with metastatic uveal melanoma, a rare eye cancer that has spread to other parts of the body. The goal is to find the best dose, check for side effects, and see if the drug can shrink or slow tumors. Participants take the capsule twice daily and visit the clinic regularly for checkups.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- NBM-BMX (a capsule that blocks a protein called HDAC8, which may help slow cancer growth)
- What this could lead to
- If it works, this could point toward a new treatment option for people with metastatic uveal melanoma, a rare and hard-to-treat eye cancer.
- What could go wrong
- This is an early-phase trial with only 36 participants, so results may not apply to everyone. The drug may cause side effects or fail to shrink tumors.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 36 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2025
- Expected to finish
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Aug 2029
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: \- Patients must meet the following criteria to be eligible for study entry: 1. Signed, written IRB-approved informed consent. 2. Men and women age ≥ 18 years 3. ECOG Performance status ≤ 2 4. Have measurable disease based on RECIST 1.1 5. Histologic or cytologic confirmation of metastatic uveal melanoma 6. Previous Therapy * 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. Patients must have recovered (to baseline or ≤ grade 1) from all reversible toxicity related to prior chemotherapy or systemic therapy and have adequate washout as follows: Longest of one of the following: * Two weeks, * 5 half-lives for investigational agents, o For anti-cancer therapies with half-lives \> 8 days, a washout period of at least 28 days will be acceptable, * 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: \- Renal: calculated creatinine clearance \>45 mL/min for patients between 18 and 70 years old with abnormal, increased, creatinine levels (Cockcroft-Gault formula; Appendix F). For patients who are greater than 70 years old, investigator judgment may be used to assess the renal risk of study participation. 11. Women/men of childbearing potential must have agreed to use two effective contraceptive methods while on study and for 6 months after the last dose of NBM-BMX. 12. Willingness and ability to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures. Exclusion Criteria: Patients who meet the following criteria will be excluded from study entry: 1. 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. 2. Concurrent non-protocol-specified anti-tumor therapy (e.g., chemotherapy, other targeted therapy, radiation therapy, or photodynamic therapy) 3. 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. 4. Active or uncontrolled infections or with serious illnesses or medical conditions which would not permit the patient to be managed according to the protocol. 5. 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. 6. Difficulty with swallowing oral medications. 7. Currently taking moderate and strong inhibitors (e.g., gemfibrozil) or inducers of CYP2C8. 8. 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. 9. Any of the following within 3 months of the first dose of NBM-BMX: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, or cerebrovascular accident including transient ischemic attack. 10. Current use or anticipated need for P-gp or BCRP inhibitors during the study period. 11. Use of proton pump inhibitors (PPIs), H2-receptor antagonists, or other systemic acid-reducing agents within 7 days prior to Cycle 1 Day 1 or planned use during the study treatment period, unless the patient can be switched to local antacids (e.g., calcium carbonate or aluminum hydroxide) taken at least 2 hours before or after NBM-BMX dosing. Patients unable or unwilling to comply with this restriction should be excluded. Exceptions must be discussed with and approved by the Medical Monitor.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Honor Health Resarch Institute
RECRUITINGScottsdale, Arizona, 85258, United States
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SCRI Oncology Partners
RECRUITINGNashville, Tennessee, 37203, United States
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Sarah Cannon Research Institute (SCRI) - Denver HealthONE Location
RECRUITINGDenver, Colorado, 80218, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Double immunotherapy plus liver blockade targets eye cancer that spreads
- First-in-Class cancer drug targets Hard-to-Treat tumors
- Engineered immune cells take on Hard-to-Treat melanoma