NCT06012695 NBM-BMX Administered Orally to Patients With Solid Tumors or Newly Diagnosed Glioblastoma
| NCT ID | NCT06012695 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Novelwise Pharmaceutical Corporation |
| Condition | Malignant Neoplasm |
| Study Type | INTERVENTIONAL |
| Enrollment | 79 participants |
| Start Date | 2023-08-11 |
| Primary Completion | 2028-05-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 79 participants in total. It began in 2023-08-11 with a primary completion date of 2028-05-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: Arm A (advanced solid tumors) 1. Having signed and dated the informed consent form. 2. Females or males \> 18 years old. 3. Histologically or cytologically confirmed advanced solid tumors refractory to standard of care therapy, or for which no standard of care therapy is available. 4. 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). 5. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2. 6. Adequate organ function as defined by the following criteria: 1. Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) ≤ 3 × upper limits of normal (ULN), unless liver metastases present, then ≤ 5 × ULN 2. Total serum bilirubin ≤ 1.5 × ULN unless bilirubin elevation is related to Gilbert's Syndrome for which bilirubin ≤ 3 × ULN 3. Absolute neutrophil count (ANC) ≥ 1,000/μL 4. Platelets ≥ 75,000/μL 5. Hemoglobin ≥ 8.0 g/dL 6. Non-indexed estimated glomerular filtration rate (eGFR) ≥ 50 mL/min/1.73 m2 × BSA (m2)/1.73. Transfusion is not allowed to meet entry criteria. 7. QTcF ≤ 480 msec 8. Willingness and ability to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures. Arm B (newly diagnosed GBM) 1. Having signed and dated the informed consent form. 2. Females or males \> 18 years old. 3. Newly diagnosed, histologically confirmed glioblastoma, non-resectable, partially resected or resected. 4. Karnofsky performance status (KPS) ≥ 60 at screening and before the initiation (Day 1) of concomitant therapy. 5. Disease that is measurable or evaluable as defined by Response Assessment in Neuro-Oncology (RANO) criteria. 6. Adequate organ function as defined by the following criteria: 1. Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) ≤ 3 × upper limit of normal (ULN), unless liver metastases present, then ≤ 5 × ULN 2. Total serum bilirubin ≤ 1.5 × ULN unless bilirubin elevation is related to Gilbert's Syndrome for which bilirubin ≤ 3 × ULN 3. Absolute neutrophil count (ANC) ≥ 1,500/μL 4. Platelets ≥ 100,000/μL 5. Hemoglobin ≥ 8.0 g/dL 6. Non-indexed estimated glomerular filtration rate (eGFR) ≥ 60 mL/min/1.73 m2 × BSA (m2)/1.73. Transfusion is not allowed to meet entry criteria. 7. QTcF ≤ 480 msec 8. Willingness and ability to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures. Exclusion Criteria: Arm A (advanced solid tumors) 1. 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. 2. Curative radiation therapy within 28 days or palliative RT within 7 days of the first dose of NBM-BMX. 3. Currently taking strong inhibitors (e.g., gemfibrozil) or inducers of CYP2C8. 4. 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/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, or cerebrovascular accident including transient ischemic attack. 5. 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. 6. Known history of human immunodeficiency virus (HIV) infection. 7. Men and women of childbearing potential who are unwilling to use highly effective contraceptive methods during the study period. Highly effective contraceptive methods include implants, injectables, combined oral contraceptives, intra-uterine devices (IUDs), sexual abstinence, surgical sterilization or a partner who is sterile. 8. Females who are pregnant or breastfeeding. 9. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that would impart, in the judgement of the investigator and/or sponsor, excess risks associated with study participation or study drug administration. Arm B (newly diagnosed GBM) 1. Prior systemic therapy (including Gliadel wafer implant), immunotherapy, investigational agents, or radiotherapy for glioblastoma. 2. Currently taking strong inhibitors (e.g., gemfibrozil) or inducers of CYP2C8. 3. Corticosteroid use of \> 8 mg/day dexamethasone or equivalent within 5 days before the first dose of NBM-BMX. 4. A history of hypersensitivity reaction to temozolomide or dacarbazine. 5. 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/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, or cerebrovascular accident including transient ischemic attack. 6. 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. 7. Known history of human immunodeficiency virus (HIV) infection. Note: HIV testing is not required. 8. 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. Highly effective contraceptive methods include implants, injectables, combined oral contraceptives, intra-uterine devices (IUDs), sexual abstinence, surgical sterilization or a partner who is sterile. 9. Female who are pregnant or breastfeeding. 10. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that would impart, in the judgement of the investigator and/or sponsor, excess risks associated with study participation or study drug administration.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06012695 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Malignant Neoplasm. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06012695 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06012695 currently recruiting?
Yes, NCT06012695 is actively recruiting participants. Contact the research team at alison.hou@novelwisepharma.com for enrollment information.
Where is the NCT06012695 trial being conducted?
This trial is being conducted at Kaohsiung City, Taiwan, Taichung, Taiwan, Taipei, Taiwan, Taoyuan City, Taiwan.
Who is sponsoring the NCT06012695 clinical trial?
NCT06012695 is sponsored by Novelwise Pharmaceutical Corporation. The trial plans to enroll 79 participants.