NBM-BMX Administered Orally to Patients With Solid Tumors or Newly Diagnosed Glioblastoma
A Phase Ib/II, Open-label Study of NBM-BMX as Monotherapy or in Combination With Radiotherapy and Temozolomide in Subjects With Solid Tumors or Newly Diagnosed Glioblastoma
1 other identifier
interventional
79
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Aug 2023
Longer than P75 for phase_1
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 11, 2023
CompletedStudy Start
First participant enrolled
August 11, 2023
CompletedFirst Posted
Study publicly available on registry
August 25, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 30, 2029
April 29, 2026
April 1, 2026
4.8 years
August 11, 2023
April 24, 2026
Conditions
Outcome Measures
Primary Outcomes (3)
[Arm A, Phase Ib] Frequency of dose-limiting toxicity (DLT) at each dose level
To determine the maximum tolerated dose (MTD) for NBM-BMX monotherapy in subjects with advanced solid tumors, toxicities will be graded according to the National Cancer Institute Common Terminology.
up to 28 days
[Arm B, Phase Ib] Frequency of dose-limiting toxicity (DLT) at each dose level
To determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) for NBM-BMX in combination with RT and TMZ in subjects with newly diagnosed GBM, toxicities will be graded according to the National Cancer Institute Common Terminology.
up to 10 weeks
[Arm B, Phase II] Progression-free survival rate at 6 months (PFS6)
To assess the preliminary efficacy of NBM-BMX in combination with RT and TMZ in subjects with newly diagnosed GBM, the investigators will evaluate anti-tumor activity using RANO criteria.
up to 6 months
Secondary Outcomes (6)
Frequency, types, severity, and relationship to NBM-BMX of adverse events (AEs)
up to 28 days
Preliminary assessment of anti-tumor activity by response evaluation criteria
at least 8 weeks
Area under the plasma concentration versus time curve (AUC) of NBM-BMX
Day 1, 8 and 15 for Cycle 1 only (each cycle is 28 days)
Peak plasma concentration (Cmax) of NBM-BMX
Day 1, 8 and 15 for Cycle 1 only (each cycle is 28 days)
Time to maximum plasma concentration (Tmax) of NBM-BMX
Day 1, 8 and 15 for Cycle 1 only (each cycle is 28 days)
- +1 more secondary outcomes
Study Arms (2)
monotherapy in advanced solid tumors
EXPERIMENTALSubjects with advanced solid tumors will be treated with NBM-BMX monotherapy at different dose levels depending on the order of their enrollment.
combination therapy in newly diagnosed glioblastoma
EXPERIMENTALSubjects with newly diagnosed glioblastoma will be treated with NBM-BMX at different dose levels in combination with the standard of care treatment (concomitant RT/TMZ followed by adjuvant TMZ). In the expansion study, Subjects will be treated with NBM-BMX at the recommended Phase 2 dose (RP2D) in combination with RT/TMZ.
Interventions
Each capsule contains 100 mg of the active ingredient.
TMZ will be administered orally at a 75 mg/m2 dose daily during concomitant therapy. In the maintenance period, days 1-5 of each cycle will be administered 150-200 mg/m2.
A total dose of 60 Gy will be administered in 6 weeks.
Eligibility Criteria
You may qualify 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 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
- +17 more criteria
You may not qualify 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 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, congestive heart failure, or cerebrovascular accident including transient ischemic attack.
- 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 contraceptives, intra-uterine devices (IUDs), sexual abstinence, surgical sterilization or a partner who is sterile.
- 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 drug administration.
- Arm B (newly diagnosed GBM)
- 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.
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 807, Taiwan
Taichung Veterans General Hospital
Taichung, 407, Taiwan
Koo Foundation Sun Yat-Sen Cancer Center
Taipei, 112, Taiwan
Linkou Chang-Gung Memorial Hospital
Taoyuan, 333, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 11, 2023
First Posted
August 25, 2023
Study Start
August 11, 2023
Primary Completion (Estimated)
May 30, 2028
Study Completion (Estimated)
September 30, 2029
Last Updated
April 29, 2026
Record last verified: 2026-04