Clinical Trials List
Protocol NumberNBM-BMX-003
NCT Number(ClinicalTrials.gov Identfier)NCT06012695
2023-08-01 - 2027-04-30
Phase I/II
Not yet recruiting2
Recruiting3
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
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Sponsor
Novelwise Pharmaceutical Corporation
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Trial scale
Taiwan Multiple Center
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Update
2025/11/08
Investigators and Locations
Co-Principal Investigator
- Chi-Ting Liau Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- ZHENG-WEI ZHOU Division of Hematology & Oncology
- 傅景佟 Division of Others
- YU-HSUAN SHIH Division of Hematology & Oncology
- 陳文賢 Division of Radiology
- HSIN-CHEN LIN Division of Hematology & Oncology
- 李權 Division of Radiation Therapy
- CHENG-HSIEN LIN Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Principal Investigator
劉安祥
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Condition/Disease
Newly Diagnosed Glioblastoma
Objectives
Group A (Monotherapy – Advanced Solid Tumors)
Primary Objective:
• To determine the maximum tolerated dose (MTD) of NBM-BMX monotherapy in patients with advanced solid tumors.
Secondary Objectives:
• To evaluate the safety and tolerability of NBM-BMX monotherapy.
• To characterize the pharmacokinetics (PK) of NBM-BMX capsules.
• To assess the preliminary efficacy of NBM-BMX monotherapy.
Group B (Combination Therapy – Newly Diagnosed Glioblastoma)
Primary Objectives:
Phase 1b (Dose Escalation)
• To determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D) of NBM-BMX in combination with radiotherapy and temozolomide (TMZ) in patients with newly diagnosed glioblastoma.
Phase 2 (Expansion Cohort)
• To evaluate the efficacy of NBM-BMX in combination with radiotherapy and TMZ in patients with newly diagnosed glioblastoma.
Secondary Objectives (Phase 1b and Phase 2):
• To evaluate the safety and tolerability of NBM-BMX in combination with radiotherapy and TMZ.
• To characterize the pharmacokinetics (PK) of NBM-BMX capsules when administered with radiotherapy and TMZ.
Exploratory Objective (Phase 1b and Phase 2):
• To evaluate the relationship between tumor response and various molecular biomarkers.
Test Drug
NBM-BMX
Active Ingredient
NBM-BMX
Dosage Form
Hard Gel Capsule
Dosage
100mg
Endpoints
Group A (Advanced Solid Tumors)
• Incidence of dose-limiting toxicities (DLTs) in each dose cohort.
Group B (Newly Diagnosed Glioblastoma)
Phase 1b
• Incidence of dose-limiting toxicities (DLTs) in each dose cohort.
Phase 2
• Progression-free survival rate at 6 months (PFS6 rate).
• Incidence of dose-limiting toxicities (DLTs) in each dose cohort.
Group B (Newly Diagnosed Glioblastoma)
Phase 1b
• Incidence of dose-limiting toxicities (DLTs) in each dose cohort.
Phase 2
• Progression-free survival rate at 6 months (PFS6 rate).
Inclution Criteria
Inclusion Criteria:
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.
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.
Exclusion Criteria
Exclusion Criteria:
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.
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.
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.
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.
The Estimated Number of Participants
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Taiwan
79 participants
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Global
79 participants
