Malignant NeoplasmPhase 1/2NCT06012695
NBM-BMX Administered Orally to Patients With Solid Tumors or Newly Diagnosed Glioblastoma
A Phase 1/2 study testing NBM-BMX Capsule, Temozolomide and Standard radiotherapy in people with Malignant Neoplasm and Malignant Neoplasm of Brain, run by Novelwise Pharmaceutical Corporation at 4 sites in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Neoplasm, Malignant Neoplasm of Brain
- What is being tested?
- NBM-BMX Capsule, Temozolomide and Standard radiotherapy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 4 sitesTaiwan
- Study dates
- 11 Aug 2023to 30 Sep 2029
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to 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.
Show all 32Show fewer
- 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.
Who cannot join
- 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.
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- 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.
- 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, 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. 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 contraceptive methods include implants, injectables, combined oral contraceptives, intra-uterine devices (IUDs), sexual abstinence, surgical sterilization or a partner who is sterile.
- 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 drug administration.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan4 sites, 4 recruiting
- Not yet recruiting
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 807
Ann-Shung Lieu, M.D., +886 7 3121101
- Recruiting
Taichung Veterans General Hospital
Taichung, 407
Wen-Yu Cheng, M.D., +886 4 23592525
- Recruiting
Koo Foundation Sun Yat-Sen Cancer Center
Taipei, 112
Chi-Feng Chung, M.D., +886 2 28970011
- Recruiting
Linkou Chang-Gung Memorial Hospital
Taoyuan City, 333
Kuo-Chen Wei, M.D., +886 3 3281200
About this study
Official title: 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
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.
Read the detailed description
This is a multi-center, open-label, 2-arm, phase Ib/II study to evaluate the safety, pharmacokinetics, and preliminary efficacy of NBM-BMX as monotherapy in the treatment of solid tumors (Arm A) or in combination with radiotherapy/temozolomide in the treatment of glioblastoma (Arm B).
Arm A consists of dose escalation cohorts in subjects with advanced solid tumors who will be treated with NBM-BMX monotherapy at different dose levels. Arm B consists of dose escalation cohorts (Phase Ib) and expansion cohorts (Phase II) in subjects with newly diagnosed glioblastoma (GBM). Subjects will be treated with NBM-BMX at different dose levels in combination with the first-line standard of care treatment (i.e., concomitant Radiotherapy (RT)/TMZ followed by adjuvant TMZ) in Phase Ib. After the recommended Phase 2 dose (RP2D) is determined in Phase Ib, additional subjects will be enrolled and treated at the RP2D to evaluate the efficacy of NBM-BMX combination therapy.
- Conditions
- Malignant Neoplasm, Malignant Neoplasm of Brain
- Being tested
- NBM-BMX Capsule, Temozolomide, Standard radiotherapy
- Medical subject headings
- Neoplasms, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NBM-BMX CapsuleDrug
Each capsule contains 100 mg of the active ingredient.
TemozolomideDrug
Also called Temodal® Capsules
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.
Standard radiotherapyRadiation
A total dose of 60 Gy will be administered in 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| monotherapy in advanced solid tumors | Experimental | Subjects with advanced solid tumors will be treated with NBM-BMX monotherapy at different dose levels depending on the order of their enrollment. Receives: Drug: NBM-BMX Capsule |
| combination therapy in newly diagnosed glioblastoma | Experimental | Subjects 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. Receives: Drug: NBM-BMX Capsule; Drug: Temozolomide; Radiation: Standard radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
[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.
Measured: 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.
Measured: 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.
Measured: up to 6 months
Secondary outcomes (6)
Frequency, types, severity, and relationship to NBM-BMX of adverse events (AEs)
The severity of AEs will be graded using NCI CTCAE Version 5.0 by the investigator.
Measured: up to 28 days
Preliminary assessment of anti-tumor activity by response evaluation criteria
Tumor response and progression will be assessed using the RECIST v1.1 or Response Assessment in Neuro-Oncology (RANO) criteria.
Measured: at least 8 weeks
Area under the plasma concentration versus time curve (AUC) of NBM-BMX
Blood samples will be collected at each pre-specified time point for measuring concentrations of NBM-BMX in plasma using a validated bioanalytical method.
Measured: Day 1, 8 and 15 for Cycle 1 only (each cycle is 28 days)
Peak plasma concentration (Cmax) of NBM-BMX
Blood samples will be collected at each pre-specified time point for measuring concentrations of NBM-BMX in plasma using a validated bioanalytical method.
Measured: Day 1, 8 and 15 for Cycle 1 only (each cycle is 28 days)
Time to maximum plasma concentration (Tmax) of NBM-BMX
Blood samples will be collected at each pre-specified time point for measuring concentrations of NBM-BMX in plasma using a validated bioanalytical method.
Measured: Day 1, 8 and 15 for Cycle 1 only (each cycle is 28 days)
Terminal elimination half-life (T1/2) of NBM-BMX
Blood samples will be collected at each pre-specified time point for measuring concentrations of NBM-BMX in plasma using a validated bioanalytical method.
Measured: Day 1, 8 and 15 for Cycle 1 only (each cycle is 28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2023
- Study start11 Aug 2023
- Primary completion30 May 2028 (estimated)
- Study completion30 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 79 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novelwise Pharmaceutical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06012695
- Sponsor's protocol ID
- NBM-BMX-003
- Status last verified
- Apr 2026
- First submitted
- 11 Aug 2023
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06012695
- Acronym / sponsor ID
- NBM-BMX-003
- Conditions
- Malignant Neoplasm, Malignant Neoplasm of Brain
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 79 participants (estimated)
- Lead sponsor
- Novelwise Pharmaceutical CorporationIndustry (pharma, biotech, devices)
- Study start
- 11 Aug 2023 (actual)
- Primary completion
- 30 May 2028 (estimated)
- Study completion
- 30 Sep 2029 (estimated)
- First posted
- 25 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a multi-center, open-label, 2-arm, phase Ib/II study to evaluate the safety, pharmacokinetics, and preliminary efficacy of NBM-BMX as monotherapy in the treatment of solid tumors (Arm A) or in combination with radiotherapy/temozolomide in the treatment of glioblastoma (Arm B).
Arm A consists of dose escalation cohorts in subjects with advanced solid tumors who will be treated with NBM-BMX monotherapy at different dose levels. Arm B consists of dose escalation cohorts (Phase Ib) and expansion cohorts (Phase II) in subjects with newly diagnosed glioblastoma (GBM). Subjects will be treated with NBM-BMX at different dose levels in combination with the first-line standard of care treatment (i.e., concomitant Radiotherapy (RT)/TMZ followed by adjuvant TMZ) in Phase Ib. After the recommended Phase 2 dose (RP2D) is determined in Phase Ib, additional subjects will be enrolled and treated at the RP2D to evaluate the efficacy of NBM-BMX combination therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| monotherapy in advanced solid tumors | Experimental | Drug: NBM-BMX CapsuleSubjects 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 | Experimental | Drug: NBM-BMX Capsule, Drug: Temozolomide, Radiation: Standard radiotherapySubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (32 listed)
- 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).
Key exclusion criteria (23 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NBM-BMX CapsuleEach capsule contains 100 mg of the active ingredient. | Drug | combination therapy in newly diagnosed glioblastoma, monotherapy in advanced solid tumors |
| TemozolomideAlso: Temodal® CapsulesTMZ 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. | Drug | combination therapy in newly diagnosed glioblastoma |
| Standard radiotherapyA total dose of 60 Gy will be administered in 6 weeks. | Radiation | combination therapy in newly diagnosed glioblastoma |
Primary outcome
[Arm A, Phase Ib] Frequency of dose-limiting toxicity (DLT) at each dose level
Time frame: up to 28 days
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.
[Arm B, Phase Ib] Frequency of dose-limiting toxicity (DLT) at each dose level
Time frame: up to 10 weeks
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.
[Arm B, Phase II] Progression-free survival rate at 6 months (PFS6)
Time frame: up to 6 months
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.
6 secondary outcomes
Frequency, types, severity, and relationship to NBM-BMX of adverse events (AEs)
Time frame: up to 28 days
Preliminary assessment of anti-tumor activity by response evaluation criteria
Time frame: at least 8 weeks
Area under the plasma concentration versus time curve (AUC) of NBM-BMX
Time frame: Day 1, 8 and 15 for Cycle 1 only (each cycle is 28 days)
Peak plasma concentration (Cmax) of NBM-BMX
Time frame: Day 1, 8 and 15 for Cycle 1 only (each cycle is 28 days)
Time to maximum plasma concentration (Tmax) of NBM-BMX
Time frame: Day 1, 8 and 15 for Cycle 1 only (each cycle is 28 days)
Terminal elimination half-life (T1/2) of NBM-BMX
Time frame: Day 1, 8 and 15 for Cycle 1 only (each cycle is 28 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing NBM-BMX Capsule, Temozolomide and Standard radiotherapy in people with Malignant Neoplasm and Malignant Neoplasm of Brain, run by Novelwise Pharmaceutical Corporation at 4 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 32 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chia-Chung Hou, Ph.D. (+886 2 26559109 ext. 101, alison.hou@novelwisepharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
[Arm A, Phase Ib] Frequency of dose-limiting toxicity (DLT) at each dose level (time frame: up to 28 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.