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/NCT05978401</url>
    </required_header>
    <id_info>
      <org_study_id>GLS-012-21</org_study_id>
      <nct_id>NCT05978401</nct_id>
    </id_info>
    <brief_title>Safety, Tolerability, and Efficacy of GLS-012 and GLS-010 in Patients With Advanced Non-Small Cell Lung Cancer</brief_title>
    <official_title>A Phase I/II Study Evaluating the Safety, Tolerability, and Efficacy of GLS-012 and GLS-010 in Patients With Advanced Non-Small Cell Lung Cancer (Triumph-02)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Guangzhou Gloria Biosciences Co., Ltd.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Guangzhou Gloria Biosciences Co., Ltd.</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 is a multicenter, open Phase I/II study. The trial consists of two parts, Part1 is a&#xD;
        dose-escalation/expansion study, Part2 is a combination of GLS-010 and GLS-010+GLS-012 with&#xD;
        standard chemotherapy for advanced non-small-cell lung cancer respectively to assess&#xD;
        preliminary efficacy at the combination dose.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 10, 2023</start_date>
    <completion_date type="Anticipated">April 1, 2026</completion_date>
    <primary_completion_date type="Anticipated">April 1, 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>Non-Randomized</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <intervention_model_description>Part1 section is a dose-escalation/expansion study in a single-arm setup； Part2 section sets up a control.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
      <masking_description>Part1 section is a dose-escalation/expansion study in a single-arm setup； Part2 section sets up a control； All processes do not involve blind settings.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>DLT/MTD</measure>
      <time_frame>24 months</time_frame>
      <description>To evaluate GLS-012 in combination with GLS-010 dose-limiting toxicity (DLT)/maximum tolerated dose (MTD) in patients with advanced non-small cell lung cancer</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Investigator Assessments of Overall Response Rate(ORR)</measure>
      <time_frame>24 months</time_frame>
      <description>RECIST v1.1 will be used to determine ORR by investigator</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>PFS (progression-free survival)</measure>
      <time_frame>24 months</time_frame>
      <description>RECIST v1.1 will be used to determine PFS by investigator</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Disease Control Rate(DCR)</measure>
      <time_frame>24 months</time_frame>
      <description>RECIST v1.1 will be used to determine DCR by investigator</description>
    </secondary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">152</enrollment>
    <condition>Advanced Non-Small Cell Lung Cancer</condition>
    <arm_group>
      <arm_group_label>Phase I Dose-Escalation Stage：GLS-012+GLS-010</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will be treated with escalating doses of GLS-010 + GLS-012 to determine the MTD</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Phase I Expansion Stage：GLS-012+GLS-010</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will be enrolled in the expansion stage to better characterize the safety, tolerability, PK variability, and preliminary efficacy of GLS-012+GLS-010 in Advanced Non-Small Cell Lung Cancer.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>GLS-012+GLS-010+pemetrexed + carboplatin</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will be enrolled in the expansion stage to better characterize the safety, PK variability, and preliminary efficacy of GLS-012+GLS-010+pemetrexed+carboplatin in Advanced Non-Small Cell Lung Cancer.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>GLS-012+GLS-010+paclitaxel+carboplatin</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will be enrolled in the expansion stage to better characterize the safety, PK variability, and preliminary efficacy of GLS-012+GLS-010+paclitaxel+carboplatin in Advanced Non-Small Cell Lung Cancer.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>GLS-012+GLS-010</intervention_name>
      <description>Two dose levels will be evaluated for GLS-012+GLS-010 administered. GLS-012+GLS-010 will be given via intravenous (IV) infusion on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit.</description>
      <arm_group_label>Phase I Dose-Escalation Stage：GLS-012+GLS-010</arm_group_label>
      <other_name>LAG3</other_name>
      <other_name>PD-1</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>GLS-012+GLS-010</intervention_name>
      <description>Target dose levels will be evaluated for GLS-012+GLS-010 administered. GLS-012+GLS-010 will be given via intravenous (IV) infusion on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit.</description>
      <arm_group_label>Phase I Expansion Stage：GLS-012+GLS-010</arm_group_label>
      <other_name>LAG3</other_name>
      <other_name>PD-1</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>GLS-012+GLS-010+pemetrexed+carboplatin</intervention_name>
      <description>GLS-012+GLS-010 will be given via IV infusion on Day 1 of each 21-day cycle in combination with pemetrexed and carboplatin. Combination treatment will be administered 4~6 cycles.GLS-012+GLS-010/GLS-010 may continue until disease progression or loss of clinical benefit.</description>
      <arm_group_label>GLS-012+GLS-010+pemetrexed + carboplatin</arm_group_label>
      <other_name>LAG3</other_name>
      <other_name>PD-1</other_name>
      <other_name>chemotherapy</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>GLS-012+GLS-010+paclitaxel+carboplatin</intervention_name>
      <description>GLS-012+GLS-010 will be given via IV infusion on Day 1 of each 21-day cycle in combination with paclitaxel and carboplatin. Combination treatment will be administered 4~6 cycles.GLS-012+GLS-010/GLS-010 may continue until disease progression or loss of clinical benefit.</description>
      <arm_group_label>GLS-012+GLS-010+paclitaxel+carboplatin</arm_group_label>
      <other_name>LAG3</other_name>
      <other_name>PD-1</other_name>
      <other_name>chemotherapy</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Subjects enroll in the study and sign the Informed Consent Form (ICF);&#xD;
  &#xD;
            2. Aged ≥18 years and ≤75 years;&#xD;
  &#xD;
            3. histologically or cytologically confirmed advanced non-small cell lung cancer without&#xD;
               driver genes (diagnostic criteria refer to AJCC 8th edition of squamous or&#xD;
               non-squamous non-small cell lung cancer);&#xD;
  &#xD;
            4. Subjects with an Eastern Cooperative Oncology Group (ECOG) score of 0 ~1 for physical&#xD;
               status;&#xD;
  &#xD;
            5. expected survival ≥ 12 weeks;&#xD;
  &#xD;
            6. Subjects with measurable lesions (at least 1 extracranial lesion) according to the&#xD;
               Solid Tumor Evaluation Criteria (RECIST v1.1).&#xD;
  &#xD;
            7. Subjects provide formalin-fixed, paraffin-embedded tumor tissue blocks or unstained&#xD;
               tumor specimen sections (at least 6), either archived or freshly obtained within 5&#xD;
               years prior to the first study treatment (freshly obtained is preferred);&#xD;
  &#xD;
            8. Organ function meets the following criteria:&#xD;
  &#xD;
                 1. Adequate bone marrow reserve (not acceptable for corrective therapy with&#xD;
                    hematologic products or cell growth factors administered within 14 days prior to&#xD;
                    first study dose): absolute neutrophil count ≥ 1.5 x 109/L, platelet count ≥ 90 x&#xD;
                    109/L, and hemoglobin ≥ 9 g/dL;&#xD;
  &#xD;
                 2. Liver: serum albumin ≥ 3.0 g/dL; total bilirubin ≤ 1.5 times the Upper Limit of&#xD;
                    Normal (ULN), and ALT and AST ≤ 3 times the ULN (or AST and ALT ≤ 5 × ULN for&#xD;
                    patients with known liver metastases);&#xD;
  &#xD;
                 3. Renal: blood creatinine ≤ 1.25 times ULN;&#xD;
  &#xD;
                 4. Heart: left ventricular ejection fraction (LVEF) ≥ 50%.&#xD;
  &#xD;
            9. Subjects of childbearing potential must be using highly effective contraception during&#xD;
               the study and for at least 6 months after the last dose; female subjects of&#xD;
               childbearing potential must have a negative blood pregnancy test within 3 days prior&#xD;
               to study enrollment.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Severe immunotherapy-related toxicity during prior treatment with anti-ICIs;&#xD;
  &#xD;
            2. Prior grade ≥ 3 irAE on immunotherapy and who have not recovered to grade ≤ 1 from the&#xD;
               last adverse reaction to antineoplastic therapy;&#xD;
  &#xD;
            3. With primary or secondary immunodeficiency；&#xD;
  &#xD;
            4. Any active, known or suspected autoimmune disease;&#xD;
  &#xD;
            5. Known CNS metastases ;&#xD;
  &#xD;
            6. Prior severe allergic reactions to large protein preparations/monoclonal antibodies&#xD;
               (CTCAE V5.0 classification ≥ grade 4);&#xD;
  &#xD;
            7. Previous treatment with anti-LAG-3 antibodies;&#xD;
  &#xD;
            8. Other malignant tumors within 5 years prior to screening, except cured cervical&#xD;
               carcinoma in situ and cured basal cell carcinoma of the skin;&#xD;
  &#xD;
            9. Have uncontrolled cardiac clinical symptoms or disease；&#xD;
  &#xD;
           10. Subjects have received a live attenuated vaccine (except inactivated viral seasonal&#xD;
               influenza vaccine and novel coronavirus vaccine) within 4 weeks prior to the first&#xD;
               dose and who will not receive intranasally administered live attenuated influenza&#xD;
               vaccine;&#xD;
  &#xD;
           11. Pregnant or nursing females；&#xD;
  &#xD;
           12. Poorly compliant or otherwise unsuitable for participation in this study.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Shang Hai Pulmonary Hospital</name>
        <address>
          <city>Shanghai</city>
          <state>Shanghai</state>
          <zip>200433</zip>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Caicun Zhou</last_name>
        <phone>021-65115006</phone>
        <email>caicunzhoudr@163.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 26, 2023</study_first_submitted>
    <study_first_submitted_qc>August 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>August 3, 2023</last_update_submitted>
    <last_update_submitted_qc>August 3, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 7, 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>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>Paclitaxel</mesh_term>
      <mesh_term>Carboplatin</mesh_term>
      <mesh_term>Pemetrexed</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/NCT05978401
  org study id: GLS-012-21
  nct id: NCT05978401
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This is a multicenter, open Phase I/II study. The trial consists of two parts, Part1 is a
        dose-escalation/expansion study, Part2 is a combination of GLS-010 and GLS-010+GLS-012 with
        standard chemotherapy for advanced non-small-cell lung cancer respectively to assess
        preliminary efficacy at the combination dose.
  allocation: Non-Randomized
  intervention model: Single Group Assignment
  intervention model description: Part1 section is a dose-escalation/expansion study in a single-arm setup； Part2 section sets up a control.
  primary purpose: Treatment
  masking: None (Open Label)
  masking description: Part1 section is a dose-escalation/expansion study in a single-arm setup； Part2 section sets up a control； All processes do not involve blind settings.
  measure: DLT/MTD
  time frame: 24 months
  description: To evaluate GLS-012 in combination with GLS-010 dose-limiting toxicity (DLT)/maximum tolerated dose (MTD) in patients with advanced non-small cell lung cancer
  measure: Investigator Assessments of Overall Response Rate(ORR)
  time frame: 24 months
  description: RECIST v1.1 will be used to determine ORR by investigator
  measure: PFS (progression-free survival)
  time frame: 24 months
  description: RECIST v1.1 will be used to determine PFS by investigator
  measure: Disease Control Rate(DCR)
  time frame: 24 months
  description: RECIST v1.1 will be used to determine DCR by investigator
  arm group label: Phase I Dose-Escalation Stage：GLS-012+GLS-010
  arm group type: Experimental
  description: Participants will be treated with escalating doses of GLS-010 + GLS-012 to determine the MTD
  arm group label: Phase I Expansion Stage：GLS-012+GLS-010
  arm group type: Experimental
  description: Participants will be enrolled in the expansion stage to better characterize the safety, tolerability, PK variability, and preliminary efficacy of GLS-012+GLS-010 in Advanced Non-Small Cell Lung Cancer.
  arm group label: GLS-012+GLS-010+pemetrexed + carboplatin
  arm group type: Experimental
  description: Participants will be enrolled in the expansion stage to better characterize the safety, PK variability, and preliminary efficacy of GLS-012+GLS-010+pemetrexed+carboplatin in Advanced Non-Small Cell Lung Cancer.
  arm group label: GLS-012+GLS-010+paclitaxel+carboplatin
  arm group type: Experimental
  description: Participants will be enrolled in the expansion stage to better characterize the safety, PK variability, and preliminary efficacy of GLS-012+GLS-010+paclitaxel+carboplatin in Advanced Non-Small Cell Lung Cancer.
  intervention type: Drug
  intervention name: GLS-012+GLS-010
  description: Two dose levels will be evaluated for GLS-012+GLS-010 administered. GLS-012+GLS-010 will be given via intravenous (IV) infusion on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit.
  arm group label: Phase I Dose-Escalation Stage：GLS-012+GLS-010
  other name: LAG3
  other name: PD-1
  intervention type: Drug
  intervention name: GLS-012+GLS-010
  description: Target dose levels will be evaluated for GLS-012+GLS-010 administered. GLS-012+GLS-010 will be given via intravenous (IV) infusion on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit.
  arm group label: Phase I Expansion Stage：GLS-012+GLS-010
  other name: LAG3
  other name: PD-1
  intervention type: Drug
  intervention name: GLS-012+GLS-010+pemetrexed+carboplatin
  description: GLS-012+GLS-010 will be given via IV infusion on Day 1 of each 21-day cycle in combination with pemetrexed and carboplatin. Combination treatment will be administered 4~6 cycles.GLS-012+GLS-010/GLS-010 may continue until disease progression or loss of clinical benefit.
  arm group label: GLS-012+GLS-010+pemetrexed + carboplatin
  other name: LAG3
  other name: PD-1
  other name: chemotherapy
  intervention type: Drug
  intervention name: GLS-012+GLS-010+paclitaxel+carboplatin
  description: GLS-012+GLS-010 will be given via IV infusion on Day 1 of each 21-day cycle in combination with paclitaxel and carboplatin. Combination treatment will be administered 4~6 cycles.GLS-012+GLS-010/GLS-010 may continue until disease progression or loss of clinical benefit.
  arm group label: GLS-012+GLS-010+paclitaxel+carboplatin
  other name: LAG3
  other name: PD-1
  other name: chemotherapy
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  facility: 
  contact: 
  country: China
  responsible party type: Sponsor
  mesh term: Lung Neoplasms
  mesh term: Carcinoma, Non-Small-Cell Lung
  mesh term: Paclitaxel
  mesh term: Carboplatin
  mesh term: Pemetrexed