[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"uveal-melanoma-recurrent\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:uveal-melanoma-recurrent":33},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,83],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":41,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":82},"100517783","phase-1-a-dose-escalation-and-dose-expansion-study-of-intratumoral-onm-501-alone-and-in-combination-with-cemiplimab-in-patients-with-advanced-solid-tumors-and-lymphomas-100517783",false,"NCT06022029","A Dose Escalation and Dose Expansion Study of Intratumoral ONM-501 Alone and in Combination With Cemiplimab in Patients With Advanced Solid Tumors and Lymphomas.","A Phase 1 Dose-Escalation and Expansion Study of Intratumorally Administered ONM-501 Alone and in Combination With Cemiplimab in Patients With Advanced Solid Tumors and Lymphomas","ON-5001","Inclusion Criteria:\n\n1. Ability to understand and willingness to sign written informed consent before performance of any study procedures\n2. Age ≥ 18 years\n3. Participants with solid tumors or lymphomas, confirmed by available histopathology records or current biopsy, that are advanced, nonresectable, or recurrent and progressing since last antitumor therapy, and for which no alternative standard therapy exists.\n4. Participants must have a minimum of one injectable and measurable lesion.\n5. Participants with prior Hepatitis B or C are eligible if they have adequate liver function\n6. Participants with human immunodeficiency virus (HIV) are eligible if on established HAART for a minimum of 4 weeks prior to enrollment, have an HIV viral load \\\u003C400 copies\u002FmL, and have CD4+ T-cell (CD4+) counts ≥ 350 cells\u002FuL\n7. Adequate bone marrow function:\n8. Adequate liver function\n\nExclusion Criteria: Patients will be excluded from this study if they meet any of the following criteria (Part 1a and Part 1b).\n\n1. Other malignancy active within the previous 2 years except for basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast that has completed curative therapy.\n2. Major surgery within 4 weeks before the first dose of study drug.\n3. Brain metastases that are untreated or in the posterior fossa or involve the meninges. Participants with stable or previously treated progressing brain metastases (except in the posterior fossa or involving the meninges) may be permitted in a case-by-case basis at the Sponsor's discretion.\n4. Prolongation of corrected QT (QTc) interval to \\>470 millisecond (ms) for males and females when electrolytes balance is normal.\n5. Females who are breastfeeding or pregnant at screening or baseline\n6. Females of childbearing potential that refuse to use a highly effective method of contraception.\n7. Has uncontrolled or poorly controlled hypertension as defined by a sustained BP \\> 9. Has received prior investigational therapy within 5 half-lives of the agent or 4 weeks before the first administration of study drug, whichever is shorter.\n8. Has had any major cardiovascular event within 6 months prior to study drug 10. Has known hypersensitivity to any component in the formulation of ONM-501\n9. Has an active infection requiring systemic treatment\n10. Is participating in another therapeutic clinical trial\n\nAdditional Exclusion Criteria for ONM-501 in Combination with cemiplimab (Part 1b)\n\n1. Has known hypersensitivity to any component in the formulation of cemiplimab\n2. Has any active or recent history of a known or suspected autoimmune disease or recent history of a syndrome that required systemic corticosteroids (\\>10 mg daily prednisone equivalent)\n3. Has a condition requiring systemic treatment with corticosteroids","ALL","18 Years",{"count":20,"type":21},168,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","A phase 1, multicenter, open label, non-randomized dose escalation and dose expansion study to examine the maximum tolerated dose, (MTD), minimum effective dose (MED) and\u002For recommended dose for expansion (RDE) of intratumoral ONM-501 as monotherapy and in combination with a PD-1 checkpoint inhibitor in patients with advanced solid tumors and lymphomas.",[27,28,29,30,31,32,33,34,35,36,37,38,39,40],"Triple Negative Breast Cancer","Diffuse Large B Cell Lymphoma","Follicular Lymphoma","Lymphoma, Non-Hodgkin","Mantle Cell Lymphoma","Bladder Cancer","Uveal Melanoma, Recurrent","Cervix Cancer","Carcinoma in Situ","Head and Neck Squamous Cell Carcinoma","Skin Cancer","Metastatic Cancer","Tumor, Solid","Tumor Recurrence",[42,43,44,45,46,47,48,49,37,50,51,52,53,54,55,56,57,58,59,60,61,62,63,64,65,66,67,68,69],"Solid tumors","Lymphoma","ONM-501","STING","Intra-tumoral","HNSCC","Breast Cancer","Melanoma","cemiplimab","Libtayo","DLBCL","bladder cancer","cervical cancer","metastases","immunotherapy","ICI","TNBC","Triple Negative","mTNBC","anti-PD-1 antibody","BRCA1","BRCA2","anti-PD-L1","uveal","NHL","Mantle Zone lymphoma","FL","stimulator of interferon genes","RECRUITING","2025-12-18",{"date":73,"type":74},"2025-12-24","ACTUAL",{"date":76,"type":74},"2023-10-13",{"date":78,"type":21},"2026-08-29",{"name":80,"class":81},"OncoNano Medicine, Inc.","INDUSTRY",16,{"id":84,"slug":85,"hasResults":11,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":89,"eligibilityCriteria":90,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":91,"targetDuration":4,"studyType":22,"phases":93,"briefSummary":95,"conditions":96,"keywords":101,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":118},"100603412","phase-1-evaluation-of-the-safety-efficacy-and-pharmacokinetics-of-nbm-bmx-in-patients-with-metastatic-uveal-melanoma-100603412","NCT07136181","Evaluation of the Safety, Efficacy, and Pharmacokinetics of NBM-BMX in Patients With Metastatic Uveal Melanoma","A Multicenter Phase Ib\u002FII Study to Evaluate the Safety, Efficacy and Pharmacokinetics of NBM-BMX in Patients With Metastatic Uveal Melanoma","NBM-BMX-UM","Inclusion Criteria:\n\n\\- Patients must meet the following criteria to be eligible for study entry:\n\n1. Signed, written IRB-approved informed consent.\n2. Men and women age ≥ 18 years\n3. ECOG Performance status ≤ 2\n4. Have measurable disease based on RECIST 1.1\n5. Histologic or cytologic confirmation of metastatic uveal melanoma\n6. Previous Therapy\n\n   * 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.\n   * Cytotoxic Chemotherapy: There is no limit to the number of prior regimens received.\n   * 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.\n\n   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:\n\n   Longest of one of the following:\n   * Two weeks,\n   * 5 half-lives for investigational agents,\n\n     o For anti-cancer therapies with half-lives \\> 8 days, a washout period of at least 28 days will be acceptable,\n   * Standard cycle length of standard therapies.\n7. QTcF \\\u003C= 480 msec\n8. Adequate hematopoietic capacity, as defined by the following:\n\n   * Hemoglobin ≥ 9.0 g\u002FdL and not transfusion dependent\n   * Platelets ≥ 100,000\u002Fmm3\n   * Absolute neutrophil count ≥ 1,500 cells\u002Fmm3\n9. Adequate hepatic function, as defined by the following:\n\n   * AST and ALT ≤ 2.5 times upper limit of normal (ULN) or ≤ 5 times ULN if liver metastases are present\n   * Total bilirubin ≤ 1.5 x ULN or within 3x the ULN for patients with Gilbert disease\n   * Albumin ≥ 3.0 g\u002FdL\n10. Adequate renal function, as defined by the following:\n\n    \\- Renal: calculated creatinine clearance \\>45 mL\u002Fmin 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.\n11. Women\u002Fmen 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.\n12. Willingness and ability to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures.\n\nExclusion Criteria:\n\nPatients who meet the following criteria will be excluded from study entry:\n\n1. 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.\n2. Concurrent non-protocol-specified anti-tumor therapy (e.g., chemotherapy, other targeted therapy, radiation therapy, or photodynamic therapy)\n3. 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.\n4. Active or uncontrolled infections or with serious illnesses or medical conditions which would not permit the patient to be managed according to the protocol.\n5. 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.\n6. Difficulty with swallowing oral medications.\n7. Currently taking moderate and strong inhibitors (e.g., gemfibrozil) or inducers of CYP2C8.\n8. A positive test for hepatitis B (HBsAg) and\u002For hepatitis C (anti-HCV antibody), unless the HBV DNA level and\u002For HCV RNA level is below the limit of detection.\n9. Any of the following within 3 months of the first dose of NBM-BMX: myocardial infarction, severe\u002Funstable angina, coronary\u002Fperipheral artery bypass graft, congestive heart failure, or cerebrovascular accident including transient ischemic attack.\n10. Current use or anticipated need for P-gp or BCRP inhibitors during the study period.\n11. 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.\n\nPatients unable or unwilling to comply with this restriction should be excluded. Exceptions must be discussed with and approved by the Medical Monitor.",{"count":92,"type":21},36,[24,94],"PHASE2","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.\n\nThe 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.\n\nParticipants 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.\n\nParticipants 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.\n\nTreatment may continue as long as the cancer does not get worse and side effects remain manageable.",[97,98,33,99,100],"Metastatic Uveal Melanoma","Uveal Melanoma, Metastatic","Eye Cancer, Intraocular Melanoma","Eye Cancer",[97,102,100,103,104,105,106,107,108],"Uveal Melanoma","Intraocular Melanoma","Choroidal Melanoma","NBM-BMX","Histone Deacetylase Inhibitor (HDAC inhibitor)","Phase 1b\u002F2 Study","Pharmacokinetics","2025-11-21",{"date":111,"type":74},"2025-11-28",{"date":113,"type":74},"2025-11-20",{"date":115,"type":21},"2029-08-30",{"name":117,"class":81},"Novelwise Pharmaceutical Corporation",3]