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/NCT06008379</url>
    </required_header>
    <id_info>
      <org_study_id>7MW3711-2023-CP102</org_study_id>
      <nct_id>NCT06008379</nct_id>
    </id_info>
    <brief_title>A Study of 7MW3711 in Subjects With Advanced Solid Tumors</brief_title>
    <official_title>A Phase 1/2 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>
      <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 a antibody-drug conjugate(ADC) drected 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 pahse 2&#xD;
        dose(RP2D) of 7MW3711 in subjects with advanced solid tumors.&#xD;
  &#xD;
        The part of cohort expansion(part 2) will enrolled subejcts with selected advanced solid&#xD;
        tumors and is to assess the preliminary efficacy of 7MW3711 in selected advanced solid&#xD;
        tumors.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 28, 2023</start_date>
    <completion_date type="Anticipated">January 30, 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>
    </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 completeresponse (CR) or partial response (PR)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>evaluation of PK parameters of 7MW3711</measure>
      <time_frame>approximately up to 2 years</time_frame>
      <description>Maximum observed concentration(Cmax)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>evaluation of PK parameters of 7MW3711</measure>
      <time_frame>approximately up to 2 years</time_frame>
      <description>the time to Cmax(tmax)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>evaluation of PK parameters of 7MW3711</measure>
      <time_frame>approximately up to 2 years</time_frame>
      <description>half-live(t1/2)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>evaluation of PK parameters of 7MW3711</measure>
      <time_frame>approximately up to 2 years</time_frame>
      <description>Area under the concentration-time curve(AUC)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>overall response rate (ORR) (part1)</measure>
      <time_frame>approximately up to 1 years</time_frame>
      <description>ORR:defined as the proportion of patients who achieved a best overall response of completeresponse (CR) or partial response (PR) based on RECIST version 1.1.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>disease control rate(DCR)</measure>
      <time_frame>approximately up to 2 years</time_frame>
      <description>DCR:defined as the proportion of subjects with CR, PR, and SD based on RECIST 1.1 criteria</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>progression-free survival(PFS)</measure>
      <time_frame>approximately up to 2 years</time_frame>
      <description>PFS:defined as time from the date of first administration to the date of first documented disease progression based on RECIST 1.1 criteria, or death due to any cause, whichever occurs first</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>time to response (TTR)</measure>
      <time_frame>approximately up to 2 years</time_frame>
      <description>TTR:defined as time from the date of first administration to the date of first documented CR or PR</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>evaluation of the immunogenicity of 7MW3711</measure>
      <time_frame>approximately up to 2 years</time_frame>
      <description>Frequency and percentage of subjects with positive anti-drug antibody after being treated by 7MW3711.</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>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">164</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;
            -  Part 1: Histologically or cytologically confirmed locally advanced or metastatic solid&#xD;
               tumor, progressive after last treatment received and who progressed on or after&#xD;
               standard therapies or intolerant to approved therapies or who lack of effient standard&#xD;
               therapies; part 2: Histologically or cytologically confirmed locally advanced or&#xD;
               metastatic selected advanced solid tumors having progressed after at least one line of&#xD;
               standard systermic therapy or intolerate standard 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>Sun Lu, Doctor</last_name>
      <phone>021-22200000*3121</phone>
      <email>shun-lu@hotmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Henan Cancer Hospital</name>
        <address>
          <city>Zhengzhou</city>
          <state>Henan</state>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Qiming Wang</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Hunan Cancer Hospital</name>
        <address>
          <city>Changsha</city>
          <state>Hunan</state>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Yongzhong Luo</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Xuzhou Central Hospital</name>
        <address>
          <city>Xuzhou</city>
          <state>Jiangsu</state>
          <zip>221009</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Liang Han</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>The Lung Cancer Center of Shanghai Chest Hospital</name>
        <address>
          <city>Shanghai</city>
          <state>Shanghai</state>
          <zip>2000043</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Sun Lu, Doctor</last_name>
        <phone>021-22200000*3121</phone>
        <email>shun-lu@hotmail.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Zhejiang Cancer Hospital</name>
        <address>
          <city>Hangzhou</city>
          <state>Zhejiang</state>
          <zip>310000</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Zhengbo Song, Doctor</last_name>
        <email>songzb@zjcc.org.cn</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>
    <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/NCT06008379
  org study id: 7MW3711-2023-CP102
  nct id: NCT06008379
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  7MW3711 is a antibody-drug conjugate(ADC) drected 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 pahse 2
        dose(RP2D) of 7MW3711 in subjects with advanced solid tumors.
  
        The part of cohort expansion(part 2) will enrolled subejcts with selected advanced solid
        tumors and is to assess the preliminary efficacy of 7MW3711 in selected 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
  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 completeresponse (CR) or partial response (PR)
  measure: evaluation of PK parameters of 7MW3711
  time frame: approximately up to 2 years
  description: Maximum observed concentration(Cmax)
  measure: evaluation of PK parameters of 7MW3711
  time frame: approximately up to 2 years
  description: the time to Cmax(tmax)
  measure: evaluation of PK parameters of 7MW3711
  time frame: approximately up to 2 years
  description: half-live(t1/2)
  measure: evaluation of PK parameters of 7MW3711
  time frame: approximately up to 2 years
  description: Area under the concentration-time curve(AUC)
  measure: overall response rate (ORR) (part1)
  time frame: approximately up to 1 years
  description: ORR:defined as the proportion of patients who achieved a best overall response of completeresponse (CR) or partial response (PR) based on RECIST version 1.1.
  measure: disease control rate(DCR)
  time frame: approximately up to 2 years
  description: DCR:defined as the proportion of subjects with CR, PR, and SD based on RECIST 1.1 criteria
  measure: progression-free survival(PFS)
  time frame: approximately up to 2 years
  description: PFS:defined as time from the date of first administration to the date of first documented disease progression based on RECIST 1.1 criteria, or death due to any cause, whichever occurs first
  measure: time to response (TTR)
  time frame: approximately up to 2 years
  description: TTR:defined as time from the date of first administration to the date of first documented CR or PR
  measure: evaluation of the immunogenicity of 7MW3711
  time frame: approximately up to 2 years
  description: Frequency and percentage of subjects with positive anti-drug antibody after being treated by 7MW3711.
  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.
  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: Sun Lu, Doctor
  phone: 021-22200000*3121
  email: shun-lu@hotmail.com
  facility: 
  status: Not yet recruiting
  contact: 
  facility: 
  status: Not yet recruiting
  contact: 
  facility: 
  status: Not yet recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Not yet recruiting
  contact: 
  country: China
  responsible party type: Sponsor
  mesh term: Neoplasms
  sharing ipd: No