[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Novelwise Pharmaceutical Corporation\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":96},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,40,62],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":5},"100636696","phase-1-a-rollover-study-of-nbm-bmx-in-combination-with-temozolomide-in-patients-with-newly-diagnosed-glioblastoma-100636696",false,"NCT07569042","A Rollover Study of NBM-BMX in Combination With Temozolomide in Patients With Newly Diagnosed Glioblastoma","A Rollover Study to Evaluate the Long-Term Safety and Efficacy of NBM-BMX in Combination With Temozolomide in Patients With Newly Diagnosed Glioblastoma Who Completed Study NBM-BMX-003 (the Parent Study)","Inclusion Criteria:\n\nParticipants must meet all of the following criteria to be eligible for the study:\n\n1. Have completed or currently enrolled in Arm B of Study NBM-BMX-003 (the parent study), and in the opinion of the Investigator, may derive clinical benefit from continued treatment with study drugs.\n2. Histologically confirmed glioblastoma.\n3. Can enroll into this rollover study within 35 days after completing the last dose of NBM-BMX in the parent study.\n4. Have signed and dated the informed consent form.\n5. Karnofsky performance status (KPS) ≥ 60 at enrollment in this study.\n6. Adequate organ functions as defined by the following criteria:\n\n   1. Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) ≤ 3 × upper limit of normal (ULN)\n   2. Total serum bilirubin ≤ 1.5 × ULN unless bilirubin elevation is related to Gilbert's Syndrome for which bilirubin ≤ 3 × ULN\n   3. Absolute neutrophil count (ANC) ≥ 1,000\u002FµL\n   4. Platelets ≥ 75,000\u002FµL\n   5. Hemoglobin ≥ 8.0 g\u002FdL\n   6. Non-indexed estimated glomerular filtration rate (eGFR) ≥ 50 mL\u002Fmin\n7. Women of childbearing potential must have a negative pregnancy test performed within 14 days before the first dose of this study.\n8. Men and women of childbearing potential must agree to use acceptable contraceptive methods throughout the study period and for at least 6 months after the final dose of temozolomide.\n\n   Acceptable contraceptive methods include implants, injectables, combined oral contraceptives, intra-uterine devices (IUDs), sexual abstinence, surgical sterilization or a partner who is sterile.\n9. Willingness and ability to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures.\n\nExclusion Criteria:\n\nParticipants with any of the following will be excluded from the study:\n\n1. Currently receive or plan to receive anti-cancer treatments other than the study drugs including Gliadel wafer implant or tumor treating fields (TTFields).\n2. Permanently discontinued from the parent study due to unacceptable toxicity, non-compliance with study procedures, withdrawal of consent, or any other reason.\n3. 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.\n4. QTcF \\> 480 msec\n5. Currently taking strong inhibitors (e.g., gemfibrozil) or inducers of CYP2C8.\n6. Have known hypersensitivity reaction to temozolomide, dacarbazine or NBM-BMX.\n7. Have difficulty swallowing (including those require nasogastric tube) or with impaired absorption of oral medications.\n8. Female who are pregnant or breastfeeding.\n9. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that would impart, in the judgement of the Investigator and\u002For sponsor, excess risks associated with study participation or study drug administration.","ALL","18 Years",{"count":19,"type":20},15,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","This clinical trial is a rollover study designed to provide continued access to NBM-BMX and temozolomide (TMZ) for eligible participants with newly diagnosed glioblastoma who have completed the designated treatment in Study NBM-BMX-003 (the parent study), and to evaluate the long-term safety and efficacy of NBM-BMX administered in combination with TMZ.",[27],"Malignant Neoplasm of Brain","RECRUITING","2026-05-01",{"date":31,"type":32},"2026-05-06","ACTUAL",{"date":34,"type":32},"2026-04-20",{"date":36,"type":20},"2030-12-31",{"name":38,"class":39},"Novelwise Pharmaceutical Corporation","INDUSTRY",{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":47,"targetDuration":4,"studyType":21,"phases":49,"briefSummary":50,"conditions":51,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":53,"lastUpdatePostDateStruct":54,"startDateStruct":56,"completionDateStruct":58,"leadSponsor":60,"locationsCount":61},"100517065","phase-1-nbm-bmx-administered-orally-to-patients-with-solid-tumors-or-newly-diagnosed-glioblastoma-100517065","NCT06012695","NBM-BMX Administered Orally to Patients With Solid Tumors or Newly Diagnosed Glioblastoma","A Phase Ib\u002FII, Open-label Study of NBM-BMX as Monotherapy or in Combination With Radiotherapy and Temozolomide in Subjects With Solid Tumors or Newly Diagnosed Glioblastoma","Inclusion Criteria:\n\nArm A (advanced solid tumors)\n\n1. Having signed and dated the informed consent form.\n2. Females or males \\> 18 years old.\n3. Histologically or cytologically confirmed advanced solid tumors refractory to standard of care therapy, or for which no standard of care therapy is available.\n4. Disease that is measurable or evaluable as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or Response Assessment in Neuro-Oncology (RANO) criteria (for CNS tumors).\n5. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.\n6. Adequate organ function as defined by the following criteria:\n\n   1. Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) ≤ 3 × upper limits of normal (ULN), unless liver metastases present, then ≤ 5 × ULN\n   2. Total serum bilirubin ≤ 1.5 × ULN unless bilirubin elevation is related to Gilbert's Syndrome for which bilirubin ≤ 3 × ULN\n   3. Absolute neutrophil count (ANC) ≥ 1,000\u002FμL\n   4. Platelets ≥ 75,000\u002FμL\n   5. Hemoglobin ≥ 8.0 g\u002FdL\n   6. Non-indexed estimated glomerular filtration rate (eGFR) ≥ 50 mL\u002Fmin\u002F1.73 m2 × BSA (m2)\u002F1.73.\n\n   Transfusion is not allowed to meet entry criteria.\n7. QTcF ≤ 480 msec\n8. Willingness and ability to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures.\n\nArm B (newly diagnosed GBM)\n\n1. Having signed and dated the informed consent form.\n2. Females or males \\> 18 years old.\n3. Newly diagnosed, histologically confirmed glioblastoma, non-resectable, partially resected or resected.\n4. Karnofsky performance status (KPS) ≥ 60 at screening and before the initiation (Day 1) of concomitant therapy.\n5. Disease that is measurable or evaluable as defined by Response Assessment in Neuro-Oncology (RANO) criteria.\n6. Adequate organ function as defined by the following criteria:\n\n   1. Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) ≤ 3 × upper limit of normal (ULN), unless liver metastases present, then ≤ 5 × ULN\n   2. Total serum bilirubin ≤ 1.5 × ULN unless bilirubin elevation is related to Gilbert's Syndrome for which bilirubin ≤ 3 × ULN\n   3. Absolute neutrophil count (ANC) ≥ 1,500\u002FμL\n   4. Platelets ≥ 100,000\u002FμL\n   5. Hemoglobin ≥ 8.0 g\u002FdL\n   6. Non-indexed estimated glomerular filtration rate (eGFR) ≥ 60 mL\u002Fmin\u002F1.73 m2 × BSA (m2)\u002F1.73.\n\n   Transfusion is not allowed to meet entry criteria.\n7. QTcF ≤ 480 msec\n8. Willingness and ability to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures.\n\nExclusion Criteria:\n\nArm A (advanced solid tumors)\n\n1. Systemic anti-cancer treatment (investigational or approved) within 28 days or 5 half-lives of that drug (whichever is shorter) of the first dose of NBM-BMX.\n2. Curative radiation therapy within 28 days or palliative RT within 7 days of the first dose of NBM-BMX.\n3. Currently taking strong inhibitors (e.g., gemfibrozil) or inducers of CYP2C8.\n4. Any of the following within 6 months of the first dose of NBM-BMX: pulmonary embolism events, deep vein thrombosis (DVT) events, myocardial infarction, severe\u002Funstable angina, coronary\u002Fperipheral artery bypass graft, congestive heart failure, or cerebrovascular accident including transient ischemic attack.\n5. 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.\n6. Known history of human immunodeficiency virus (HIV) infection.\n7. Men and women of childbearing potential who are unwilling to use highly effective contraceptive methods during the study period.\n\n   Highly effective contraceptive methods include implants, injectables, combined oral contraceptives, intra-uterine devices (IUDs), sexual abstinence, surgical sterilization or a partner who is sterile.\n8. Females who are pregnant or breastfeeding.\n9. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that would impart, in the judgement of the investigator and\u002For sponsor, excess risks associated with study participation or study drug administration.\n\nArm B (newly diagnosed GBM)\n\n1. Prior systemic therapy (including Gliadel wafer implant), immunotherapy, investigational agents, or radiotherapy for glioblastoma.\n2. Currently taking strong inhibitors (e.g., gemfibrozil) or inducers of CYP2C8.\n3. Corticosteroid use of \\> 8 mg\u002Fday dexamethasone or equivalent within 5 days before the first dose of NBM-BMX.\n4. A history of hypersensitivity reaction to temozolomide or dacarbazine.\n5. Any of the following within 6 months of the first dose of NBM-BMX: pulmonary embolism events, deep vein thrombosis (DVT) events, myocardial infarction, severe\u002Funstable angina, coronary\u002Fperipheral artery bypass graft, congestive heart failure, or cerebrovascular accident including transient ischemic attack.\n6. 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.\n7. Known history of human immunodeficiency virus (HIV) infection. Note: HIV testing is not required.\n8. Men and women of childbearing potential who are unwilling to use highly effective contraceptive methods during the study period and for at least 6 months after the final dose of temozolomide.\n\n   Highly effective contraceptive methods include implants, injectables, combined oral contraceptives, intra-uterine devices (IUDs), sexual abstinence, surgical sterilization or a partner who is sterile.\n9. Female who are pregnant or breastfeeding.\n10. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that would impart, in the judgement of the investigator and\u002For sponsor, excess risks associated with study participation or study drug administration.",{"count":48,"type":20},79,[23,24],"NBM-BMX is an orally available new chemical entity to inhibit histone deacetylases 8 (HDAC8) activity specifically, being developed as a potential anti-cancer therapeutic by NatureWise. This study aims to evaluate the safety, pharmacokinetics, and preliminary efficacy of NBM-BMX as monotherapy in subjects with advanced solid tumors or combination with the standard of care treatment in subjects with newly diagnosed glioblastoma.",[52,27],"Malignant Neoplasm","2026-04-24",{"date":55,"type":32},"2026-04-29",{"date":57,"type":32},"2023-08-11",{"date":59,"type":20},"2029-09-30",{"name":38,"class":39},4,{"id":63,"slug":64,"hasResults":11,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":68,"eligibilityCriteria":69,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":70,"targetDuration":4,"studyType":21,"phases":72,"briefSummary":73,"conditions":74,"keywords":80,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":5},"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":71,"type":20},36,[23,24],"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.",[75,76,77,78,79],"Metastatic Uveal Melanoma","Uveal Melanoma, Metastatic","Uveal Melanoma, Recurrent","Eye Cancer, Intraocular Melanoma","Eye Cancer",[75,81,79,82,83,84,85,86,87],"Uveal Melanoma","Intraocular Melanoma","Choroidal Melanoma","NBM-BMX","Histone Deacetylase Inhibitor (HDAC inhibitor)","Phase 1b\u002F2 Study","Pharmacokinetics","2025-11-21",{"date":90,"type":32},"2025-11-28",{"date":92,"type":32},"2025-11-20",{"date":94,"type":20},"2029-08-30",{"name":38,"class":39},""]