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/NCT05990452</url>
    </required_header>
    <id_info>
      <org_study_id>9MW2921-2023-CP101</org_study_id>
      <nct_id>NCT05990452</nct_id>
    </id_info>
    <brief_title>Phase I/II FIH Study of 9MW2921 in Patients With Advanced Solid Tumors</brief_title>
    <official_title>A Phase I/II First-in-human Study of 9MW2921 to Evaluate the Safety, Tolerability and Preliminary Efficacy of 9MW2921 in Patients 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>
        This is an open-label, Phase I-II, first-in-human (FIH) study of 9MW2921 in patients with&#xD;
        locally advanced or metastatic solid tumors refractory to all standard therapies. The&#xD;
        objective of this study is to evaluate the safety, tolerability, PK, immunogenicity and&#xD;
        Preliminary Antitumor Activity of 9MW2921.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 28, 2023</start_date>
    <completion_date type="Anticipated">December 30, 2026</completion_date>
    <primary_completion_date type="Anticipated">September 1, 2026</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>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>Dose Limited Toxicity (DLT)</measure>
      <time_frame>21 Days (first cycle)</time_frame>
      <description>To determine the dose limiting toxicities (DLTs) of 9MW2921</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Adverse Events and Serious Adverse Events</measure>
      <time_frame>up to 2 years or intolerable toxicity, disease progression or death, patient withdrawal of informed consent, withdrawal from the study and so on</time_frame>
      <description>Percentage of patients with adverse events (AEs) and serious adverse events (SAEs)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>ORR</measure>
      <time_frame>up to 2 years or intolerable toxicity, disease progression or death, patient withdrawal of informed consent, withdrawal from the study and so on</time_frame>
      <description>Defined as the percentage of subjects who experience a best response of either CR or PR.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>PK Parameters: Cmax</measure>
      <time_frame>1 years</time_frame>
      <description>Maximum concentration(Cmax)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>PK Parameters: AUC</measure>
      <time_frame>1 years</time_frame>
      <description>The area under the curve (AUC)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>PK Parameters: t1/2</measure>
      <time_frame>1 years</time_frame>
      <description>The half life(t1/2)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of ADAs Against 9MW2921</measure>
      <time_frame>up to 2 years</time_frame>
      <description>The incidence of ADAs against 9MW2921 during the study will be summarized</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Progression free survival(PFS) according to RECIST 1.1</measure>
      <time_frame>up to 2 years or intolerable toxicity, disease progression or death, patient withdrawal of informed consent, withdrawal from the study and so on</time_frame>
      <description>Time from the date of first infusion to the earliest date of documented disease progression per radiological evidence or death from any cause</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Duration of Response (DoR) according to RECIST 1.1</measure>
      <time_frame>up to 2 years or intolerable toxicity, disease progression or death, patient withdrawal of informed consent, withdrawal from the study and so on</time_frame>
      <description>Time from the date of the first complete response (CR) or partial response (PR) to the earliest date of disease progression or death from any cause. DOR is only defined for subjects who have best overall response of CR or PR.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Disease Control Rate (DCR) according to RECIST 1.1</measure>
      <time_frame>up to 2 years or intolerable toxicity, disease progression or death, patient withdrawal of informed consent, withdrawal from the study and so on</time_frame>
      <description>Defined as the percentage of subjects who experience a best response of CR, PR or stable disease (SD).</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">261</enrollment>
    <condition>Advanced Solid Tumor</condition>
    <arm_group>
      <arm_group_label>9MW2921</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>9MW2921</intervention_name>
      <description>All subjects will receive 9MW2921 by intravenous (IV) every 3 weeks.</description>
      <arm_group_label>9MW2921</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Age ≥ 18 and ≤ 75 years old, male or female, voluntarily agree to participate in the&#xD;
               study and sign the Informed Consent Form (ICF).&#xD;
  &#xD;
            2. ECOG PS is 0 or 1.&#xD;
  &#xD;
            3. Subjects must have histologically confirmed advanced and/or metastatic malignancies&#xD;
               for which failure of standard treatment or lack/intolerant of effective standard&#xD;
               treatment.&#xD;
  &#xD;
            4. Subjects must be able to provide fresh or ≥5 slides of unstained tumor tissue.&#xD;
  &#xD;
            5. Survival expectation of at least 3 months.&#xD;
  &#xD;
            6. At least one measurable lesion according to RECIST v1.1.&#xD;
  &#xD;
            7. The organ function level must meet the protocol requirements.&#xD;
  &#xD;
            8. Women and men of reproductive age must agree to use effective contraception from the&#xD;
               date of signing the informed consent until 6 months after the last administration of&#xD;
               9MW2921, and women of reproductive age must have negative serum pregnancy test results&#xD;
               within 7 days prior to administration.&#xD;
  &#xD;
            9. Ability and willingness to understand visits, treatment, laboratory tests and other&#xD;
               study procedures.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. History of other malignancy within 3 years.&#xD;
  &#xD;
            2. Subjects with active central nervous system (CNS) metastasis or meningeal metastasis.&#xD;
  &#xD;
            3. History of treatment with topoisomerase I inhibitors.&#xD;
  &#xD;
            4. Anti-tumor therapy such as traditional Chinese medicine or immunomodulatory drugs&#xD;
               within 14 days prior to the first dose of study drug, or radiotherapy, chemotherapy,&#xD;
               biological agents, immunotherapy within the previous 21 days.&#xD;
  &#xD;
            5. Adverse reactions related to previous treatments failed to recover to CTCAE 5.0 ≤1.&#xD;
  &#xD;
            6. Had major surgery within 28 days before dosing, or has surgery plan during the study&#xD;
               time (including the screening time).&#xD;
  &#xD;
            7. Subjects with clinically significant cardiovascular disease within 6 months prior to&#xD;
               the first dose of study drug.&#xD;
  &#xD;
            8. Any other serious or uncontrolled disease that, in the opinion of the investigator,&#xD;
               would make it inappropriate to participate in the trial or would interfere with the&#xD;
               subject's compliance with the trial protocol.&#xD;
  &#xD;
            9. Subjects with active chronic inflammatory bowel disease (e.g. ulcerative colitis,&#xD;
               Crohn's disease) or history of bowel obstruction, gastrointestinal perforation.&#xD;
  &#xD;
           10. Live vaccine was administered within 28 days prior to first dose, or has plan to&#xD;
               receive any kind of live vaccine during this study.&#xD;
  &#xD;
           11. High-dose systemic corticosteroid administration within 2 weeks prior to the first&#xD;
               dose of study drug.&#xD;
  &#xD;
           12. Subjects who were allergic to any composition of investigational drug.&#xD;
  &#xD;
           13. Prior autologous or allogeneic organ transplantation (except corneal transplantation)&#xD;
               or stem cell transplantation prior to the first dose of study drug.&#xD;
  &#xD;
           14. Subjects participate in other clinical trials such as medicine or medical device and&#xD;
               use them within 28 days before the first dose.&#xD;
  &#xD;
           15. Has a history of substance abuse, alcohol or drug abuse, or psychiatric illness.&#xD;
  &#xD;
           16. Women who are pregnant or breastfeeding.&#xD;
  &#xD;
           17. Other conditions deemed ineligible for this study by the investigator.&#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_official>
      <last_name>Zhang Jian, Professor</last_name>
      <role>Principal Investigator</role>
      <affiliation>Fudan University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Zhang Jian, Professor</last_name>
      <phone>18017312991</phone>
      <email>syner2000@163.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Fudan University Shanghai Cancer Centel</name>
        <address>
          <city>Shanghai</city>
          <zip>201210</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Zhang Jian, Professor</last_name>
        <phone>+86 18017312991</phone>
        <email>syner2000@163.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 31, 2023</study_first_submitted>
    <study_first_submitted_qc>August 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 29, 2023</last_update_submitted>
    <last_update_submitted_qc>August 29, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 30, 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/NCT05990452
  org study id: 9MW2921-2023-CP101
  nct id: NCT05990452
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This is an open-label, Phase I-II, first-in-human (FIH) study of 9MW2921 in patients with
        locally advanced or metastatic solid tumors refractory to all standard therapies. The
        objective of this study is to evaluate the safety, tolerability, PK, immunogenicity and
        Preliminary Antitumor Activity of 9MW2921.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Dose Limited Toxicity (DLT)
  time frame: 21 Days (first cycle)
  description: To determine the dose limiting toxicities (DLTs) of 9MW2921
  measure: Adverse Events and Serious Adverse Events
  time frame: up to 2 years or intolerable toxicity, disease progression or death, patient withdrawal of informed consent, withdrawal from the study and so on
  description: Percentage of patients with adverse events (AEs) and serious adverse events (SAEs)
  measure: ORR
  time frame: up to 2 years or intolerable toxicity, disease progression or death, patient withdrawal of informed consent, withdrawal from the study and so on
  description: Defined as the percentage of subjects who experience a best response of either CR or PR.
  measure: PK Parameters: Cmax
  time frame: 1 years
  description: Maximum concentration(Cmax)
  measure: PK Parameters: AUC
  time frame: 1 years
  description: The area under the curve (AUC)
  measure: PK Parameters: t1/2
  time frame: 1 years
  description: The half life(t1/2)
  measure: Incidence of ADAs Against 9MW2921
  time frame: up to 2 years
  description: The incidence of ADAs against 9MW2921 during the study will be summarized
  measure: Progression free survival(PFS) according to RECIST 1.1
  time frame: up to 2 years or intolerable toxicity, disease progression or death, patient withdrawal of informed consent, withdrawal from the study and so on
  description: Time from the date of first infusion to the earliest date of documented disease progression per radiological evidence or death from any cause
  measure: Duration of Response (DoR) according to RECIST 1.1
  time frame: up to 2 years or intolerable toxicity, disease progression or death, patient withdrawal of informed consent, withdrawal from the study and so on
  description: Time from the date of the first complete response (CR) or partial response (PR) to the earliest date of disease progression or death from any cause. DOR is only defined for subjects who have best overall response of CR or PR.
  measure: Disease Control Rate (DCR) according to RECIST 1.1
  time frame: up to 2 years or intolerable toxicity, disease progression or death, patient withdrawal of informed consent, withdrawal from the study and so on
  description: Defined as the percentage of subjects who experience a best response of CR, PR or stable disease (SD).
  arm group label: 9MW2921
  arm group type: Experimental
  intervention type: Drug
  intervention name: 9MW2921
  description: All subjects will receive 9MW2921 by intravenous (IV) every 3 weeks.
  arm group label: 9MW2921
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Zhang Jian, Professor
  role: Principal Investigator
  affiliation: Fudan University
  last name: Zhang Jian, Professor
  phone: 18017312991
  email: syner2000@163.com
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Sponsor
  mesh term: Neoplasms
  sharing ipd: No