<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/NCT04425070</url>
  </required_header>
  <id_info>
    <org_study_id>ATG-010-T/NK-001</org_study_id>
    <nct_id>NCT04425070</nct_id>
  </id_info>
  <brief_title>A Study of Evaluating the Safety and Efficacy of ATG-010 Combined With Chemotherapy Sequential With ATG-010 Monotherapy Maintenance in Peripheral T- and NK/T-cell Lymphoma</brief_title>
  <acronym>TOUCH</acronym>
  <official_title>A Phase 1/2, Open-label, Multi-center Study to Evaluate theSafety and Efficacy of Selinexor Combined With Chemotherapy orTislelizumab in Relapsed or Refractory Mature T and NK Cell Lymphoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Antengene Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Antengene Corporation</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 trial is proposed with treatment of ATG-010 combined with chemotherapy regimens which&#xD;
      will be chosen by investigators (ICE [ifosfamide+carboplatin+etoposide] or GEMOX&#xD;
      [gemcitabine+oxaliplatin] or Tislelizumab), after treatments of 2 to 6 cycles transferring to&#xD;
      ATG-010 monotherapy maintenance treatment, to evaluate the safety, tolerability, and primary&#xD;
      efficacy of ATG-010 in R/R PTCL and NK/T-cell lymphoma patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This trial is an open-label, multi-center Phase Ib clinical study that will evaluate ATG-010&#xD;
      combined with chemotherapy regimen selected by investigators (ICE regimen&#xD;
      ifosfamide+carboplatin+etoposide; Or GEMOX regimen: gemcitabine+oxaliplatin; Tislelizumab)&#xD;
      sequential ATG 010 monotherapy maintenance, to evaluate the safety, tolerability, and primary&#xD;
      efficacy in R/R PTCL and NK/T-cell lymphoma patients. 97 patients are planned to be enrolled.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 18, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</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>
    <intervention_model_description>ATG-010 + ICE ATG-010 + GEMOX ATG-010 + Tislelizumab</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>AEs/SAEs</measure>
    <time_frame>18 months</time_frame>
    <description>Toxicity will be graded according to the NCI CTCAE, Version 5.0.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall Response Rate (ORR)</measure>
    <time_frame>18 months</time_frame>
    <description>To determine the overall response rate according to Chenson 2014.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Duration of response (DOR)</measure>
    <time_frame>18 months</time_frame>
    <description>Duration of time from first occurrence of CR or PR until the first date that disease progression is objectively documented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease control rate (DCR)</measure>
    <time_frame>4 weeks to 18 months</time_frame>
    <description>Proportion of patients who achieve CR, PR, or SD for a minimum of 4 weeks, following the first dose of study drug (i.e., CR+PR+SD)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression-free survival (PFS)</measure>
    <time_frame>18 months</time_frame>
    <description>Duration of time from the first dose of study drug until progression or death due to any cause</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival (OS)</measure>
    <time_frame>18 months</time_frame>
    <description>Duration of time from the first dose of study drug until death due to any cause</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">97</enrollment>
  <condition>Peripheral T-cell Lymphoma</condition>
  <condition>NK/T-cell Lymphoma</condition>
  <arm_group>
    <arm_group_label>ATG-010 + ICE</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ATG-010 60 mg/once,total twice in each cycle; on Days 4 and 11</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ATG-010 + GEMOX</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ATG-010 60 mg/once,total twice in each cycle; on Days 2 and 9</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ATG-010 + Tislelizumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ATG 010 40mg/once, will be given on Days 1, 8, and 15 of each cycle</description>
  </arm_group>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>ICE [ifosfamide+carboplatin+etoposide]</intervention_name>
    <description>• Combined with ICE chemotherapy regimen:&#xD;
Ifosfamide: 5 g/m2, continuous intravenous (iv) infusion (mesna 5 g/m2 synchronously iv infusion for rescue), on Day 2;&#xD;
Carboplatin: with concentration-area under time curve (AUC)=5 (highest concentration to 800 mg), iv infusion, on Day 2;&#xD;
Etoposide l00 mg/m2, iv infusion, on Days 1-3;&#xD;
ATG-010 60 mg/once, oral, on Days 4 and 11. After the treatment with combination chemotherapy, the patients will continue to receive maintenance treatment of ATG-010 60 mg/once per week (QW).</description>
    <arm_group_label>ATG-010 + ICE</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>GEMOX [gemcitabine+oxaliplatin]</intervention_name>
    <description>• Combined with GEMOX chemotherapy regimen:&#xD;
Gemcitabine 1000 mg/m2, iv infusion, on Days 1 and 8;&#xD;
Oxaliplatin 130 mg/m2, iv infusion, on Day 1;&#xD;
ATG-010 60 mg/once, oral, on Days 2 and 9. After the treatment with combination chemotherapy, the patients will continue to receive maintenance treatment of ATG-010 60 mg/once per week (QW).</description>
    <arm_group_label>ATG-010 + GEMOX</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>Tislelizumab</intervention_name>
    <description>Tislelizumab will be administered intravenously at a fixed dose of 2 0 0 mg every 3 weeks on Day 1 of each cycle</description>
    <arm_group_label>ATG-010 + Tislelizumab</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. The patient is willing to provide written ICF.&#xD;
&#xD;
          2. Age≥ 18 years.&#xD;
&#xD;
          3. R/R PTCL and NK/T-cell lymphoma as confirmed by histological methods according to WHO&#xD;
             classification of tumors of lymphoid tissues 2016.&#xD;
&#xD;
          4. Previously received at least one or more standard regimens including anthracycline.&#xD;
&#xD;
          5. Recurrence or the recurrence disease after the last treatment completed.&#xD;
&#xD;
          6. At least one measurable disease per modified efficacy assessment criteria (Cheson&#xD;
             2014).&#xD;
&#xD;
          7. ECOG PS 0 or 1.&#xD;
&#xD;
          8. Any toxicity caused by previously anti-tumor therapy must recovered to ≤ Grade 1&#xD;
             (NCI-CTCAE v5.0) with exception of hearing loss, alopecia, and pigmentation.&#xD;
&#xD;
          9. Expected life time longer than 3 months.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Current have disease or history of central nervous system lymphoma.&#xD;
&#xD;
          2. HBV-DNA positive, or HCV-RNA positive.&#xD;
&#xD;
          3. Patients with a known history of human immunodeficiency virus (HIV) infection and/or&#xD;
             acquired immunodeficiency syndrome.&#xD;
&#xD;
          4. Received major surgery within 4 weeks of first dose of study drug&#xD;
&#xD;
          5. Known received SINE, including ATG-010.&#xD;
&#xD;
          6. Unable to swallow the tablets, suffers from malabsorption syndrome, or any other&#xD;
             gastrointestinal disease or dysfunction that may interfere with ATG-010 absorption.&#xD;
&#xD;
          7. Known allergy to ATG-010, or ICE, or GEMOX.&#xD;
&#xD;
          8. A woman who is pregnant or nursing.&#xD;
&#xD;
          9. The investigator considerations on patient's complications or other conditions may&#xD;
             affect protocol compliance or may be inappropriate for participation in the study.&#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_official>
    <last_name>Sai Lou, MD</last_name>
    <role>Study Director</role>
    <affiliation>Medical Director</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Yang Yu, MD</last_name>
    <role>Study Director</role>
    <affiliation>Medical Director</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sunny He, M.D.</last_name>
    <phone>13701803117</phone>
    <email>sunny.he@antengene.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Sara Wang</last_name>
    <phone>17601350610</phone>
    <email>sara.wang@antengene.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Anhui Provincial Cancer Hospital</name>
      <address>
        <city>Hefei</city>
        <state>Anhui</state>
        <zip>230031</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Suspended</status>
  </location>
  <location>
    <facility>
      <name>Beijing Tongren Hospital.CMU</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100005</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Suspended</status>
  </location>
  <location>
    <facility>
      <name>Peking University Third Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100191</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Suspended</status>
  </location>
  <location>
    <facility>
      <name>Chongqing University Cancer Hospital</name>
      <address>
        <city>Chongqing</city>
        <state>Chongqing</state>
        <zip>400030</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Suspended</status>
  </location>
  <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>
    <investigator>
      <last_name>Huiqiang Huang, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Guangxi Medical University Cancer Hospital</name>
      <address>
        <city>Nanning</city>
        <state>Guangxi</state>
        <zip>530021</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Suspended</status>
  </location>
  <location>
    <facility>
      <name>Henan Cancer Hospital</name>
      <address>
        <city>Zhengzhou</city>
        <state>Henan</state>
        <zip>450008</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Suspended</status>
  </location>
  <location>
    <facility>
      <name>Hubei Cancer Hospital</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <zip>430079</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Suspended</status>
  </location>
  <location>
    <facility>
      <name>Jiangsu Cancer Hospital</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Suspended</status>
  </location>
  <location>
    <facility>
      <name>Jiangsu Province Hospital</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210029</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Suspended</status>
  </location>
  <location>
    <facility>
      <name>Jilin Cancer Hospital</name>
      <address>
        <city>Changchun</city>
        <state>Jilin</state>
        <country>China</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Fudan University Shanghai Cancer Center</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200032</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sara Wang, CTM</last_name>
    </contact>
    <investigator>
      <last_name>Rong Tao, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Tianjin Medical Universisity Cancer Institute &amp; Hospital</name>
      <address>
        <city>Tianjin</city>
        <state>Tianjin</state>
        <zip>300060</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Suspended</status>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital, Zhejiang University School of Medicine</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310003</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Suspended</status>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>May 25, 2020</study_first_submitted>
  <study_first_submitted_qc>June 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>February 1, 2023</last_update_submitted>
  <last_update_submitted_qc>February 1, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 3, 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>Lymphoma</mesh_term>
    <mesh_term>Lymphoma, T-Cell</mesh_term>
    <mesh_term>Lymphoma, T-Cell, Peripheral</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carboplatin</mesh_term>
    <mesh_term>Gemcitabine</mesh_term>
    <mesh_term>Oxaliplatin</mesh_term>
    <mesh_term>Etoposide</mesh_term>
    <mesh_term>Ifosfamide</mesh_term>
    <mesh_term>Tislelizumab</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/NCT04425070
org study id: ATG-010-T/NK-001
nct id: NCT04425070
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This trial is proposed with treatment of ATG-010 combined with chemotherapy regimens which
      will be chosen by investigators (ICE [ifosfamide+carboplatin+etoposide] or GEMOX
      [gemcitabine+oxaliplatin] or Tislelizumab), after treatments of 2 to 6 cycles transferring to
      ATG-010 monotherapy maintenance treatment, to evaluate the safety, tolerability, and primary
      efficacy of ATG-010 in R/R PTCL and NK/T-cell lymphoma patients.
This trial is an open-label, multi-center Phase Ib clinical study that will evaluate ATG-010
      combined with chemotherapy regimen selected by investigators (ICE regimen
      ifosfamide+carboplatin+etoposide; Or GEMOX regimen: gemcitabine+oxaliplatin; Tislelizumab)
      sequential ATG 010 monotherapy maintenance, to evaluate the safety, tolerability, and primary
      efficacy in R/R PTCL and NK/T-cell lymphoma patients. 97 patients are planned to be enrolled.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: ATG-010 + ICE ATG-010 + GEMOX ATG-010 + Tislelizumab
primary purpose: Treatment
masking: None (Open Label)
measure: AEs/SAEs
time frame: 18 months
description: Toxicity will be graded according to the NCI CTCAE, Version 5.0.
measure: Overall Response Rate (ORR)
time frame: 18 months
description: To determine the overall response rate according to Chenson 2014.
measure: Duration of response (DOR)
time frame: 18 months
description: Duration of time from first occurrence of CR or PR until the first date that disease progression is objectively documented.
measure: Disease control rate (DCR)
time frame: 4 weeks to 18 months
description: Proportion of patients who achieve CR, PR, or SD for a minimum of 4 weeks, following the first dose of study drug (i.e., CR+PR+SD)
measure: Progression-free survival (PFS)
time frame: 18 months
description: Duration of time from the first dose of study drug until progression or death due to any cause
measure: Overall Survival (OS)
time frame: 18 months
description: Duration of time from the first dose of study drug until death due to any cause
arm group label: ATG-010 + ICE
arm group type: Experimental
description: ATG-010 60 mg/once,total twice in each cycle; on Days 4 and 11
arm group label: ATG-010 + GEMOX
arm group type: Experimental
description: ATG-010 60 mg/once,total twice in each cycle; on Days 2 and 9
arm group label: ATG-010 + Tislelizumab
arm group type: Experimental
description: ATG 010 40mg/once, will be given on Days 1, 8, and 15 of each cycle
intervention type: Combination Product
intervention name: ICE [ifosfamide+carboplatin+etoposide]
description: • Combined with ICE chemotherapy regimen:
Ifosfamide: 5 g/m2, continuous intravenous (iv) infusion (mesna 5 g/m2 synchronously iv infusion for rescue), on Day 2;
Carboplatin: with concentration-area under time curve (AUC)=5 (highest concentration to 800 mg), iv infusion, on Day 2;
Etoposide l00 mg/m2, iv infusion, on Days 1-3;
ATG-010 60 mg/once, oral, on Days 4 and 11. After the treatment with combination chemotherapy, the patients will continue to receive maintenance treatment of ATG-010 60 mg/once per week (QW).
arm group label: ATG-010 + ICE
intervention type: Combination Product
intervention name: GEMOX [gemcitabine+oxaliplatin]
description: • Combined with GEMOX chemotherapy regimen:
Gemcitabine 1000 mg/m2, iv infusion, on Days 1 and 8;
Oxaliplatin 130 mg/m2, iv infusion, on Day 1;
ATG-010 60 mg/once, oral, on Days 2 and 9. After the treatment with combination chemotherapy, the patients will continue to receive maintenance treatment of ATG-010 60 mg/once per week (QW).
arm group label: ATG-010 + GEMOX
intervention type: Combination Product
intervention name: Tislelizumab
description: Tislelizumab will be administered intravenously at a fixed dose of 2 0 0 mg every 3 weeks on Day 1 of each cycle
arm group label: ATG-010 + Tislelizumab
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sai Lou, MD
role: Study Director
affiliation: Medical Director
last name: Yang Yu, MD
role: Study Director
affiliation: Medical Director
last name: Sunny He, M.D.
phone: 13701803117
email: sunny.he@antengene.com
last name: Sara Wang
phone: 17601350610
email: sara.wang@antengene.com
facility: 
status: Suspended
facility: 
status: Suspended
facility: 
status: Suspended
facility: 
status: Suspended
facility: 
status: Recruiting
investigator: 
facility: 
status: Suspended
facility: 
status: Suspended
facility: 
status: Suspended
facility: 
status: Suspended
facility: 
status: Suspended
facility: 
status: Withdrawn
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Suspended
facility: 
status: Suspended
country: China
responsible party type: Sponsor
mesh term: Lymphoma
mesh term: Lymphoma, T-Cell
mesh term: Lymphoma, T-Cell, Peripheral
mesh term: Carboplatin
mesh term: Gemcitabine
mesh term: Oxaliplatin
mesh term: Etoposide
mesh term: Ifosfamide
mesh term: Tislelizumab