<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/NCT02994498</url>
  </required_header>
  <id_info>
    <org_study_id>CMB-B01</org_study_id>
    <nct_id>NCT02994498</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy of DCB-BO1301 in Advanced Melanoma</brief_title>
  <official_title>An Open-Label Phase I/IIa Dose-Escalation Study Evaluating the Safety, Tolerability and Efficacy of DCB-BO1301 as Add-on Therapy to Dacarbazine in Subjects With Advanced Melanoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chung Mei Biopharma Co., Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chung Mei Biopharma Co., Ltd</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The primary study objectives are&#xD;
&#xD;
        1. to evaluate the safety and tolerability profiles of DCB-BO1301 and to determine the&#xD;
           maximum tolerated dose (MTD) of DCB-BO1301 as add-on therapy to dacarbazine in subjects&#xD;
           with advanced melanoma (Phase I)&#xD;
&#xD;
        2. to evaluate the efficacy profile of DCB-BO1301 at MTD or lower dose level as add-on&#xD;
           therapy to dacarbazine in subjects with advanced melanoma in terms of progression free&#xD;
           survival (Phase IIa)&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">March 2023</start_date>
  <completion_date type="Anticipated">December 2025</completion_date>
  <primary_completion_date type="Anticipated">September 2025</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>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Maximum tolerated dose</measure>
    <time_frame>Week 6</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of adverse events</measure>
    <time_frame>Weeks 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 52</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Response rate</measure>
    <time_frame>Weeks 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 52</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>Weeks 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 52, 64, 76</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in global health/QoL standardized score at post-treatment visits compared to baseline.</measure>
    <time_frame>Weeks 0, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 52</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression free survival</measure>
    <time_frame>Weeks 0, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 52, 64,76</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">33</enrollment>
  <condition>Advanced Melanoma</condition>
  <arm_group>
    <arm_group_label>DCB-BO1301 1 capsule</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>DCB-BO1301 1 capsule, tid (around 1 hour before meal) for at most 48 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>DCB-BO1301 2 capsules</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>DCB-BO1301 2 capsules, tid (around 1 hour before meal) for at most 48 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>DCB-BO1301 3 capsules</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>DCB-BO1301 3 capsules, tid (around 1 hour before meal) for at most 48 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>DCB-BO1301</intervention_name>
    <description>1, 2, or 3 capsules, three times a day, oral, at most 48 weeks</description>
    <arm_group_label>DCB-BO1301 1 capsule</arm_group_label>
    <arm_group_label>DCB-BO1301 2 capsules</arm_group_label>
    <arm_group_label>DCB-BO1301 3 capsules</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subjects ≧ 20 years old (inclusive)&#xD;
&#xD;
          2. Histologically or cytologically confirmed advanced melanoma, (stage III or IV)&#xD;
&#xD;
          3. Subject must have at least one of the following:&#xD;
&#xD;
               -  Melanoma that was previously treated with at least one complete or partial course&#xD;
                  of therapy for melanoma with either a poor to no response or evidence of disease&#xD;
                  progression;&#xD;
&#xD;
               -  Melanoma that cannot be treated with first-line therapies because of medical&#xD;
                  comorbidities/risk of toxicity; or&#xD;
&#xD;
               -  Melanoma that has not been treated with first-line therapies because of patient&#xD;
                  refusal.&#xD;
&#xD;
          4. If melanoma is possibly resectable, the melanoma must have recurred despite at least&#xD;
             two attempts at resection.&#xD;
&#xD;
          5. Evaluable disease, at least one measurable target lesion on imaging by RECIST 1.1&#xD;
             criteria on previous scan&#xD;
&#xD;
          6. ECOG performance status ≤ 2 and life expectancy ≥ 3 months Note: ECOG = Eastern&#xD;
             Cooperative Oncology Group&#xD;
&#xD;
          7. Females subjects must be either&#xD;
&#xD;
               -  of non-childbearing potential:&#xD;
&#xD;
               -  Or, if of childbearing potential:&#xD;
&#xD;
                    -  Must have a negative urine or serum pregnancy test at screening, and&#xD;
&#xD;
                    -  If heterosexually active, must use at least 1 form of birth control (which&#xD;
                       must be a barrier method) starting at screening and through the primary&#xD;
                       study period.&#xD;
&#xD;
          8. Female subject must not be breastfeeding at screening, through the treatment period&#xD;
             and through the primary study period.&#xD;
&#xD;
          9. Male subject and their female spouse/partners who are of childbearing potential must&#xD;
             be using highly effective contraception consisting of 2 forms of birth control (1 of&#xD;
             which must be a barrier method) starting at screening, through the treatment period&#xD;
             and through the primary study period.&#xD;
&#xD;
         10. Dated and signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Primary CNS malignancies or clinically active CNS metastases&#xD;
&#xD;
          2. Ascertained hypersensitivity to any component of investigational product or standard&#xD;
             therapies that the subject will be treated&#xD;
&#xD;
          3. Any of the following hematologic abnormalities:&#xD;
&#xD;
               1. Hemoglobin &lt; 10 g/dL,&#xD;
&#xD;
               2. ANC &lt; 1,500/μL,&#xD;
&#xD;
               3. Platelets &lt; 75,000 /μL Note: ANC = absolute neutrophil count&#xD;
&#xD;
          4. Any of the following serum chemistry abnormalities:&#xD;
&#xD;
               1. Total bilirubin &gt; 1.5 × ULN,&#xD;
&#xD;
               2. AST, ALT, or Alk-P &gt; 2.5 × ULN,&#xD;
&#xD;
               3. serum albumin &lt; 2.5 g/dL,&#xD;
&#xD;
               4. creatinine &gt; 1.5 × ULN,&#xD;
&#xD;
               5. creatine phosphokinase (CPK) &gt; 2.5 × ULN,&#xD;
&#xD;
             d. any other ≥ Grade 3 laboratory abnormality at baseline (other than those listed&#xD;
             above) Note: ULN = upper limit of normal. AST = aspartate transaminase, ALT = alanine&#xD;
             transaminase&#xD;
&#xD;
          5. History of known brain metastases&#xD;
&#xD;
          6. Anticipated requiring, being taking, or taken with past 2 weeks of Screening visit of&#xD;
             systemic steroid, immunosuppressive agents, aspirin (more than 100 mg/day), NSAID&#xD;
             (except COX-2 Inhibitors), heparin, low molecular weight heparin or warfarin (more&#xD;
             than 1 mg/day) Note: NSAID = Nonsteroidal anti-inflammatory drugs&#xD;
&#xD;
          7. Uncontrolled nausea or vomiting or any symptom that would prevent the ability to&#xD;
             comply with daily oral DCB-BO1301 treatment&#xD;
&#xD;
          8. Serious/active infection such as HIV, HBV or HCV carrier, or infection requiring&#xD;
             parenteral antibiotics Note: HIV = Human immunodeficiency virus; HBV = Hepatitis B&#xD;
             virus; HCV = hepatitis C virus&#xD;
&#xD;
          9. Uncontrolled psychiatric disorder or altered mental status precluding informed consent&#xD;
             or necessary testing&#xD;
&#xD;
         10. Consumption of herbal preparations/supplements (except for a daily&#xD;
             multivitamin/mineral supplement not containing herbal components) within 2 weeks prior&#xD;
             to the start of DCB-BO1301 administration&#xD;
&#xD;
         11. Significant cardiovascular disease, including:&#xD;
&#xD;
               1. Active clinically symptomatic left ventricular failure&#xD;
&#xD;
               2. Active hypertension (diastolic blood pressure &gt; 100 mmHg). Subjects with a&#xD;
                  history of hypertension must have been on stable doses of anti-hypertensive drugs&#xD;
                  for ≥ 4 weeks prior to start of DCB-BO1301 administration&#xD;
&#xD;
               3. Uncontrolled hypertension: Blood pressure &gt;140/90 mmHg on more than 2&#xD;
                  antihypertensive medications&#xD;
&#xD;
               4. Myocardial infarction within 3 months prior to the start of DCB-BO1301&#xD;
                  administration&#xD;
&#xD;
               5. Prothrombin time &gt; 1.5 x ULN; APTT abnormal (&lt; 20 sec or &gt; 34 sec) ; long QT&#xD;
                  syndrome&#xD;
&#xD;
         12. Significant gastrointestinal disorder(s) that would, in the opinion of the&#xD;
             investigator, prevent absorption of an orally available agent&#xD;
&#xD;
         13. Has received an investigational agent within 4 weeks of entering this study&#xD;
&#xD;
         14. With any condition judged by the investigator that entering the trial may be&#xD;
             detrimental to the subject&#xD;
&#xD;
         15. Receiving chemotherapy, investigational or hormonal therapy, major surgeries in the&#xD;
             previous 4 weeks of Screening visit.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Leon YZ Zhan, MS</last_name>
    <phone>+886-4-2329-0578</phone>
    <phone_ext>511</phone_ext>
    <email>Leon.Zhan@cm-biopha.com</email>
  </overall_contact>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>December 9, 2016</study_first_submitted>
  <study_first_submitted_qc>December 13, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 16, 2016</study_first_posted>
  <last_update_submitted>March 17, 2022</last_update_submitted>
  <last_update_submitted_qc>March 17, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 18, 2022</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>Melanoma</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT02994498
org study id: CMB-B01
nct id: NCT02994498
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The primary study objectives are

        1. to evaluate the safety and tolerability profiles of DCB-BO1301 and to determine the
           maximum tolerated dose (MTD) of DCB-BO1301 as add-on therapy to dacarbazine in subjects
           with advanced melanoma (Phase I)

        2. to evaluate the efficacy profile of DCB-BO1301 at MTD or lower dose level as add-on
           therapy to dacarbazine in subjects with advanced melanoma in terms of progression free
           survival (Phase IIa)
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Maximum tolerated dose
time frame: Week 6
measure: Incidence of adverse events
time frame: Weeks 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 52
measure: Response rate
time frame: Weeks 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 52
measure: Overall survival
time frame: Weeks 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 52, 64, 76
measure: Changes in global health/QoL standardized score at post-treatment visits compared to baseline.
time frame: Weeks 0, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 52
measure: Progression free survival
time frame: Weeks 0, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 52, 64,76
arm group label: DCB-BO1301 1 capsule
arm group type: Experimental
description: DCB-BO1301 1 capsule, tid (around 1 hour before meal) for at most 48 weeks
arm group label: DCB-BO1301 2 capsules
arm group type: Experimental
description: DCB-BO1301 2 capsules, tid (around 1 hour before meal) for at most 48 weeks
arm group label: DCB-BO1301 3 capsules
arm group type: Experimental
description: DCB-BO1301 3 capsules, tid (around 1 hour before meal) for at most 48 weeks
intervention type: Drug
intervention name: DCB-BO1301
description: 1, 2, or 3 capsules, three times a day, oral, at most 48 weeks
arm group label: DCB-BO1301 1 capsule
arm group label: DCB-BO1301 2 capsules
arm group label: DCB-BO1301 3 capsules
criteria: 
gender: All
minimum age: 20 Years
maximum age: 75 Years
healthy volunteers: No
last name: Leon YZ Zhan, MS
phone: +886-4-2329-0578
phone ext: 511
email: Leon.Zhan@cm-biopha.com
responsible party type: Sponsor
mesh term: Melanoma