<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/NCT04448379</url>
  </required_header>
  <id_info>
    <org_study_id>JMT101-CSP-001</org_study_id>
    <nct_id>NCT04448379</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of JMT101 Combined With Afatinib (or Osimertinib) in Patients With Non-Small Cell Lung Cancer</brief_title>
  <official_title>A Phase Ib,Open Label,Multi-center Study to Assess the Efficacy and Safety of JMT101 Combined With Afatinib (or Osimertinib) in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer With EGFR Exon 20 Insertion Mutations</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai JMT-Bio Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>CSPC ZhongQi Pharmaceutical Technology Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Shanghai JMT-Bio Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is a Phase Ib, open label, multi-center study of to evaluate the safety and&#xD;
      efficacy of JMT101 combined with EGFR-TKIs (Afatinib or Osimertinib) in patients with locally&#xD;
      advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion&#xD;
      mutations.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objective of the trial is to evaluate the safety and efficacy of JMT101 combined with&#xD;
      EGFR-TKIs (afatinib or osimertinib) in patients with locally advanced or metastatic NSCLC&#xD;
      with EGFR exon 20 insertion mutations.&#xD;
&#xD;
      This study consists of two parts (Stage I and Stage II). Stage I was a dose escalation study,&#xD;
      and Stage II was a dose expansion study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 29, 2020</start_date>
  <completion_date type="Anticipated">June 30, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2021</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of adverse events (defined by the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE V5.0)).</measure>
    <time_frame>From enrollment until 30 days after the last dose</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Objective Response Rate (ORR) Assessed by Blinded Independent Review Committee (IRC) per RECIST Version 1.1</measure>
    <time_frame>From first dose to disease progression or end of study, an average of 1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease control rate (DCR).</measure>
    <time_frame>From first dose to disease progression or end of study, an average of 1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression free survival (PFS).</measure>
    <time_frame>From first dose to disease progression or end of study, an average of 1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival (OS).</measure>
    <time_frame>From first dose to death or end of study, an average of 1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the concentration curve from time 0 to the concentration at last time point (AUC0-last) of JMT101.</measure>
    <time_frame>From enrollment until 30 days after the last dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum measured plasma concentration (Cmax) of JMT101.</measure>
    <time_frame>From enrollment until 30 days after the last dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to maximum plasma concentration (Tmax) of JMT101.</measure>
    <time_frame>From enrollment until 30 days after the last dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Half-life (T1/2) of JMT101.</measure>
    <time_frame>From enrollment until 30 days after the last dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Immunogenicity profile of JMT101.</measure>
    <time_frame>From enrollment until 30 days after the last dose</time_frame>
    <description>Blood samples will be collected from subjects post treatment for assessment to detect the presence of anti-drug antibodies and neutralizing antibodies.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Potential biomarkers detected in plasma circulating tumor DNA.</measure>
    <time_frame>From enrollment up to disease progression, an average of 1 year</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">48</enrollment>
  <condition>Locally Advanced or Metastatic Non-Small Cell Lung Cancer</condition>
  <arm_group>
    <arm_group_label>Dose Escalation Cohort</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Two dose levels of JMT101 combined with afatinib or osimertinib will be tested according to the &quot;3 + 3&quot; dose-escalation design.&#xD;
The dose-limiting toxicity (DLT) will be assessed from the first administration to the end of the first cycle (28 days).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dose Expansion Cohort</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Once the effective dose has been determined, an expansion cohort will be opened to evaluate the efficacy and safety of the selected dose.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>JMT101</intervention_name>
    <description>IV infusion Q2W for 4 weeks (28-day cycles)</description>
    <arm_group_label>Dose Escalation Cohort</arm_group_label>
    <arm_group_label>Dose Expansion Cohort</arm_group_label>
    <other_name>Afatinib or Osimertinib</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pathologically or cytologically confirmed, locally advanced or metastatic NSCLC,&#xD;
             harboring an EGFR exon 20 insertion mutation. ( non-irradiable, non-operable);&#xD;
&#xD;
          -  No previous treatment or first-line treatment failed NSCLC;&#xD;
&#xD;
          -  At least 1 measurable lesion according to RECIST 1.1;&#xD;
&#xD;
          -  ECOG score 0 or 1;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previously treated with EGFR antibody;&#xD;
&#xD;
          -  Symptomatic brain metastasis;&#xD;
&#xD;
          -  Interstitial pneumopathy;&#xD;
&#xD;
          -  Known hypersensitivity to any ingredient of JMT101, afatinib, osimertinib or their&#xD;
             excipients;&#xD;
&#xD;
          -  Receiving an investigational product in another clinical study within 4 weeks;&#xD;
&#xD;
          -  History of serious systemic diseases;&#xD;
&#xD;
          -  History of serious autoimmune diseases;&#xD;
&#xD;
          -  Pregnancy or lactating women.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Xiugao Yang</last_name>
    <phone>8021-60677906</phone>
    <email>yangxiugao@mail.ecspc.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Rong Hu</last_name>
    <phone>8021-60673935</phone>
    <email>hurong@mail.ecspc.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Sun Yat-sen University Cancer Center</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510060</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Li Zhang</last_name>
      <phone>8020-87343458</phone>
      <email>zhangli@sysucc.org.cn</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>The Fourth Hospital of Hebei Medical University</name>
      <address>
        <city>Shijiazhuang</city>
        <state>Hebei</state>
        <zip>050000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Da Jiang</last_name>
      <phone>80311-86095588</phone>
      <email>jiangda139@163.com</email>
    </contact>
    <contact_backup>
      <last_name>Mingxia Wang</last_name>
      <phone>80311-66696233</phone>
      <email>hb4thgcp@126.com</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Chinese Pla General Hospital</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yi Hu</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hunan Cancer Hospital</name>
      <address>
        <city>Changsha</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lin Wu</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>West China Hospital of Sichuan University</name>
      <address>
        <city>Chengdu</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Feng Luo</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Fujian Cancer Hospital</name>
      <address>
        <city>Fuzhou</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Wu Zhuang</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Zhejiang Cancer Hospital</name>
      <address>
        <city>Hangzhou</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yiping Zhang</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Jiangsu Province Hospital of Chinese Medicine</name>
      <address>
        <city>Nanjing</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Qian Wang</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School</name>
      <address>
        <city>Nanjing</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Liyun Miao</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Shanghai Chest Hospital, Shanghai Jiaotong University</name>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Baohui Han</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Shanxi Bethune Hospital (Shanxi Academy of Medical Sciences)</name>
      <address>
        <city>Taiyuan</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Junping Zhang</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Shanxi Province Cancer Hospital</name>
      <address>
        <city>Taiyuan</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Wei Guo</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Union Hospital, affiliated with TongJi Medical College, HuaZhong University of Science and Technology</name>
      <address>
        <city>Wuhan</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xiaorong Dong</last_name>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 16, 2020</study_first_submitted>
  <study_first_submitted_qc>June 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 25, 2020</study_first_posted>
  <last_update_submitted>December 23, 2020</last_update_submitted>
  <last_update_submitted_qc>December 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 28, 2020</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>Lung Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Non-Small-Cell Lung</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osimertinib</mesh_term>
    <mesh_term>Afatinib</mesh_term>
  </intervention_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/NCT04448379
org study id: JMT101-CSP-001
nct id: NCT04448379
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study is a Phase Ib, open label, multi-center study of to evaluate the safety and
      efficacy of JMT101 combined with EGFR-TKIs (Afatinib or Osimertinib) in patients with locally
      advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion
      mutations.
The objective of the trial is to evaluate the safety and efficacy of JMT101 combined with
      EGFR-TKIs (afatinib or osimertinib) in patients with locally advanced or metastatic NSCLC
      with EGFR exon 20 insertion mutations.

      This study consists of two parts (Stage I and Stage II). Stage I was a dose escalation study,
      and Stage II was a dose expansion study.
allocation: Non-Randomized
intervention model: Sequential Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Incidence of adverse events (defined by the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE V5.0)).
time frame: From enrollment until 30 days after the last dose
measure: Objective Response Rate (ORR) Assessed by Blinded Independent Review Committee (IRC) per RECIST Version 1.1
time frame: From first dose to disease progression or end of study, an average of 1 year
measure: Disease control rate (DCR).
time frame: From first dose to disease progression or end of study, an average of 1 year
measure: Progression free survival (PFS).
time frame: From first dose to disease progression or end of study, an average of 1 year
measure: Overall survival (OS).
time frame: From first dose to death or end of study, an average of 1 year
measure: Area under the concentration curve from time 0 to the concentration at last time point (AUC0-last) of JMT101.
time frame: From enrollment until 30 days after the last dose
measure: Maximum measured plasma concentration (Cmax) of JMT101.
time frame: From enrollment until 30 days after the last dose
measure: Time to maximum plasma concentration (Tmax) of JMT101.
time frame: From enrollment until 30 days after the last dose
measure: Half-life (T1/2) of JMT101.
time frame: From enrollment until 30 days after the last dose
measure: Immunogenicity profile of JMT101.
time frame: From enrollment until 30 days after the last dose
description: Blood samples will be collected from subjects post treatment for assessment to detect the presence of anti-drug antibodies and neutralizing antibodies.
measure: Potential biomarkers detected in plasma circulating tumor DNA.
time frame: From enrollment up to disease progression, an average of 1 year
arm group label: Dose Escalation Cohort
arm group type: Experimental
description: Two dose levels of JMT101 combined with afatinib or osimertinib will be tested according to the "3 + 3" dose-escalation design.
The dose-limiting toxicity (DLT) will be assessed from the first administration to the end of the first cycle (28 days).
arm group label: Dose Expansion Cohort
arm group type: Experimental
description: Once the effective dose has been determined, an expansion cohort will be opened to evaluate the efficacy and safety of the selected dose.
intervention type: Drug
intervention name: JMT101
description: IV infusion Q2W for 4 weeks (28-day cycles)
arm group label: Dose Escalation Cohort
arm group label: Dose Expansion Cohort
other name: Afatinib or Osimertinib
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Xiugao Yang
phone: 8021-60677906
email: yangxiugao@mail.ecspc.com
last name: Rong Hu
phone: 8021-60673935
email: hurong@mail.ecspc.com
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
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status: Recruiting
contact: 
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status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
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status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Lung Neoplasms
mesh term: Carcinoma, Non-Small-Cell Lung
mesh term: Osimertinib
mesh term: Afatinib