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New treatment option for Malignant Neoplasm
Official title NBM-BMX Administered Orally to Patients With Solid Tumors or Newly Diagnosed Glioblastoma
ClinicalTrials.gov ID: NCT06012695
What this study is testing
What is NBM-BMX Capsule?
NBM-BMX Capsule is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for malignant neoplasm.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Arm A (advanced solid tumors)
- Having signed and dated the informed consent form.
- Females or males \> 18 years old.
- Histologically or cytologically confirmed advanced solid tumors refractory to standard of care therapy, or for which no standard of care therapy is...
- Disease that is measurable or evaluable as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or Response Assessment in...
You likely can't join if
- Arm A (advanced solid tumors)
- 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...
- Curative radiation therapy within 28 days or palliative RT within 7 days of the first dose of NBM-BMX.
- Currently taking strong inhibitors (e.g., gemfibrozil) or inducers of CYP2C8.
- Any of the following within 6 months of the first dose of NBM-BMX: pulmonary embolism events, deep vein thrombosis (DVT) events, myocardial...
- 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...
See the full eligibility criteria
Who can join
- Arm A (advanced solid tumors)
- Having signed and dated the informed consent form.
- Females or males \> 18 years old.
- Histologically or cytologically confirmed advanced solid tumors refractory to standard of care therapy, or for which no standard of care therapy is available.
- 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).
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.
- Adequate organ function as defined by the following criteria:
- Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) ≤ 3 × upper limits of normal (ULN), unless liver metastases present, then ≤ 5 × ULN
- Total serum bilirubin ≤ 1.5 × ULN unless bilirubin elevation is related to Gilbert's Syndrome for which bilirubin ≤ 3 × ULN
- Absolute neutrophil count (ANC) ≥ 1,000/μL
- Platelets ≥ 75,000/μL
- Hemoglobin ≥ 8.0 g/dL
- 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.
- QTcF ≤ 480 msec
- Willingness and ability to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures. Arm B (newly diagnosed GBM)
- Having signed and dated the informed consent form.
- Females or males \> 18 years old.
- Newly diagnosed, histologically confirmed glioblastoma, non-resectable, partially resected or resected.
- Karnofsky performance status (KPS) ≥ 60 at screening and before the initiation (Day 1) of concomitant therapy.
- Disease that is measurable or evaluable as defined by Response Assessment in Neuro-Oncology (RANO) criteria.
- Adequate organ function as defined by the following criteria:
- Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) ≤ 3 × upper limit of normal (ULN), unless liver metastases present, then ≤ 5 × ULN
- Total serum bilirubin ≤ 1.5 × ULN unless bilirubin elevation is related to Gilbert's Syndrome for which bilirubin ≤ 3 × ULN
- Absolute neutrophil count (ANC) ≥ 1,500/μL
- Platelets ≥ 100,000/μL
- Hemoglobin ≥ 8.0 g/dL
- 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.
- QTcF ≤ 480 msec
- Willingness and ability to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures.
What rules you out
- Arm A (advanced solid tumors)
- 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.
- Curative radiation therapy within 28 days or palliative RT within 7 days of the first dose of NBM-BMX.
- Currently taking strong inhibitors (e.g., gemfibrozil) or inducers of CYP2C8.
- 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...
- 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.
- Known history of human immunodeficiency virus (HIV) infection.
- 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...
- Females who are pregnant or breastfeeding.
- 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...
- Prior systemic therapy (including Gliadel wafer implant), immunotherapy, investigational agents, or radiotherapy for glioblastoma.
- Currently taking strong inhibitors (e.g., gemfibrozil) or inducers of CYP2C8.
- Corticosteroid use of \> 8 mg/day dexamethasone or equivalent within 5 days before the first dose of NBM-BMX.
- A history of hypersensitivity reaction to temozolomide or dacarbazine.
- 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...
- 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.
- Known history of human immunodeficiency virus (HIV) infection. Note: HIV testing is not required.
- 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...
- Female who are pregnant or breastfeeding.
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Kaohsiung City, Taiwan
- Taichung, Taiwan
- Taipei, Taiwan
- Taoyuan City, Taiwan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Kaohsiung City, Taiwan; Taichung, Taiwan; Taipei, Taiwan; Taoyuan City, Taiwan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.