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/NCT05991349</url>
    </required_header>
    <id_info>
      <org_study_id>CIBI129A101</org_study_id>
      <nct_id>NCT05991349</nct_id>
    </id_info>
    <brief_title>A Study of IBI129 in Subjects With Unresectable, Locally Advanced or Metastatic Solid Tumors</brief_title>
    <official_title>A Phase 1/2 Study of IBI129 in Subjects With Unresectable, Locally Advanced or Metastatic Solid Tumors</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Innovent Biologics (Suzhou) Co. Ltd.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Innovent Biologics (Suzhou) 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 phase 1/2 multicenter, first-in-human study of IBI129. It includes a phase 1 dose&#xD;
        escalation and expansion section to identify MTD/RP2D of IBI129, plan to enroll 22~180&#xD;
        subjects, and a phase 2 to explore efficacy, safety and tolerability of IBI129 at RP2D in&#xD;
        specified types of solid tumor. Approximately 182 evaluable subjects will be enrolled for&#xD;
        phase 2&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">December 1, 2023</start_date>
    <completion_date type="Anticipated">May 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">November 30, 2024</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>Number of subjects with adverse events</measure>
      <time_frame>24 months</time_frame>
      <description>Occurrence and severity of adverse events (AEs), with severity determined by NCI CTCAE v5.0 criteria</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of subjects with clinically significant changes in physical examination results</measure>
      <time_frame>24 months</time_frame>
      <description>Clinically significant abnormal physical examination findings reported by the investigator.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of subjects with clinically significant changes in vital signs</measure>
      <time_frame>24 months</time_frame>
      <description>Vital signs including body temperature, pulse, respiratory rate, SpO2 and blood pressure</description>
    </primary_outcome>
    <primary_outcome>
      <measure>MTD or RP2D of IBI129</measure>
      <time_frame>12 months</time_frame>
      <description>Number of subjects with dose-limiting toxicities (DLTs)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Plasma concentration (Cmax) of IBI129</measure>
      <time_frame>12 months</time_frame>
      <description>Plasma concentration of IBI129 for single and multiple doses.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Area under the curve (AUC) of IBI129</measure>
      <time_frame>12 months</time_frame>
      <description>AUC of IBI129 for single and multiple doses.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to maximum concentration (Tmax) of IBI129</measure>
      <time_frame>12 months</time_frame>
      <description>Tmax of IBI129 for single and multiple doses.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Clearance (CL) of IBI129</measure>
      <time_frame>12 months</time_frame>
      <description>Clearance of IBI129 from the plasma</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Volume of distribution (V) of IBI129</measure>
      <time_frame>12 months</time_frame>
      <description>Apparent volume of distribution of IBI129.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Half-life (T1/2) of IBI129</measure>
      <time_frame>12 months</time_frame>
      <description>T1/2 of IBI129 for single and multiple doses.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Immunogenicity of IBI129</measure>
      <time_frame>12 months</time_frame>
      <description>Incidence of anti-drug (IBI129) antibody</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Objective response rate (ORR)</measure>
      <time_frame>24 months</time_frame>
      <description>ORR as evaluated per the RECIST v1.1 criteria</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Duration of response (DoR)</measure>
      <time_frame>24 months</time_frame>
      <description>DoR as evaluated per the RECIST v1.1 criteria</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Disease control rate (DCR)</measure>
      <time_frame>24 months</time_frame>
      <description>DCR as evaluated per the RECIST v1.1 criteria</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to response (TTR)</measure>
      <time_frame>24 months</time_frame>
      <description>TTR as evaluated per the RECIST v1.1 criteria</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Progression free survival (PFS)</measure>
      <time_frame>24 months</time_frame>
      <description>PFS as evaluated per the RECIST v1.1 criteria</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Overall survival (OS)</measure>
      <time_frame>24 months</time_frame>
      <description>Overall survival.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">180</enrollment>
    <condition>Solid Tumor</condition>
    <arm_group>
      <arm_group_label>IBI129</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>IBI129</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>IBI129</intervention_name>
      <description>Subjects will receive IBI129 on Day 1 of a 21-day cycle (or intervals determined by the Investigator and Sponsor based on safety, toxicity and PK data), until unacceptable toxicity, disease progression, withdrawal of consent, occurrence of other reasons for discontinuing study therapy, or for a maximum of 24 months of treatment, whichever occurs first.</description>
      <arm_group_label>IBI129</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Subjects with the ability to understand and give written informed consent for&#xD;
               participation in this trial, including all evaluations and procedures as specified by&#xD;
               this protocol;&#xD;
  &#xD;
            2. At least 1 evaluable lesion according to Response Evaluation Criteria in Solid Tumors&#xD;
               (RECIST) Version 1.1.;&#xD;
  &#xD;
            3. Male or female subjects ≥ 18 years old;&#xD;
  &#xD;
            4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1;&#xD;
  &#xD;
            5. Anticipated life expectancy of ≥ 12 weeks;&#xD;
  &#xD;
            6. Adequate bone marrow and organ function&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Participate in any other interventional clinical research except observational&#xD;
               (non-interventional) study or in the follow-up phase of the interventional study;&#xD;
  &#xD;
            2. Received previous anti-tumor therapy within 4 weeks or 5 half-lives of the anti-tumor&#xD;
               regimens before the first administration of study drug, whichever is shorter.&#xD;
  &#xD;
            3. Progressed refractory to an antibody drug conjugate that consists of an exatecan&#xD;
               derivative that is a topoisomerase I inhibitor.&#xD;
  &#xD;
            4. Plan to receive other antitumor therapy during the study excluding palliative&#xD;
               radiotherapy for the purpose of symptom (like pain) relief that must also do not have&#xD;
               impact on tumor assessment throughout the study;&#xD;
  &#xD;
            5. Known symptomatic central nervous system (CNS) metastases.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Serena Dong</last_name>
      <phone>051269566088</phone>
      <email>suhua.dong@innoventbio.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>St George private Hospital</name>
        <address>
          <city>Sydney</city>
          <state>New South Wales</state>
          <zip>2217</zip>
          <country>Austria</country>
        </address>
      </facility>
      <contact>
        <last_name>Paul Souza</last_name>
        <phone>+612 9598 5022</phone>
        <email>P.DeSouza@westernsydney.edu.au</email>
      </contact>
    </location>
    <location_countries>
      <country>Austria</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 25, 2023</study_first_submitted>
    <study_first_submitted_qc>August 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 6, 2023</last_update_submitted>
    <last_update_submitted_qc>August 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 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/NCT05991349
  org study id: CIBI129A101
  nct id: NCT05991349
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This is a phase 1/2 multicenter, first-in-human study of IBI129. It includes a phase 1 dose
        escalation and expansion section to identify MTD/RP2D of IBI129, plan to enroll 22~180
        subjects, and a phase 2 to explore efficacy, safety and tolerability of IBI129 at RP2D in
        specified types of solid tumor. Approximately 182 evaluable subjects will be enrolled for
        phase 2
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Number of subjects with adverse events
  time frame: 24 months
  description: Occurrence and severity of adverse events (AEs), with severity determined by NCI CTCAE v5.0 criteria
  measure: Number of subjects with clinically significant changes in physical examination results
  time frame: 24 months
  description: Clinically significant abnormal physical examination findings reported by the investigator.
  measure: Number of subjects with clinically significant changes in vital signs
  time frame: 24 months
  description: Vital signs including body temperature, pulse, respiratory rate, SpO2 and blood pressure
  measure: MTD or RP2D of IBI129
  time frame: 12 months
  description: Number of subjects with dose-limiting toxicities (DLTs)
  measure: Plasma concentration (Cmax) of IBI129
  time frame: 12 months
  description: Plasma concentration of IBI129 for single and multiple doses.
  measure: Area under the curve (AUC) of IBI129
  time frame: 12 months
  description: AUC of IBI129 for single and multiple doses.
  measure: Time to maximum concentration (Tmax) of IBI129
  time frame: 12 months
  description: Tmax of IBI129 for single and multiple doses.
  measure: Clearance (CL) of IBI129
  time frame: 12 months
  description: Clearance of IBI129 from the plasma
  measure: Volume of distribution (V) of IBI129
  time frame: 12 months
  description: Apparent volume of distribution of IBI129.
  measure: Half-life (T1/2) of IBI129
  time frame: 12 months
  description: T1/2 of IBI129 for single and multiple doses.
  measure: Immunogenicity of IBI129
  time frame: 12 months
  description: Incidence of anti-drug (IBI129) antibody
  measure: Objective response rate (ORR)
  time frame: 24 months
  description: ORR as evaluated per the RECIST v1.1 criteria
  measure: Duration of response (DoR)
  time frame: 24 months
  description: DoR as evaluated per the RECIST v1.1 criteria
  measure: Disease control rate (DCR)
  time frame: 24 months
  description: DCR as evaluated per the RECIST v1.1 criteria
  measure: Time to response (TTR)
  time frame: 24 months
  description: TTR as evaluated per the RECIST v1.1 criteria
  measure: Progression free survival (PFS)
  time frame: 24 months
  description: PFS as evaluated per the RECIST v1.1 criteria
  measure: Overall survival (OS)
  time frame: 24 months
  description: Overall survival.
  arm group label: IBI129
  arm group type: Experimental
  description: IBI129
  intervention type: Drug
  intervention name: IBI129
  description: Subjects will receive IBI129 on Day 1 of a 21-day cycle (or intervals determined by the Investigator and Sponsor based on safety, toxicity and PK data), until unacceptable toxicity, disease progression, withdrawal of consent, occurrence of other reasons for discontinuing study therapy, or for a maximum of 24 months of treatment, whichever occurs first.
  arm group label: IBI129
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Serena Dong
  phone: 051269566088
  email: suhua.dong@innoventbio.com
  facility: 
  contact: 
  country: Austria
  responsible party type: Sponsor
  mesh term: Neoplasms
  sharing ipd: No