<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/NCT03781219</url>
  </required_header>
  <id_info>
    <org_study_id>HL-085-102</org_study_id>
    <nct_id>NCT03781219</nct_id>
  </id_info>
  <brief_title>A PhaseI Study of HL-085 Plus Vemurafenib in Solid Tumor With BRAF V600 Mutation</brief_title>
  <official_title>A Phase I, Single Arm, Dose Escalation Study to Evaluate Safety, Pharmacokinetics and Preliminary Efficacy of HL-085 Plus Vemurafenib in Patients With BRAF V600 Mutant Advanced Solid Tumor</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai Kechow Pharma, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shanghai Kechow Pharma, Inc.</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a phase I, open-label, dose escalation study to evaluate tolerability, safety,&#xD;
      pharmacokinetics and efficacy in patients with BRAF V600 mutant advanced solid tumor by&#xD;
      HL-085 plus Vemurafenib treatment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 1, 2018</start_date>
  <completion_date type="Anticipated">December 1, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2023</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <intervention_model_description>If no Dose-limiting toxicity (DLT) occurs in the first three subjects in Cycle 1, the dose will be escalated to the next dose level; If a DLT occurs in one of the first three subjects, three additional subjects will be enrolled for the same dose cohort, and undergo the same procedures. Dose -escalation is performed based on the scheduled dose groups until DLT occurs in two or more subjects in a dose group which consists of 3 or 6 subjects.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Adverse Events</measure>
    <time_frame>up to 12 mouths</time_frame>
    <description>Number of Treatment-Related Adverse Events as Assessed by CTCAE v4.03 will be counted.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">45</enrollment>
  <condition>Solid Tumor</condition>
  <arm_group>
    <arm_group_label>HL-085 plus Vemurafenib</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>HL-085 will be administered as BID with specified dose. And the Vemurafenib will be taken as the instruction in the label ( 960 mg, BID)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>HL-085</intervention_name>
    <description>HL-085 ( Capsule) is one MEK inhibitor.</description>
    <arm_group_label>HL-085 plus Vemurafenib</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vemurafenib</intervention_name>
    <description>Vemurafenib ( Tablet) is BRAF inhibitor,</description>
    <arm_group_label>HL-085 plus Vemurafenib</arm_group_label>
    <other_name>ZELBORAF</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. BRAF V600 mutation in solid tumor.&#xD;
&#xD;
          2. One measurable lesion as defined by RECIST 1.1 criteria for solid tumors.&#xD;
&#xD;
          3. Chemotherapy, immunotherapy or radiotherapy ≥ 4 weeks prior to starting the study&#xD;
             treatment.&#xD;
&#xD;
          4. Surgery (except for tumor biopsy) or severe trauma ≤ 14 days prior to starting the&#xD;
             study treatment.&#xD;
&#xD;
          5. ECOG performance status of 0-1.&#xD;
&#xD;
          6. Life expectancy ≥ 3 months.&#xD;
&#xD;
          7. Ability to take the medicine orally.&#xD;
&#xD;
          8. Ability to understand and the willingness to sign a written informed consent document.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Hypersensitivity to study drug ingredients or their analogues.&#xD;
&#xD;
          2. Prior therapy with MEK-inhibitor.&#xD;
&#xD;
          3. Receiving any other anti-cancer therapy at the same time .&#xD;
&#xD;
          4. Active central nervous system (CNS) lesion.&#xD;
&#xD;
          5. Bleeding symptoms at Grade 3 within 4 weeks prior to starting study treatment.&#xD;
&#xD;
          6. ECG QTcB≥480msec in screening, or history of congenital long QT syndrome；&#xD;
&#xD;
          7. Uncontrolled concomitant diseases or infectious diseases.&#xD;
&#xD;
          8. Retinal diseases (Retinal Vein Occlusion (RVO) or Retinal pigment epithelial&#xD;
             detachment (RPED) , et al.).&#xD;
&#xD;
          9. History of HIV,HCV,HBV infection.&#xD;
&#xD;
         10. Interstitial lung disease or interstitial pneumonitis, including clinically&#xD;
             significant radiation pneumonitis will be excluded.&#xD;
&#xD;
         11. Serum HCG test is positive.&#xD;
&#xD;
         12. Other conditions that increase the risk of study and influence the result.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hongqi Tian, Ph.D</last_name>
    <role>Study Director</role>
    <affiliation>Shanghai Kechow Pharma, Inc.</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jin Ma, Bachelor</last_name>
    <phone>86 13810268600</phone>
    <email>maj@kechowpharma.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Cancer Hospital Chinese Academy of Medical Science</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100021</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yuankai Shi, M.D</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Beijing Oncology Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Henan Province Oncology Hospital</name>
      <address>
        <city>Zhengzhou</city>
        <state>Henan</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>First Affiliated Hospital, Medicine School of Zhejiang University</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>March 1, 2018</study_first_submitted>
  <study_first_submitted_qc>December 17, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>May 29, 2023</last_update_submitted>
  <last_update_submitted_qc>May 29, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 31, 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>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vemurafenib</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03781219
org study id: HL-085-102
nct id: NCT03781219
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This is a phase I, open-label, dose escalation study to evaluate tolerability, safety,
      pharmacokinetics and efficacy in patients with BRAF V600 mutant advanced solid tumor by
      HL-085 plus Vemurafenib treatment.
allocation: N/A
intervention model: Sequential Assignment
intervention model description: If no Dose-limiting toxicity (DLT) occurs in the first three subjects in Cycle 1, the dose will be escalated to the next dose level; If a DLT occurs in one of the first three subjects, three additional subjects will be enrolled for the same dose cohort, and undergo the same procedures. Dose -escalation is performed based on the scheduled dose groups until DLT occurs in two or more subjects in a dose group which consists of 3 or 6 subjects.
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Adverse Events
time frame: up to 12 mouths
description: Number of Treatment-Related Adverse Events as Assessed by CTCAE v4.03 will be counted.
arm group label: HL-085 plus Vemurafenib
arm group type: Experimental
description: HL-085 will be administered as BID with specified dose. And the Vemurafenib will be taken as the instruction in the label ( 960 mg, BID)
intervention type: Drug
intervention name: HL-085
description: HL-085 ( Capsule) is one MEK inhibitor.
arm group label: HL-085 plus Vemurafenib
intervention type: Drug
intervention name: Vemurafenib
description: Vemurafenib ( Tablet) is BRAF inhibitor,
arm group label: HL-085 plus Vemurafenib
other name: ZELBORAF
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Hongqi Tian, Ph.D
role: Study Director
affiliation: Shanghai Kechow Pharma, Inc.
last name: Jin Ma, Bachelor
phone: 86 13810268600
email: maj@kechowpharma.com
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
country: China
responsible party type: Sponsor
mesh term: Neoplasms
mesh term: Vemurafenib
sharing ipd: Undecided