Status:
RECRUITING
NBM-BMX Administered Orally to Patients with Solid Tumors or Newly Diagnosed Glioblastoma
Lead Sponsor:
Novelwise Pharmaceutical Corporation
Conditions:
Malignant Neoplasm
Malignant Neoplasm of Brain
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 aim...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 11 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2029
Estimated Enrollment :
79 Patients enrolled
Trial Details
Trial ID
NCT06012695
Start Date
August 11 2023
End Date
September 30 2029
Last Update
November 14 2024
Active Locations (5)
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1
Hualien Tzu Chi Hospital
Hualien City, Taiwan, 970
2
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan, 807
3
Taichung Veterans General Hospital
Taichung, Taiwan, 407
4
Koo Foundation Sun Yat-Sen Cancer Center
Taipei, Taiwan, 112