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/NCT06026605</url>
    </required_header>
    <id_info>
      <org_study_id>Reboot-102</org_study_id>
      <nct_id>NCT06026605</nct_id>
    </id_info>
    <brief_title>A Dose Escalation and Dose Expansion Trial of WTX212A in the Treatment of Patients With Advanced Malignant Tumors</brief_title>
    <official_title>A MulticenterOpen LableDose Escalat Tion and Dose Expansion Clinical Study to Evaluate the Safety, Tolerance and Ini Itial Effectiveness of WTX212A Injection in Patients With Unresectable or Metasta Atic Advanced Solid Tumors</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Zhejiang University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Zhejiang University</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 trial is a multi-center, open-label investigator-initiated clinical study (IIT) to&#xD;
        evaluate the safety, pharmacokinetics, pharmacodynamics and effectiveness of WTX212A&#xD;
        injection in the treatment of patients with unresectable or metastatic advanced solid tumors&#xD;
        who failed in previous systematic therapy.&#xD;
  &#xD;
        The study was divided into two phases: dose escalation and dose expansion&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The study was divided into two phases: dose escalation and dose expansion Detailed&#xD;
        Description: This trial is a multi-center, open-label investigator-initiated clinical&#xD;
        study(llT)to evaluate the safety, pharmacokinetics, pharmacodynamics and effectiveness of&#xD;
        WTX212A injection in the treatment of patients with unresectable or metastatic advanced solid&#xD;
        tumors who failed in previous systematic therapy.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 30, 2023</start_date>
    <completion_date type="Anticipated">May 30, 2025</completion_date>
    <primary_completion_date type="Anticipated">August 30, 2024</primary_completion_date>
    <phase>Early Phase 1</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>incidence of adverse events</measure>
      <time_frame>through study completion, an average of 1 year</time_frame>
      <description>The incidence of Adverse Events during the treatment of WTX212A injection</description>
    </primary_outcome>
    <primary_outcome>
      <measure>incidence of treatment related adverse events (TRAE)</measure>
      <time_frame>through study completion, an average of 1 year</time_frame>
      <description>The incidence of TRAE during the treatment of WTX212A injection</description>
    </primary_outcome>
    <primary_outcome>
      <measure>incidence of severe adverse events (SAE)</measure>
      <time_frame>through study completion, an average of 1 year</time_frame>
      <description>The incidence of SAE during the treatment of WTX212A injection</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Cmax</measure>
      <time_frame>through study completion, an average of 1 months</time_frame>
      <description>Cmax</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Tmax</measure>
      <time_frame>through study completion, an average of 1 months</time_frame>
      <description>Tmax</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>AUC0-t</measure>
      <time_frame>through study completion, an average of 1 months</time_frame>
      <description>AUC0-t</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>t1/2</measure>
      <time_frame>through study completion, an average of 1 months</time_frame>
      <description>t1/2</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>CL</measure>
      <time_frame>through study completion, an average of 1 months</time_frame>
      <description>CL</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cmin,ss</measure>
      <time_frame>through study completion, an average of 1 months</time_frame>
      <description>Cmin,ss</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cmax,ss</measure>
      <time_frame>through study completion, an average of 1 months</time_frame>
      <description>Cmax,ss</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Tmax,ss</measure>
      <time_frame>through study completion, an average of 1 months</time_frame>
      <description>Tmax,ss</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>AUC（0-τ）ss.</measure>
      <time_frame>through study completion, an average of 1 months</time_frame>
      <description>AUC（0-τ）ss.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>the occupancy rate of PD-1 receptor on the surface of peripheral blood T cells</measure>
      <time_frame>through study completion, an average of 1 year</time_frame>
      <description>the occupancy rate of PD-1 receptor on the surface of peripheral blood T cells in subjects after WTX212A infusion</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Objecive Response Rate (ORR)</measure>
      <time_frame>through study completion, an average of 4 months</time_frame>
      <description>According to Response Evaluation Criteria In Solid Tumors Version 1.1</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Anti-drug antibody (ADA)</measure>
      <time_frame>through study completion, an average of 1 year</time_frame>
      <description>escribe the number and percentage of anti-drug antibodies (ADA) produced by subjects at each time point after treatment, and the time of producing ADA</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Anti-drug antibodies (ADA)</measure>
      <time_frame>through study completion, an average of 1 year</time_frame>
      <description>The proportion of anti-drug antibodies (ADA) after WTX212A infusion</description>
    </other_outcome>
    <other_outcome>
      <measure>The absolute value of immune cell subsets</measure>
      <time_frame>through study completion, an average of 1 year</time_frame>
      <description>The absolute value of immune cell subsets</description>
    </other_outcome>
    <other_outcome>
      <measure>The percentage of immune cell subsets</measure>
      <time_frame>through study completion, an average of 1 year</time_frame>
      <description>The percentage of immune cell subsets</description>
    </other_outcome>
    <other_outcome>
      <measure>The proportion of PD-L1 expression in tumor cells/immune cells</measure>
      <time_frame>through study completion, an average of 1 year</time_frame>
      <description>The proportion of PD-L1 expression in tumor cells/immune cells</description>
    </other_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">44</enrollment>
    <condition>Unresectable or Metastatic Advanced Solid Tumors</condition>
    <arm_group>
      <arm_group_label>WTX212A</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>WTX212A infusion once every 21 days</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>WTX212A</intervention_name>
      <description>WTX212A infusion once every 21 days</description>
      <arm_group_label>WTX212A</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  1. Must signs an informed consent form, understands this study, is willing to follow&#xD;
               and has the ability to complete all experimental procedures; 2. Aged 18 to 75 years&#xD;
               old (including threshold); 3. Histopathology diagnosed unresectable or metastatic&#xD;
               solid tumors who have failed systemic treatment or have no effective standard&#xD;
               treatment, or who are unwilling to accept standard treatment or are not suitable for&#xD;
               standard treatment; 4. ECOG≤1； 5. Expected life ≥ 3 months； 6. Male participants,&#xD;
               their spouses, and female participants of childbearing age should agree to use a&#xD;
               medically recognized effective contraceptive method from the signing of the informed&#xD;
               consent form until 3 months after the last administration; 7. Women of childbearing&#xD;
               age must have a negative pregnancy testing results within ≤ 7 days before the first&#xD;
               trial drug administration.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          - 1. Other serious medical diseases, including but not limited to: uncontrolled diabetes,&#xD;
          active peptic ulcer, active bleeding, etc., and people with uncontrollable or serious&#xD;
          cardiovascular diseases, 2. Pleural and ascitic fluids with clinical symptoms and the need&#xD;
          for repeated drainage; 3. Previous or recent history of pulmonary fibrosis, severe lung&#xD;
          function damage caused by pneumoconiosis, radiation pneumonia, and drug-related pneumonia;&#xD;
          4. History of adverse events related to the use of IO drugs that require permanent&#xD;
          cessation of IO treatment; 5. Known to have other malignant tumors, currently progressing&#xD;
          or completing treatment at least once in the past 3 years.&#xD;
  &#xD;
          6. Symptomatic central nervous system (CNS) metastasis confirmed by imaging or pathological&#xD;
          examination and clinically unstable for at least 14 days prior to enrollment who require&#xD;
          steroid treatment; 7. Hereditary bleeding tendencies or coagulation disorders, or a history&#xD;
          of thrombosis, hemolysis, or hemorrhagic diseases; 8. Received significant surgical&#xD;
          treatment or obvious traumatic injury within 28 days prior to the start of research&#xD;
          treatment;&#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>Qi Zhang, M.D.</last_name>
      <phone>13858108798</phone>
      <email>qi.zhang@zju.edu.cn</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Qihan Fu, M.D.</last_name>
      <email>ayfuqihan@126.com</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 21, 2023</study_first_submitted>
    <study_first_submitted_qc>September 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 7, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Zhejiang University</investigator_affiliation>
      <investigator_full_name>TingBo Liang</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT06026605
  org study id: Reboot-102
  nct id: NCT06026605
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This trial is a multi-center, open-label investigator-initiated clinical study (IIT) to
        evaluate the safety, pharmacokinetics, pharmacodynamics and effectiveness of WTX212A
        injection in the treatment of patients with unresectable or metastatic advanced solid tumors
        who failed in previous systematic therapy.
  
        The study was divided into two phases: dose escalation and dose expansion
  The study was divided into two phases: dose escalation and dose expansion Detailed
        Description: This trial is a multi-center, open-label investigator-initiated clinical
        study(llT)to evaluate the safety, pharmacokinetics, pharmacodynamics and effectiveness of
        WTX212A injection in the treatment of patients with unresectable or metastatic advanced solid
        tumors who failed in previous systematic therapy.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: incidence of adverse events
  time frame: through study completion, an average of 1 year
  description: The incidence of Adverse Events during the treatment of WTX212A injection
  measure: incidence of treatment related adverse events (TRAE)
  time frame: through study completion, an average of 1 year
  description: The incidence of TRAE during the treatment of WTX212A injection
  measure: incidence of severe adverse events (SAE)
  time frame: through study completion, an average of 1 year
  description: The incidence of SAE during the treatment of WTX212A injection
  measure: Cmax
  time frame: through study completion, an average of 1 months
  description: Cmax
  measure: Tmax
  time frame: through study completion, an average of 1 months
  description: Tmax
  measure: AUC0-t
  time frame: through study completion, an average of 1 months
  description: AUC0-t
  measure: t1/2
  time frame: through study completion, an average of 1 months
  description: t1/2
  measure: CL
  time frame: through study completion, an average of 1 months
  description: CL
  measure: Cmin,ss
  time frame: through study completion, an average of 1 months
  description: Cmin,ss
  measure: Cmax,ss
  time frame: through study completion, an average of 1 months
  description: Cmax,ss
  measure: Tmax,ss
  time frame: through study completion, an average of 1 months
  description: Tmax,ss
  measure: AUC（0-τ）ss.
  time frame: through study completion, an average of 1 months
  description: AUC（0-τ）ss.
  measure: the occupancy rate of PD-1 receptor on the surface of peripheral blood T cells
  time frame: through study completion, an average of 1 year
  description: the occupancy rate of PD-1 receptor on the surface of peripheral blood T cells in subjects after WTX212A infusion
  measure: Objecive Response Rate (ORR)
  time frame: through study completion, an average of 4 months
  description: According to Response Evaluation Criteria In Solid Tumors Version 1.1
  measure: Anti-drug antibody (ADA)
  time frame: through study completion, an average of 1 year
  description: escribe the number and percentage of anti-drug antibodies (ADA) produced by subjects at each time point after treatment, and the time of producing ADA
  measure: Anti-drug antibodies (ADA)
  time frame: through study completion, an average of 1 year
  description: The proportion of anti-drug antibodies (ADA) after WTX212A infusion
  measure: The absolute value of immune cell subsets
  time frame: through study completion, an average of 1 year
  description: The absolute value of immune cell subsets
  measure: The percentage of immune cell subsets
  time frame: through study completion, an average of 1 year
  description: The percentage of immune cell subsets
  measure: The proportion of PD-L1 expression in tumor cells/immune cells
  time frame: through study completion, an average of 1 year
  description: The proportion of PD-L1 expression in tumor cells/immune cells
  arm group label: WTX212A
  arm group type: Experimental
  description: WTX212A infusion once every 21 days
  intervention type: Drug
  intervention name: WTX212A
  description: WTX212A infusion once every 21 days
  arm group label: WTX212A
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Qi Zhang, M.D.
  phone: 13858108798
  email: qi.zhang@zju.edu.cn
  last name: Qihan Fu, M.D.
  email: ayfuqihan@126.com
  responsible party type: Principal Investigator
  investigator affiliation: Zhejiang University
  investigator full name: TingBo Liang
  investigator title: Professor
  sharing ipd: No