xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06012695</url>
    </required_header>
    <id_info>
      <org_study_id>NBM-BMX-003</org_study_id>
      <nct_id>NCT06012695</nct_id>
    </id_info>
    <brief_title>NBM-BMX Administered Orally to Patients With Solid Tumors or Newly Diagnosed Glioblastoma</brief_title>
    <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</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>NatureWise Biotech &amp; Medicals Corporation</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>NatureWise Biotech &amp; Medicals Corporation</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        NBM-BMX is an orally available new chemical entity to inhibit histone deacetylases 8 (HDAC8)&#xD;
        activity specifically, being developed as a potential anti-cancer therapeutic by NatureWise.&#xD;
        This study aims to evaluate the safety, pharmacokinetics, and preliminary efficacy of NBM-BMX&#xD;
        as monotherapy in subjects with advanced solid tumors or combination with the standard of&#xD;
        care treatment in subjects with newly diagnosed glioblastoma.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a multi-center, open-label, 2-arm, phase Ib/II study to evaluate the safety,&#xD;
        pharmacokinetics, and preliminary efficacy of NBM-BMX as monotherapy in the treatment of&#xD;
        solid tumors (Arm A) or in combination with radiotherapy/temozolomide in the treatment of&#xD;
        glioblastoma (Arm B).&#xD;
  &#xD;
        Arm A consists of dose escalation cohorts in subjects with advanced solid tumors who will be&#xD;
        treated with NBM-BMX monotherapy at different dose levels. Arm B consists of dose escalation&#xD;
        cohorts (Phase Ib) and expansion cohorts (Phase II) in subjects with newly diagnosed&#xD;
        glioblastoma (GBM). Subjects will be treated with NBM-BMX at different dose levels in&#xD;
        combination with the first-line standard of care treatment (i.e., concomitant Radiotherapy&#xD;
        (RT)/TMZ followed by adjuvant TMZ) in Phase Ib. After the recommended Phase 2 dose (RP2D) is&#xD;
        determined in Phase Ib, additional subjects will be enrolled and treated at the RP2D to&#xD;
        evaluate the efficacy of NBM-BMX combination therapy.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 11, 2023</start_date>
    <completion_date type="Anticipated">September 30, 2029</completion_date>
    <primary_completion_date type="Anticipated">May 30, 2028</primary_completion_date>
    <phase>Phase 1/Phase 2</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>[Arm A, Phase Ib] Frequency of dose-limiting toxicity (DLT) at each dose level</measure>
      <time_frame>up to 28 days</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>[Arm B, Phase Ib] Frequency of dose-limiting toxicity (DLT) at each dose level</measure>
      <time_frame>up to 10 weeks</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>[Arm B, Phase II] Progression-free survival rate at 6 months (PFS6)</measure>
      <time_frame>up to 6 months</time_frame>
      <description>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.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Frequency, types, severity, and relationship to NBM-BMX of adverse events (AEs)</measure>
      <time_frame>up to 28 days</time_frame>
      <description>The severity of AEs will be graded using NCI CTCAE Version 5.0 by the investigator.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Preliminary assessment of anti-tumor activity by response evaluation criteria</measure>
      <time_frame>at least 8 weeks</time_frame>
      <description>Tumor response and progression will be assessed using the RECIST v1.1 or Response Assessment in Neuro-Oncology (RANO) criteria.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Area under the plasma concentration versus time curve (AUC) of NBM-BMX</measure>
      <time_frame>Day 1, 8 and 15 for Cycle 1 only (each cycle is 28 days)</time_frame>
      <description>Blood samples will be collected at each pre-specified time point for measuring concentrations of NBM-BMX in plasma using a validated bioanalytical method.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Peak plasma concentration (Cmax) of NBM-BMX</measure>
      <time_frame>Day 1, 8 and 15 for Cycle 1 only (each cycle is 28 days)</time_frame>
      <description>Blood samples will be collected at each pre-specified time point for measuring concentrations of NBM-BMX in plasma using a validated bioanalytical method.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to maximum plasma concentration (Tmax) of NBM-BMX</measure>
      <time_frame>Day 1, 8 and 15 for Cycle 1 only (each cycle is 28 days)</time_frame>
      <description>Blood samples will be collected at each pre-specified time point for measuring concentrations of NBM-BMX in plasma using a validated bioanalytical method.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Terminal elimination half-life (T1/2) of NBM-BMX</measure>
      <time_frame>Day 1, 8 and 15 for Cycle 1 only (each cycle is 28 days)</time_frame>
      <description>Blood samples will be collected at each pre-specified time point for measuring concentrations of NBM-BMX in plasma using a validated bioanalytical method.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">79</enrollment>
    <condition>Malignant Neoplasm</condition>
    <condition>Malignant Neoplasm of Brain</condition>
    <arm_group>
      <arm_group_label>monotherapy in advanced solid tumors</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Subjects with advanced solid tumors will be treated with NBM-BMX monotherapy at different dose levels depending on the order of their enrollment.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>combination therapy in newly diagnosed glioblastoma</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>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.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>NBM-BMX Capsule</intervention_name>
      <description>Each capsule contains 100 mg of the active ingredient.</description>
      <arm_group_label>combination therapy in newly diagnosed glioblastoma</arm_group_label>
      <arm_group_label>monotherapy in advanced solid tumors</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Temozolomide</intervention_name>
      <description>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.</description>
      <arm_group_label>combination therapy in newly diagnosed glioblastoma</arm_group_label>
      <other_name>Temodal® Capsules</other_name>
    </intervention>
    <intervention>
      <intervention_type>Radiation</intervention_type>
      <intervention_name>Standard radiotherapy</intervention_name>
      <description>A total dose of 60 Gy will be administered in 6 weeks.</description>
      <arm_group_label>combination therapy in newly diagnosed glioblastoma</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Arm A (advanced solid tumors)&#xD;
  &#xD;
            1. Having signed and dated the informed consent form.&#xD;
  &#xD;
            2. Females or males &gt; 18 years old.&#xD;
  &#xD;
            3. Histologically or cytologically confirmed advanced solid tumors refractory to standard&#xD;
               of care therapy, or for which no standard of care therapy is available.&#xD;
  &#xD;
            4. Disease that is measurable or evaluable as defined by Response Evaluation Criteria in&#xD;
               Solid Tumors (RECIST) v1.1 or Response Assessment in Neuro-Oncology (RANO) criteria&#xD;
               (for CNS tumors).&#xD;
  &#xD;
            5. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.&#xD;
  &#xD;
            6. Adequate organ function as defined by the following criteria:&#xD;
  &#xD;
                 1. Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) ≤ 3 ×&#xD;
                    upper limits of normal (ULN), unless liver metastases present, then ≤ 5 × ULN&#xD;
  &#xD;
                 2. Total serum bilirubin ≤ 1.5 × ULN unless bilirubin elevation is related to&#xD;
                    Gilbert's Syndrome for which bilirubin ≤ 3 × ULN&#xD;
  &#xD;
                 3. Absolute neutrophil count (ANC) ≥ 1,000/μL&#xD;
  &#xD;
                 4. Platelets ≥ 75,000/μL&#xD;
  &#xD;
                 5. Hemoglobin ≥ 8.0 g/dL&#xD;
  &#xD;
                 6. Non-indexed estimated glomerular filtration rate (eGFR) ≥ 50 mL/min/1.73 m2 × BSA&#xD;
                    (m2)/1.73.&#xD;
  &#xD;
               Transfusion is not allowed to meet entry criteria.&#xD;
  &#xD;
            7. QTcF ≤ 480 msec&#xD;
  &#xD;
            8. Willingness and ability to comply with the study scheduled visits, treatment plans,&#xD;
               laboratory tests and other procedures.&#xD;
  &#xD;
          Arm B (newly diagnosed GBM)&#xD;
  &#xD;
            1. Having signed and dated the informed consent form.&#xD;
  &#xD;
            2. Females or males &gt; 18 years old.&#xD;
  &#xD;
            3. Newly diagnosed, histologically confirmed glioblastoma, non-resectable, partially&#xD;
               resected or resected.&#xD;
  &#xD;
            4. Karnofsky performance status (KPS) ≥ 60 at screening and before the initiation (Day 1)&#xD;
               of concomitant therapy.&#xD;
  &#xD;
            5. Disease that is measurable or evaluable as defined by Response Assessment in&#xD;
               Neuro-Oncology (RANO) criteria.&#xD;
  &#xD;
            6. Adequate organ function as defined by the following criteria:&#xD;
  &#xD;
                 1. Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) ≤ 3 ×&#xD;
                    upper limit of normal (ULN), unless liver metastases present, then ≤ 5 × ULN&#xD;
  &#xD;
                 2. Total serum bilirubin ≤ 1.5 × ULN unless bilirubin elevation is related to&#xD;
                    Gilbert's Syndrome for which bilirubin ≤ 3 × ULN&#xD;
  &#xD;
                 3. Absolute neutrophil count (ANC) ≥ 1,500/μL&#xD;
  &#xD;
                 4. Platelets ≥ 100,000/μL&#xD;
  &#xD;
                 5. Hemoglobin ≥ 8.0 g/dL&#xD;
  &#xD;
                 6. Non-indexed estimated glomerular filtration rate (eGFR) ≥ 60 mL/min/1.73 m2 × BSA&#xD;
                    (m2)/1.73.&#xD;
  &#xD;
               Transfusion is not allowed to meet entry criteria.&#xD;
  &#xD;
            7. QTcF ≤ 480 msec&#xD;
  &#xD;
            8. Willingness and ability to comply with the study scheduled visits, treatment plans,&#xD;
               laboratory tests and other procedures.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Arm A (advanced solid tumors)&#xD;
  &#xD;
            1. Systemic anti-cancer treatment (investigational or approved) within 28 days or 5&#xD;
               half-lives of that drug (whichever is shorter) of the first dose of NBM-BMX.&#xD;
  &#xD;
            2. Curative radiation therapy within 28 days or palliative RT within 7 days of the first&#xD;
               dose of NBM-BMX.&#xD;
  &#xD;
            3. Currently taking strong inhibitors (e.g., gemfibrozil) or inducers of CYP2C8.&#xD;
  &#xD;
            4. Any of the following within 6 months of the first dose of NBM-BMX: pulmonary embolism&#xD;
               events, deep vein thrombosis (DVT) events, myocardial infarction, severe/unstable&#xD;
               angina, coronary/peripheral artery bypass graft, congestive heart failure, or&#xD;
               cerebrovascular accident including transient ischemic attack.&#xD;
  &#xD;
            5. A positive test for hepatitis B (HBsAg) and/or hepatitis C (anti-HCV antibody), unless&#xD;
               the HBV DNA level and/or HCV RNA level is below the limit of detection.&#xD;
  &#xD;
            6. Known history of human immunodeficiency virus (HIV) infection.&#xD;
  &#xD;
            7. Men and women of childbearing potential who are unwilling to use highly effective&#xD;
               contraceptive methods during the study period.&#xD;
  &#xD;
               Highly effective contraceptive methods include implants, injectables, combined oral&#xD;
               contraceptives, intra-uterine devices (IUDs), sexual abstinence, surgical&#xD;
               sterilization or a partner who is sterile.&#xD;
  &#xD;
            8. Females who are pregnant or breastfeeding.&#xD;
  &#xD;
            9. Other severe acute or chronic medical or psychiatric condition or laboratory&#xD;
               abnormality that would impart, in the judgement of the investigator and/or sponsor,&#xD;
               excess risks associated with study participation or study drug administration.&#xD;
  &#xD;
          Arm B (newly diagnosed GBM)&#xD;
  &#xD;
            1. Prior systemic therapy (including Gliadel wafer implant), immunotherapy,&#xD;
               investigational agents, or radiotherapy for glioblastoma.&#xD;
  &#xD;
            2. Currently taking strong inhibitors (e.g., gemfibrozil) or inducers of CYP2C8.&#xD;
  &#xD;
            3. Corticosteroid use of &gt; 8 mg/day dexamethasone or equivalent within 5 days before the&#xD;
               first dose of NBM-BMX.&#xD;
  &#xD;
            4. A history of hypersensitivity reaction to temozolomide or dacarbazine.&#xD;
  &#xD;
            5. Any of the following within 6 months of the first dose of NBM-BMX: pulmonary embolism&#xD;
               events, deep vein thrombosis (DVT) events, myocardial infarction, severe/unstable&#xD;
               angina, coronary/peripheral artery bypass graft, congestive heart failure, or&#xD;
               cerebrovascular accident including transient ischemic attack.&#xD;
  &#xD;
            6. A positive test for hepatitis B (HBsAg) and/or hepatitis C (anti-HCV antibody), unless&#xD;
               the HBV DNA level and/or HCV RNA level is below the limit of detection.&#xD;
  &#xD;
            7. Known history of human immunodeficiency virus (HIV) infection. Note: HIV testing is&#xD;
               not required.&#xD;
  &#xD;
            8. Men and women of childbearing potential who are unwilling to use highly effective&#xD;
               contraceptive methods during the study period and for at least 6 months after the&#xD;
               final dose of temozolomide.&#xD;
  &#xD;
               Highly effective contraceptive methods include implants, injectables, combined oral&#xD;
               contraceptives, intra-uterine devices (IUDs), sexual abstinence, surgical&#xD;
               sterilization or a partner who is sterile.&#xD;
  &#xD;
            9. Female who are pregnant or breastfeeding.&#xD;
  &#xD;
           10. Other severe acute or chronic medical or psychiatric condition or laboratory&#xD;
               abnormality that would impart, in the judgement of the investigator and/or sponsor,&#xD;
               excess risks associated with study participation or study drug administration.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Chia-Chung Hou, Ph.D.</last_name>
      <phone>+886 2 26559109</phone>
      <phone_ext>201</phone_ext>
      <email>alison.hou@naturewise.com.tw</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Karis Chiang</last_name>
      <phone>+886 2 27891060</phone>
      <phone_ext>306</phone_ext>
      <email>karis.chiang@effpha.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Hualien Tzu Chi Hospital</name>
        <address>
          <city>Hualien City</city>
          <zip>970</zip>
          <country>Taiwan</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Tsung-Lang Chiu, M.D.</last_name>
        <phone>+886 3 8561825</phone>
      </contact>
    </location>
    <location>
      <facility>
        <name>Kaohsiung Medical University Chung-Ho Memorial Hospital</name>
        <address>
          <city>Kaohsiung City</city>
          <zip>807</zip>
          <country>Taiwan</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Ann-Shung Lieu, M.D.</last_name>
        <phone>+886 7 3121101</phone>
      </contact>
    </location>
    <location>
      <facility>
        <name>Taichung Veterans General Hospital</name>
        <address>
          <city>Taichung City</city>
          <zip>407</zip>
          <country>Taiwan</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Wen-Yu Cheng, M.D.</last_name>
        <phone>+886 4 23592525</phone>
      </contact>
    </location>
    <location>
      <facility>
        <name>Koo Foundation Sun Yat-Sen Cancer Center</name>
        <address>
          <city>Taipei City</city>
          <zip>112</zip>
          <country>Taiwan</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Chi-Feng Chung, M.D.</last_name>
        <phone>+886 2 28970011</phone>
      </contact>
    </location>
    <location>
      <facility>
        <name>Linkou Chang-Gung Memorial Hospital</name>
        <address>
          <city>Taoyuan City</city>
          <zip>333</zip>
          <country>Taiwan</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Kuo-Chen Wei, M.D.</last_name>
        <phone>+886 3 3281200</phone>
      </contact>
    </location>
    <location_countries>
      <country>Taiwan</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 11, 2023</study_first_submitted>
    <study_first_submitted_qc>August 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 25, 2023</study_first_posted>
    <last_update_submitted>August 22, 2023</last_update_submitted>
    <last_update_submitted_qc>August 22, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 25, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Neoplasms</mesh_term>
      <mesh_term>Glioblastoma</mesh_term>
      <mesh_term>Brain Neoplasms</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Temozolomide</mesh_term>
    </intervention_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06012695
  org study id: NBM-BMX-003
  nct id: NCT06012695
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  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.
  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.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: [Arm A, Phase Ib] Frequency of dose-limiting toxicity (DLT) at each dose level
  time frame: up to 28 days
  description: 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.
  measure: [Arm B, Phase Ib] Frequency of dose-limiting toxicity (DLT) at each dose level
  time frame: up to 10 weeks
  description: 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.
  measure: [Arm B, Phase II] Progression-free survival rate at 6 months (PFS6)
  time frame: up to 6 months
  description: 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.
  measure: Frequency, types, severity, and relationship to NBM-BMX of adverse events (AEs)
  time frame: up to 28 days
  description: The severity of AEs will be graded using NCI CTCAE Version 5.0 by the investigator.
  measure: Preliminary assessment of anti-tumor activity by response evaluation criteria
  time frame: at least 8 weeks
  description: Tumor response and progression will be assessed using the RECIST v1.1 or Response Assessment in Neuro-Oncology (RANO) criteria.
  measure: 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)
  description: Blood samples will be collected at each pre-specified time point for measuring concentrations of NBM-BMX in plasma using a validated bioanalytical method.
  measure: Peak plasma concentration (Cmax) of NBM-BMX
  time frame: Day 1, 8 and 15 for Cycle 1 only (each cycle is 28 days)
  description: Blood samples will be collected at each pre-specified time point for measuring concentrations of NBM-BMX in plasma using a validated bioanalytical method.
  measure: 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)
  description: Blood samples will be collected at each pre-specified time point for measuring concentrations of NBM-BMX in plasma using a validated bioanalytical method.
  measure: 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)
  description: Blood samples will be collected at each pre-specified time point for measuring concentrations of NBM-BMX in plasma using a validated bioanalytical method.
  arm group label: monotherapy in advanced solid tumors
  arm group type: Experimental
  description: Subjects with advanced solid tumors will be treated with NBM-BMX monotherapy at different dose levels depending on the order of their enrollment.
  arm group label: combination therapy in newly diagnosed glioblastoma
  arm group type: Experimental
  description: 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.
  intervention type: Drug
  intervention name: NBM-BMX Capsule
  description: Each capsule contains 100 mg of the active ingredient.
  arm group label: combination therapy in newly diagnosed glioblastoma
  arm group label: monotherapy in advanced solid tumors
  intervention type: Drug
  intervention name: Temozolomide
  description: 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.
  arm group label: combination therapy in newly diagnosed glioblastoma
  other name: Temodal® Capsules
  intervention type: Radiation
  intervention name: Standard radiotherapy
  description: A total dose of 60 Gy will be administered in 6 weeks.
  arm group label: combination therapy in newly diagnosed glioblastoma
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Chia-Chung Hou, Ph.D.
  phone: +886 2 26559109
  phone ext: 201
  email: alison.hou@naturewise.com.tw
  last name: Karis Chiang
  phone: +886 2 27891060
  phone ext: 306
  email: karis.chiang@effpha.com
  facility: 
  status: Not yet recruiting
  contact: 
  facility: 
  status: Not yet recruiting
  contact: 
  facility: 
  status: Not yet recruiting
  contact: 
  facility: 
  status: Not yet recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  country: Taiwan
  responsible party type: Sponsor
  mesh term: Neoplasms
  mesh term: Glioblastoma
  mesh term: Brain Neoplasms
  mesh term: Temozolomide