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/NCT06008366</url>
    </required_header>
    <id_info>
      <org_study_id>7MW3711-2023-CP101</org_study_id>
      <nct_id>NCT06008366</nct_id>
    </id_info>
    <brief_title>A Phase 1/2 Study of 7MW3711 in Advanced Solid Tumors</brief_title>
    <official_title>A Phase Ⅰ/Ⅱ Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of 7MW3711 in Subjects With Advanced Solid Tumors</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Mabwell (Shanghai) Bioscience Co., Ltd.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Mabwell (Shanghai) Bioscience 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>
        7MW3711 is an antibody-drug conjugate(ADC) directed to a target wildly expressed on solid&#xD;
        tumors. This is an open-label, multicenter, phase 1/2 study to evaluate the Safety,&#xD;
        Tolerability, Pharmacokinetics, and Efficacy of 7MW3711 in subjects with advanced solid&#xD;
        tumors.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Two parts are included in this study. The part of dose escalation and dose expansion(part 1)&#xD;
        will enrolled subjects with advanced solid tumors and is to evaluate the safety and&#xD;
        tolerability and to determine the maximum tolerated dose and/or the recommend phase 2&#xD;
        dose(RP2D) of 7MW3711 in subjects with advanced solid tumors.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">September 5, 2023</start_date>
    <completion_date type="Anticipated">February 1, 2026</completion_date>
    <primary_completion_date type="Anticipated">August 30, 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>Sequential Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>evaluation of the incidence of adverse events (AEs) (part 1)</measure>
      <time_frame>approximately up to 16 cycles, 21 days a cycle</time_frame>
      <description>Incidence and seriousness of adverse events (AEs) and serious adverse events (SAEs) by CTCAE version 5.0</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Identification of the MTD and /or RP2D of 7MW3711(part 1)</measure>
      <time_frame>from Day1 to Day21 in cycle1 of part 1</time_frame>
      <description>MTD(maximum tolerated dose) and /or RP2D(recommended phase II dose)of 7MW3711(part 1)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Overall response rate (ORR) evaluated by investigators based on RECIST version 1.1 in selected solid tumors(part 2)</measure>
      <time_frame>approximately up to 2 years</time_frame>
      <description>ORR:defined as the proportion of patients who achieved a best overall response of complete response (CR) or partial response (PR)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>overall response rate (ORR) (part1)</measure>
      <time_frame>approximately up to 1 year</time_frame>
      <description>ORR:defined as the proportion of patients who achieved a best overall response of complete response (CR) or partial response (PR) based on RECIST version 1.1</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>evaluation of the incidence of adverse events (AEs) (part 2)</measure>
      <time_frame>approximately up to 2 years</time_frame>
      <description>Incidence and seriousness of adverse events (AEs) and serious adverse events (SAEs) by CTCAE version 5.0</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>evaluation of Peak Plasma Concentration (Cmax) of 7MW3711</measure>
      <time_frame>approximately up to 2 years</time_frame>
      <description>Peak Plasma Concentration（Cmax）</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>evaluation of AUC of 7MW3711</measure>
      <time_frame>approximately up to 2 years</time_frame>
      <description>Area under the plasma concentration versus time curve (AUC)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>evaluation of t1/2 of 7MW3711</measure>
      <time_frame>approximately up to 2 years</time_frame>
      <description>Half life time（t1/2）</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">281</enrollment>
    <condition>Advanced Solid Tumor</condition>
    <arm_group>
      <arm_group_label>Dose escalation and dose expansion</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>All subjects enrolled in the part of dose escalation and dose expansion will receive 7MW3711 by introvenous infusion</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Cohort expansion</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>All subjects enrolled in the part of cohort expansion will be treated by 7MW3711 will receive 7MW3711 by introvenous infusion</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>7MW3711 for injection</intervention_name>
      <description>IV administration of 7MW3711, Q3W, 3 weeks a cycle</description>
      <arm_group_label>Dose escalation and dose expansion</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>7MW3711 for injection</intervention_name>
      <description>IV administration of 7MW3711, the dosage regimen including dosage and dosing frequency for cohort expansion is conformed on basis of the data in part 1</description>
      <arm_group_label>Cohort expansion</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.&#xD;
  &#xD;
            -  Life expectancy of at least 3 months as assessed by the Investigator.&#xD;
  &#xD;
            -  Histologically or cytologically confirmed locally advanced or metastatic solid tumor,&#xD;
               progressive after last treatment received and who progressed on or after standard&#xD;
               therapies or intolerant to approved therapies or who lack of effient standard&#xD;
               therapies.&#xD;
  &#xD;
            -  An archival tumor tissue sample(formalin-fixed paraffin-embedded (FFPE) tumor tissue&#xD;
               block or at least 5 unstained slides) or a fresh tissue sample should be provided. If&#xD;
               the tissue sample cannot be provided during dose escalation, enrollment into the study&#xD;
               is allowed after discussion with the Investigator&#xD;
  &#xD;
            -  Measurable or evaluable disease by RECIST v1.1.&#xD;
  &#xD;
            -  Have adequate hematopoietic, renal and hepatic functions.&#xD;
  &#xD;
            -  Men or women willing to use adequate contraceptive measures throughout the study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Have other prior malignancies within 3 years before the first administration.&#xD;
  &#xD;
            -  Known central nervous system metastatic disease or carcinomatous meningitis except for&#xD;
               treated and stable brain metastases.&#xD;
  &#xD;
            -  Have significant, uncontrolled, or active cardiovascular disease.&#xD;
  &#xD;
            -  Known history of COPD, or intestinal lung disease, or other respiratory diseases&#xD;
               requring inpatient treatments within 4 weeks prior to first administration.&#xD;
  &#xD;
            -  Have adverse events due to prior antitumor therapy not resolved to grade 1 or lower by&#xD;
               NCI CTCAE V5.0.&#xD;
  &#xD;
            -  Have active infections requiring treatment within 14 weeks; have infection of HIV,&#xD;
               active infection of HCV and HBV.&#xD;
  &#xD;
            -  Prior treatment with an antibody drug conjugate (ADC) that consists of an&#xD;
               topoisomerase I inhibitor.&#xD;
  &#xD;
            -  Prior treatment with B7-H3 targeted agents.&#xD;
  &#xD;
            -  Have received chemotherapy, immunotherapy, curative radiation within 3 weeks prior to&#xD;
               the first administration or targeted molecular within 2 weeks prior to first&#xD;
               administration. have received Chinese patent medicine or Chinese herbs of anti-tumor&#xD;
               indications within 1 weeks prior to the first administration.&#xD;
  &#xD;
            -  Have received any systemic immunosuppressants within 2 weeks prior to the first&#xD;
               administration except for topical corticosteroids.&#xD;
  &#xD;
            -  Have received any other investigational drugs or medical device within 4 weeks prior&#xD;
               to the first administration.&#xD;
  &#xD;
            -  History of drug abuse including narcotic and psychiatric drugs within 12 months prior&#xD;
               to screening.&#xD;
  &#xD;
            -  Pregnant, or nursing females.&#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>Jian Zhang, Ph.D</last_name>
      <phone>18017312991</phone>
      <email>syner2000@163.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Ethics Committee of Fudan University Shanghai Cancer Center</name>
        <address>
          <city>Shanghai</city>
          <state>上海市</state>
          <zip>200032</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>剑 张, Doctor</last_name>
        <phone>18017312991</phone>
        <email>syner2000@163.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 7, 2023</study_first_submitted>
    <study_first_submitted_qc>August 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>September 11, 2023</last_update_submitted>
    <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 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>
    <!-- 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/NCT06008366
  org study id: 7MW3711-2023-CP101
  nct id: NCT06008366
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  7MW3711 is an antibody-drug conjugate(ADC) directed to a target wildly expressed on solid
        tumors. This is an open-label, multicenter, phase 1/2 study to evaluate the Safety,
        Tolerability, Pharmacokinetics, and Efficacy of 7MW3711 in subjects with advanced solid
        tumors.
  Two parts are included in this study. The part of dose escalation and dose expansion(part 1)
        will enrolled subjects with advanced solid tumors and is to evaluate the safety and
        tolerability and to determine the maximum tolerated dose and/or the recommend phase 2
        dose(RP2D) of 7MW3711 in subjects with advanced solid tumors.
  allocation: Non-Randomized
  intervention model: Sequential Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: evaluation of the incidence of adverse events (AEs) (part 1)
  time frame: approximately up to 16 cycles, 21 days a cycle
  description: Incidence and seriousness of adverse events (AEs) and serious adverse events (SAEs) by CTCAE version 5.0
  measure: Identification of the MTD and /or RP2D of 7MW3711(part 1)
  time frame: from Day1 to Day21 in cycle1 of part 1
  description: MTD(maximum tolerated dose) and /or RP2D(recommended phase II dose)of 7MW3711(part 1)
  measure: Overall response rate (ORR) evaluated by investigators based on RECIST version 1.1 in selected solid tumors(part 2)
  time frame: approximately up to 2 years
  description: ORR:defined as the proportion of patients who achieved a best overall response of complete response (CR) or partial response (PR)
  measure: overall response rate (ORR) (part1)
  time frame: approximately up to 1 year
  description: ORR:defined as the proportion of patients who achieved a best overall response of complete response (CR) or partial response (PR) based on RECIST version 1.1
  measure: evaluation of the incidence of adverse events (AEs) (part 2)
  time frame: approximately up to 2 years
  description: Incidence and seriousness of adverse events (AEs) and serious adverse events (SAEs) by CTCAE version 5.0
  measure: evaluation of Peak Plasma Concentration (Cmax) of 7MW3711
  time frame: approximately up to 2 years
  description: Peak Plasma Concentration（Cmax）
  measure: evaluation of AUC of 7MW3711
  time frame: approximately up to 2 years
  description: Area under the plasma concentration versus time curve (AUC)
  measure: evaluation of t1/2 of 7MW3711
  time frame: approximately up to 2 years
  description: Half life time（t1/2）
  arm group label: Dose escalation and dose expansion
  arm group type: Experimental
  description: All subjects enrolled in the part of dose escalation and dose expansion will receive 7MW3711 by introvenous infusion
  arm group label: Cohort expansion
  arm group type: Experimental
  description: All subjects enrolled in the part of cohort expansion will be treated by 7MW3711 will receive 7MW3711 by introvenous infusion
  intervention type: Drug
  intervention name: 7MW3711 for injection
  description: IV administration of 7MW3711, Q3W, 3 weeks a cycle
  arm group label: Dose escalation and dose expansion
  intervention type: Drug
  intervention name: 7MW3711 for injection
  description: IV administration of 7MW3711, the dosage regimen including dosage and dosing frequency for cohort expansion is conformed on basis of the data in part 1
  arm group label: Cohort expansion
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Jian Zhang, Ph.D
  phone: 18017312991
  email: syner2000@163.com
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Sponsor
  mesh term: Neoplasms