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/NCT06014190</url>
    </required_header>
    <id_info>
      <org_study_id>HS-20089-201</org_study_id>
      <nct_id>NCT06014190</nct_id>
    </id_info>
    <brief_title>HS-20089 in Patients With Ovarian Cancer and Endometrial Cancer</brief_title>
    <official_title>A Phase 2 Study of HS-20089 for Injection in Patients With Recurrent or Metastatic Ovarian Cancer and Endometrial Cancer</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Hansoh BioMedical R&amp;D Company</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Hansoh BioMedical R&amp;D Company</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>
        HS-20089 is an investigational antibody-drug conjugate (ADC) composed of a humanized IgG1&#xD;
        anti-B7-H4 monoclonal antibody conjugated to the topoisomerase I inhibitor payload via a&#xD;
        protease-cleavable linker, with an average drug-to-antibody ratio of about 6.&#xD;
  &#xD;
        This is a phase 2, open-label, multi-center study to evaluate the efficacy, safety,&#xD;
        pharmacokinetics (PK) and immunogenicity of HS-20089 as monotherapy in patients with&#xD;
        recurrent or metastatic ovarian cancer and endometrial cancer.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a phase 2, open-label, multi-center study composed of two parts: phase 2a and phase&#xD;
        2b.&#xD;
  &#xD;
        Phase 2a: This part of study will be conducted in the following four cohorts: Cohort 1:&#xD;
        Patients with platinum-resistant ovarian cancer, fallopian tube cancer or primary peritoneal&#xD;
        cancer. Cohort 2: Patients with recurrent or metastatic endometrial cancer who have&#xD;
        progressed on or are intolerant to at least one line of standard platinum-based chemotherapy.&#xD;
        Cohort 3: Patients with platinum-sensitive ovarian cancer, fallopian tube cancer or primary&#xD;
        peritoneal cancer who have progressed on or are intolerant to at least two lines of standard&#xD;
        platinum-based chemotherapy. Cohort 4: Patients with other advanced solid tumors who have&#xD;
        progressed on or are intolerant to established standard therapies. Patients in cohort 1 will&#xD;
        be randomly assigned 1:1 to receive HS-20089 at 4.8 mg/kg or 5.8 mg/kg and patients in the&#xD;
        other three cohorts will receive HS-20089 at 5.8 mg/kg.&#xD;
  &#xD;
        Phase 2b: This part of study will be conducted in the following two cohorts: Cohort 1:&#xD;
        Patients with platinum-resistant ovarian cancer, fallopian tube cancer or primary peritoneal&#xD;
        cancer. Cohort 2: Patients with recurrent or metastatic endometrial cancer who have&#xD;
        progressed on or are intolerant to at least one line of standard platinum-based chemotherapy.&#xD;
        The cohorts may be adjusted based on the observed clinical results, translational medicine&#xD;
        data and research progress in the field. All patients will receive HS-20089 at the&#xD;
        recommended dose (RD) determined by accumulated research data.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">December 31, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2027</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2025</primary_completion_date>
    <phase>Phase 2</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Objective response rate (ORR) assessed by investigators according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1</measure>
      <time_frame>From the first dose up to disease progression or withdrawal from study, whichever came first, assessed up to 24 months.</time_frame>
      <description>ORR is defined as the percentage of participants who achieved a best overall response (BOR) of confirmed complete response (CR) or partial response (PR), assessed by investigators based on RECIST 1.1.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>ORR assessed by independent review committee (IRC) according to RECIST 1.1</measure>
      <time_frame>From the first dose to disease progression or withdrawal from study, whichever came first, assessed up to 24 months.</time_frame>
      <description>ORR is defined as the percentage of participants who achieved a BOR of confirmed CR or PR, assessed by IRC based on RECIST 1.1.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Duration of response (DoR) assessed by investigators and IRC according to RECIST 1.1</measure>
      <time_frame>From the first dose to disease progression or withdrawal from study, whichever came first, assessed up to 24 months.</time_frame>
      <description>DoR is defined as the period from the first occurrence of CR or PR to progressive disease (PD) or death of any cause. If no PD or death after CR/PR, the cut-off date of progression-free survival (PFS) will be used.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Disease control rate (DCR) assessed by investigators and IRC according to RECIST 1.1</measure>
      <time_frame>From the first dose to disease progression or withdrawal from study, whichever came first, assessed up to 24 months.</time_frame>
      <description>DCR is defined as the percentage of participants with BOR of confirmed CR, PR and stable disease (SD).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Progression-free survival (PFS) assessed by investigators and IRC according to RECIST 1.1</measure>
      <time_frame>From the first dose or randomization to disease progression or withdrawal from study, whichever came first, assessed up to 24 months.</time_frame>
      <description>PFS is defined as the time from first dose or randomization (if any) to PD or death of any cause.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Overall survival (OS)</measure>
      <time_frame>From the first dose or randomization to death or withdrawal from study, whichever came first, assessed up to 24 months.</time_frame>
      <description>OS is defined as the time from the first dose or randomization (if any) to death of any cause.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>ORR assessed by investigators (combined criteria incorporating RECIST 1.1 and Gynecological Cancer Intergroup [GCIG]) CA-125 criteria; Ovarian cancer only)</measure>
      <time_frame>From the first dose to disease progression or withdrawal from study, whichever came first, assessed up to 24 months.</time_frame>
      <description>Defined as the proportion of subjects with confirmed CR or PR before progression as assessed by incorporating both RECIST 1.1 and GCIG CA-125 criteria.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>CA-125 response rate assessed by investigators according to GCIG CA-125 criteria (ovarian cancer only)</measure>
      <time_frame>From the first dose to disease progression or withdrawal from study, whichever came first, assessed up to 24 months.</time_frame>
      <description>CA-125 response rate is defined as the proportion of subjects with GCIG CA-125 criteria defined CA-125 response, which will be assessed in a subset of subjects with a baseline CA-125 level of at least twice the ULN as evaluable.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence and severity of adverse events (AEs)</measure>
      <time_frame>From the first dose to 90 days after the end of treatment.</time_frame>
      <description>AEs will be graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0. The incidence and severity of AEs will be calculated and summarized.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Observed maximum plasma concentration (Cmax) of HS-20089</measure>
      <time_frame>From pre-dose to 14 days after the first dose of HS-20089 on Cycle 1 (each cycle is 21 days).</time_frame>
      <description>Cmax will be obtained following administration of the first dose of HS-20089 during the first cycle.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to reach maximum plasma concentration (Tmax) of HS-20089 following the first dose</measure>
      <time_frame>From pre-dose to 14 days after the first dose on Cycle 1 (each cycle is 21 days).</time_frame>
      <description>Tmax will be obtained following administration of the first dose of HS-20089 during the first cycle.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Area under plasma concentration versus time curve from zero to last sampling time (AUC0-t) following the first dose of HS-20089</measure>
      <time_frame>From pre-dose to 14 days after the first dose on Cycle 1 (each cycle is 21 days).</time_frame>
      <description>Area under the plasma concentration versus time curve from time zero to the last sampling time when the concentration is no less than the lower limit of quantification (LLQ). AUC0-t will be calculated according to the mixed log-linear trapezoidal rule.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Area under the plasma concentration versus time curve from time zero to infinity (AUC0-∞) after single dose of HS-20089</measure>
      <time_frame>From pre-dose to 14 days after the first dose on Cycle 1 (each cycle is 21 days).</time_frame>
      <description>AUC0-∞ will be calculated by combining AUC0-t and AUCextra. AUCextra represents an extrapolated value obtained by Clast/ λz, where Clast is the calculated plasma concentration at the last sampling time point at which the measured plasma concentration is at or above the LLQ and λz is the apparent terminal rate constant determined by log-linear regression analysis of the measured plasma concentrations of the terminal log-linear phase.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percentage of participants with antibodies to HS-20089 in serum</measure>
      <time_frame>From the first dose to 90 days after the end of treatment.</time_frame>
      <description>Serum samples will be collected for the determination of anti-drug antibody (ADA) at designated time points.</description>
    </secondary_outcome>
    <number_of_arms>6</number_of_arms>
    <enrollment type="Anticipated">460</enrollment>
    <condition>Ovarian Cancer</condition>
    <condition>Fallopian Tube Cancer</condition>
    <condition>Primary Peritoneal Cancer</condition>
    <condition>Endometrial Cancer</condition>
    <arm_group>
      <arm_group_label>Cohort 1 at 4.8 mg/kg of HS-20089 (Phase 2a)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients in cohort 1 of phase 2a will be randomly assigned to receive HS-20089 at 4.8 mg/kg or 5.8 mg/kg.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Cohort 1 at 5.8 mg/kg of HS-20089 (Phase 2a)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients in cohort 1 of phase 2a will be randomly assigned to receive HS-20089 at 4.8 mg/kg or 5.8 mg/kg.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Cohort 2 at 5.8 mg/kg of HS-20089 (Phase 2a)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients in cohort 2 of phase 2a will receive HS-20089 at 5.8 mg/kg.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Cohort 3 at 5.8 mg/kg of HS-20089 (Phase 2a)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients in cohort 3 of phase 2a will receive HS-20089 at 5.8 mg/kg.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Cohort 4 at 5.8 mg/kg of HS-20089 (Phase 2a)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients in cohort 4 of phase 2a will receive HS-20089 at 5.8 mg/kg.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Recommended dose of HS-20089 (Phase 2b)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients of phase 2b will receive HS-20089 at recommended dose.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>HS-20089</intervention_name>
      <description>All patients will receive intravenous HS-20089 once every three weeks (Q3W) until experiencing objective disease progression (except for study drug treatment beyond progression) or meeting other protocol-specified criteria of study treatment discontinuation.</description>
      <arm_group_label>Cohort 1 at 4.8 mg/kg of HS-20089 (Phase 2a)</arm_group_label>
      <arm_group_label>Cohort 1 at 5.8 mg/kg of HS-20089 (Phase 2a)</arm_group_label>
      <arm_group_label>Cohort 2 at 5.8 mg/kg of HS-20089 (Phase 2a)</arm_group_label>
      <arm_group_label>Cohort 3 at 5.8 mg/kg of HS-20089 (Phase 2a)</arm_group_label>
      <arm_group_label>Cohort 4 at 5.8 mg/kg of HS-20089 (Phase 2a)</arm_group_label>
      <arm_group_label>Recommended dose of HS-20089 (Phase 2b)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Males or females aged 18 years or older (≥18 years).&#xD;
  &#xD;
            2. Patients diagnosed with recurrent or metastatic ovarian cancer, endometrial cancer or&#xD;
               other solid tumors.&#xD;
  &#xD;
            3. Subjects have at least one target lesion as assessed per the RECIST 1.1. Patients with&#xD;
               only brain and/or bone lesions as target lesions are ineligible.&#xD;
  &#xD;
            4. Tumor tissue from a newly obtained biopsy (FFPE tumor tissue blocks or slides are&#xD;
               acceptable) is required. If the newly obtained biopsy is not feasible, newly obtained&#xD;
               FFPE slides cut from archival tumor tissue blocks within 2 years prior to the first&#xD;
               dose of study drug are acceptable.&#xD;
  &#xD;
            5. Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 to 1 and no&#xD;
               deterioration within 2 weeks before the first dose.&#xD;
  &#xD;
            6. Have a life expectancy of at least 12 weeks.&#xD;
  &#xD;
            7. Female subjects of childbearing potential are willing to take appropriate&#xD;
               contraceptive measures and should not breastfeed from signing the informed consent&#xD;
               until 6 months after the last dose; male subjects must agree to use barrier&#xD;
               contraception (i.e. condoms) from signing the informed consent to 6 months after the&#xD;
               last dose.&#xD;
  &#xD;
            8. Female subjects must have a negative pregnancy test within 7 days prior to the first&#xD;
               dose (for subjects with tumor related abnormal elevation of human chorionic&#xD;
               gonadotropin [HCG], an ultrasound of uterus and appendages should be performed within&#xD;
               7 days prior to the first dose to rule out pregnancy), or demonstrate no risk for&#xD;
               pregnancy.&#xD;
  &#xD;
            9. Subject must be voluntarily enrolled in this clinical trial, be able to understand the&#xD;
               study procedures and to sign written informed consent.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Have received or is currently receiving the following treatment:&#xD;
  &#xD;
                 1. B7-H4-targeted therapies.&#xD;
  &#xD;
                 2. Have received any of cytotoxic chemotherapy drugs, investigational drugs,&#xD;
                    anti-tumor traditional Chinese medicines or other anti-tumor drugs (including&#xD;
                    endocrine therapy, molecular targeted therapy, biotherapy, etc.) within 14 days&#xD;
                    prior to the first dose of study drug; or need to continue these drugs during the&#xD;
                    study.&#xD;
  &#xD;
                 3. Have received macromolecular antitumor drugs (including immunotherapy, such as&#xD;
                    monoclonal antibodies and bispecific antibodies) within 28 days prior to the&#xD;
                    first dose of study drug.&#xD;
  &#xD;
                 4. Have received locoregional radiation therapy within 2 weeks prior to the first&#xD;
                    dose of study drug; more than 30% of bone marrow irradiation or wide-field&#xD;
                    radiation therapy within 4 weeks prior to the first dose of study treatment.&#xD;
  &#xD;
                 5. Major surgery (such as craniotomy, thoracotomy or laparotomy, etc.) within 4&#xD;
                    weeks prior to the first dose of study treatment.&#xD;
  &#xD;
                 6. Use of strong inhibitors or inducers of CYP3A4, CYP2D6, P-gp, or BCRP, or&#xD;
                    sensitive substrates of CYP3A4, CYP2D6, P-gp, or BCRP with narrow therapeutic&#xD;
                    window within 7 days prior to the first dose of study drug; or in need of&#xD;
                    continuing treatment with these drugs during the study.&#xD;
  &#xD;
                 7. Current use of drugs known to prolong the QT interval or potentially cause&#xD;
                    torsades de pointes; or need to continue these medications during the study.&#xD;
  &#xD;
            2. Presence of Grade ≥ 2 toxicities as per Common Terminology Criteria for Adverse Events&#xD;
               (CTCAE version 5.0) due to prior anti-tumor therapy (except alopecia and residual&#xD;
               neurotoxicity).&#xD;
  &#xD;
            3. Presence of pleural/abdominal effusion requiring clinical intervention.&#xD;
  &#xD;
            4. Known history of prior malignancy.&#xD;
  &#xD;
            5. Evidence of brain metastasis, unless meeting all of the following criteria:&#xD;
  &#xD;
                 1. Asymptomatic; medically stable for at least four weeks prior to the first dose;&#xD;
  &#xD;
                 2. No steroid treatment required for at least two weeks prior to the first dose;&#xD;
  &#xD;
                 3. No stereotactic radiation therapy, whole brain radiotherapy, and/or neurosurgical&#xD;
                    resection within 4 weeks prior to the first dose;&#xD;
  &#xD;
                 4. No history of intracranial or spinal hemorrhage;&#xD;
  &#xD;
                 5. Have at least one target lesion other than CNS lesion according to RECIST v1.1;&#xD;
  &#xD;
            6. Inadequate bone marrow reserve or hepatic/renal functions.&#xD;
  &#xD;
            7. Cardiological examination abnormality.&#xD;
  &#xD;
            8. Severe, uncontrolled or active cardiovascular disorders.&#xD;
  &#xD;
            9. Serious or poorly controlled diabetes.&#xD;
  &#xD;
           10. Serious or poorly controlled hypertension.&#xD;
  &#xD;
           11. Clinically significant bleeding symptoms or significant bleeding tendency within 1&#xD;
               month prior to the first dose of study treatment.&#xD;
  &#xD;
           12. Serious arteriovenous thromboembolic events within 3 months prior to the first dose of&#xD;
               study treatment.&#xD;
  &#xD;
           13. Serious infections within 4 weeks prior to the first dose.&#xD;
  &#xD;
           14. Have received systemic glucocorticoid therapy for more than 30 days within 30 days&#xD;
               prior to the first dose study treatment, or require chronic (≥ 30 days) use of&#xD;
               systemic glucocorticoids during the study, or have other acquired, congenital&#xD;
               immunodeficiency disorders, or a history of organ transplantation.&#xD;
  &#xD;
           15. Presence of active infectious diseases such as hepatitis B, hepatitis C, tuberculosis,&#xD;
               syphilis, or human immunodeficiency virus infection, etc.&#xD;
  &#xD;
           16. Current hepatic encephalopathy, hepatorenal syndrome, or Child-Pugh Class B or more&#xD;
               severe cirrhosis.&#xD;
  &#xD;
           17. Any moderate or severe lung diseases that may interfere with the detection and&#xD;
               treatment of drug-related pulmonary toxicity or may seriously affect respiratory&#xD;
               function.&#xD;
  &#xD;
           18. History of severe neurological or psychiatric disorder.&#xD;
  &#xD;
           19. Pregnant or breast-feeding women or women who intend to become pregnant during the&#xD;
               study.&#xD;
  &#xD;
           20. Attenuated live vaccination within 4 weeks prior to the first dose.&#xD;
  &#xD;
           21. Allergies or hypersensitivity reactions within 4 weeks prior to the first dose.&#xD;
               History of severe allergies (e.g., anaphylactic shock), or severe infusion-related&#xD;
               reactions. Allergy or hypersensitivity to any component of HS-20089.&#xD;
  &#xD;
           22. Subjects unlikely to comply with study procedures, restrictions and requirement as&#xD;
               determined by the investigator.&#xD;
  &#xD;
           23. Subjects with any condition that jeopardizes the safety of the patient or interferes&#xD;
               with the assessment of the study, as judged by the investigator.&#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_official>
      <last_name>Lingying Wu, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Qingshui Li</last_name>
      <role>Principal Investigator</role>
      <affiliation>Affiliated Cancer Hospital of Shandong First Medical University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Hui Zhang</last_name>
      <role>Principal Investigator</role>
      <affiliation>The Fourth Hospital of Hebei Medical University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Xin Lu</last_name>
      <role>Principal Investigator</role>
      <affiliation>Hospital of Obstetrics and Gynecology affiliated to Fudan University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Huaijun Zhou</last_name>
      <role>Principal Investigator</role>
      <affiliation>Gulou Hospital Affiliated to Nanjing University School of Medicine</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Hongying Yang</last_name>
      <role>Principal Investigator</role>
      <affiliation>Yunnan Cancer Hospital</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Li Wang</last_name>
      <role>Principal Investigator</role>
      <affiliation>Henan Cancer Hospital</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Ruifang An</last_name>
      <role>Principal Investigator</role>
      <affiliation>The First Affiliated Hospital of Xi 'an Jiaotong University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Jianlin Yuan</last_name>
      <role>Principal Investigator</role>
      <affiliation>Xinjiang Medical University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>An Lin</last_name>
      <role>Principal Investigator</role>
      <affiliation>Fujian Cancer Hospital</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Genhai Zhu</last_name>
      <role>Principal Investigator</role>
      <affiliation>Hainan People's Hospital</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Yu Zhang</last_name>
      <role>Principal Investigator</role>
      <affiliation>Xiangya Hospital of Central South University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Jie Tang</last_name>
      <role>Principal Investigator</role>
      <affiliation>Hunan Cancer Hospital</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Guiling Li</last_name>
      <role>Principal Investigator</role>
      <affiliation>Wuhan Union Hospital, China</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Yi Huang</last_name>
      <role>Principal Investigator</role>
      <affiliation>Hubei Cancer Hospital</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Jieqing Zhang</last_name>
      <role>Principal Investigator</role>
      <affiliation>Affiliated Cancer Hospital of Guangxi Medical University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Lingying Wu, MD</last_name>
      <phone>010-87788996</phone>
      <email>wulingying@csco.org.cn</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Dawei Wu</last_name>
      <phone>010-87788495</phone>
      <email>cancergcp@163.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Lingying Wu</name>
        <address>
          <city>Beijing</city>
          <state>Beijing</state>
          <zip>100020</zip>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Lingying Wu, MD</last_name>
        <phone>010-87788996</phone>
        <email>wulingying@csco.org.cn</email>
      </contact>
      <contact_backup>
        <last_name>Dawei Wu</last_name>
        <phone>010-87788495</phone>
        <email>cancergcp@163.com</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 16, 2023</study_first_submitted>
    <study_first_submitted_qc>August 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 28, 2023</study_first_posted>
    <last_update_submitted>August 22, 2023</last_update_submitted>
    <last_update_submitted_qc>August 22, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>HS-20089</keyword>
    <keyword>B7-H4</keyword>
    <keyword>Antibody-drug Conjugate</keyword>
    <keyword>Ovarian Cancer</keyword>
    <keyword>Endometrial Cancer</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Ovarian Neoplasms</mesh_term>
      <mesh_term>Carcinoma, Ovarian Epithelial</mesh_term>
      <mesh_term>Endometrial Neoplasms</mesh_term>
      <mesh_term>Fallopian Tube 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/NCT06014190
  org study id: HS-20089-201
  nct id: NCT06014190
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  HS-20089 is an investigational antibody-drug conjugate (ADC) composed of a humanized IgG1
        anti-B7-H4 monoclonal antibody conjugated to the topoisomerase I inhibitor payload via a
        protease-cleavable linker, with an average drug-to-antibody ratio of about 6.
  
        This is a phase 2, open-label, multi-center study to evaluate the efficacy, safety,
        pharmacokinetics (PK) and immunogenicity of HS-20089 as monotherapy in patients with
        recurrent or metastatic ovarian cancer and endometrial cancer.
  This is a phase 2, open-label, multi-center study composed of two parts: phase 2a and phase
        2b.
  
        Phase 2a: This part of study will be conducted in the following four cohorts: Cohort 1:
        Patients with platinum-resistant ovarian cancer, fallopian tube cancer or primary peritoneal
        cancer. Cohort 2: Patients with recurrent or metastatic endometrial cancer who have
        progressed on or are intolerant to at least one line of standard platinum-based chemotherapy.
        Cohort 3: Patients with platinum-sensitive ovarian cancer, fallopian tube cancer or primary
        peritoneal cancer who have progressed on or are intolerant to at least two lines of standard
        platinum-based chemotherapy. Cohort 4: Patients with other advanced solid tumors who have
        progressed on or are intolerant to established standard therapies. Patients in cohort 1 will
        be randomly assigned 1:1 to receive HS-20089 at 4.8 mg/kg or 5.8 mg/kg and patients in the
        other three cohorts will receive HS-20089 at 5.8 mg/kg.
  
        Phase 2b: This part of study will be conducted in the following two cohorts: Cohort 1:
        Patients with platinum-resistant ovarian cancer, fallopian tube cancer or primary peritoneal
        cancer. Cohort 2: Patients with recurrent or metastatic endometrial cancer who have
        progressed on or are intolerant to at least one line of standard platinum-based chemotherapy.
        The cohorts may be adjusted based on the observed clinical results, translational medicine
        data and research progress in the field. All patients will receive HS-20089 at the
        recommended dose (RD) determined by accumulated research data.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Objective response rate (ORR) assessed by investigators according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
  time frame: From the first dose up to disease progression or withdrawal from study, whichever came first, assessed up to 24 months.
  description: ORR is defined as the percentage of participants who achieved a best overall response (BOR) of confirmed complete response (CR) or partial response (PR), assessed by investigators based on RECIST 1.1.
  measure: ORR assessed by independent review committee (IRC) according to RECIST 1.1
  time frame: From the first dose to disease progression or withdrawal from study, whichever came first, assessed up to 24 months.
  description: ORR is defined as the percentage of participants who achieved a BOR of confirmed CR or PR, assessed by IRC based on RECIST 1.1.
  measure: Duration of response (DoR) assessed by investigators and IRC according to RECIST 1.1
  time frame: From the first dose to disease progression or withdrawal from study, whichever came first, assessed up to 24 months.
  description: DoR is defined as the period from the first occurrence of CR or PR to progressive disease (PD) or death of any cause. If no PD or death after CR/PR, the cut-off date of progression-free survival (PFS) will be used.
  measure: Disease control rate (DCR) assessed by investigators and IRC according to RECIST 1.1
  time frame: From the first dose to disease progression or withdrawal from study, whichever came first, assessed up to 24 months.
  description: DCR is defined as the percentage of participants with BOR of confirmed CR, PR and stable disease (SD).
  measure: Progression-free survival (PFS) assessed by investigators and IRC according to RECIST 1.1
  time frame: From the first dose or randomization to disease progression or withdrawal from study, whichever came first, assessed up to 24 months.
  description: PFS is defined as the time from first dose or randomization (if any) to PD or death of any cause.
  measure: Overall survival (OS)
  time frame: From the first dose or randomization to death or withdrawal from study, whichever came first, assessed up to 24 months.
  description: OS is defined as the time from the first dose or randomization (if any) to death of any cause.
  measure: ORR assessed by investigators (combined criteria incorporating RECIST 1.1 and Gynecological Cancer Intergroup [GCIG]) CA-125 criteria; Ovarian cancer only)
  time frame: From the first dose to disease progression or withdrawal from study, whichever came first, assessed up to 24 months.
  description: Defined as the proportion of subjects with confirmed CR or PR before progression as assessed by incorporating both RECIST 1.1 and GCIG CA-125 criteria.
  measure: CA-125 response rate assessed by investigators according to GCIG CA-125 criteria (ovarian cancer only)
  time frame: From the first dose to disease progression or withdrawal from study, whichever came first, assessed up to 24 months.
  description: CA-125 response rate is defined as the proportion of subjects with GCIG CA-125 criteria defined CA-125 response, which will be assessed in a subset of subjects with a baseline CA-125 level of at least twice the ULN as evaluable.
  measure: Incidence and severity of adverse events (AEs)
  time frame: From the first dose to 90 days after the end of treatment.
  description: AEs will be graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0. The incidence and severity of AEs will be calculated and summarized.
  measure: Observed maximum plasma concentration (Cmax) of HS-20089
  time frame: From pre-dose to 14 days after the first dose of HS-20089 on Cycle 1 (each cycle is 21 days).
  description: Cmax will be obtained following administration of the first dose of HS-20089 during the first cycle.
  measure: Time to reach maximum plasma concentration (Tmax) of HS-20089 following the first dose
  time frame: From pre-dose to 14 days after the first dose on Cycle 1 (each cycle is 21 days).
  description: Tmax will be obtained following administration of the first dose of HS-20089 during the first cycle.
  measure: Area under plasma concentration versus time curve from zero to last sampling time (AUC0-t) following the first dose of HS-20089
  time frame: From pre-dose to 14 days after the first dose on Cycle 1 (each cycle is 21 days).
  description: Area under the plasma concentration versus time curve from time zero to the last sampling time when the concentration is no less than the lower limit of quantification (LLQ). AUC0-t will be calculated according to the mixed log-linear trapezoidal rule.
  measure: Area under the plasma concentration versus time curve from time zero to infinity (AUC0-∞) after single dose of HS-20089
  time frame: From pre-dose to 14 days after the first dose on Cycle 1 (each cycle is 21 days).
  description: AUC0-∞ will be calculated by combining AUC0-t and AUCextra. AUCextra represents an extrapolated value obtained by Clast/ λz, where Clast is the calculated plasma concentration at the last sampling time point at which the measured plasma concentration is at or above the LLQ and λz is the apparent terminal rate constant determined by log-linear regression analysis of the measured plasma concentrations of the terminal log-linear phase.
  measure: Percentage of participants with antibodies to HS-20089 in serum
  time frame: From the first dose to 90 days after the end of treatment.
  description: Serum samples will be collected for the determination of anti-drug antibody (ADA) at designated time points.
  arm group label: Cohort 1 at 4.8 mg/kg of HS-20089 (Phase 2a)
  arm group type: Experimental
  description: Patients in cohort 1 of phase 2a will be randomly assigned to receive HS-20089 at 4.8 mg/kg or 5.8 mg/kg.
  arm group label: Cohort 1 at 5.8 mg/kg of HS-20089 (Phase 2a)
  arm group type: Experimental
  description: Patients in cohort 1 of phase 2a will be randomly assigned to receive HS-20089 at 4.8 mg/kg or 5.8 mg/kg.
  arm group label: Cohort 2 at 5.8 mg/kg of HS-20089 (Phase 2a)
  arm group type: Experimental
  description: Patients in cohort 2 of phase 2a will receive HS-20089 at 5.8 mg/kg.
  arm group label: Cohort 3 at 5.8 mg/kg of HS-20089 (Phase 2a)
  arm group type: Experimental
  description: Patients in cohort 3 of phase 2a will receive HS-20089 at 5.8 mg/kg.
  arm group label: Cohort 4 at 5.8 mg/kg of HS-20089 (Phase 2a)
  arm group type: Experimental
  description: Patients in cohort 4 of phase 2a will receive HS-20089 at 5.8 mg/kg.
  arm group label: Recommended dose of HS-20089 (Phase 2b)
  arm group type: Experimental
  description: Patients of phase 2b will receive HS-20089 at recommended dose.
  intervention type: Drug
  intervention name: HS-20089
  description: All patients will receive intravenous HS-20089 once every three weeks (Q3W) until experiencing objective disease progression (except for study drug treatment beyond progression) or meeting other protocol-specified criteria of study treatment discontinuation.
  arm group label: Cohort 1 at 4.8 mg/kg of HS-20089 (Phase 2a)
  arm group label: Cohort 1 at 5.8 mg/kg of HS-20089 (Phase 2a)
  arm group label: Cohort 2 at 5.8 mg/kg of HS-20089 (Phase 2a)
  arm group label: Cohort 3 at 5.8 mg/kg of HS-20089 (Phase 2a)
  arm group label: Cohort 4 at 5.8 mg/kg of HS-20089 (Phase 2a)
  arm group label: Recommended dose of HS-20089 (Phase 2b)
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Lingying Wu, MD
  role: Principal Investigator
  affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
  last name: Qingshui Li
  role: Principal Investigator
  affiliation: Affiliated Cancer Hospital of Shandong First Medical University
  last name: Hui Zhang
  role: Principal Investigator
  affiliation: The Fourth Hospital of Hebei Medical University
  last name: Xin Lu
  role: Principal Investigator
  affiliation: Hospital of Obstetrics and Gynecology affiliated to Fudan University
  last name: Huaijun Zhou
  role: Principal Investigator
  affiliation: Gulou Hospital Affiliated to Nanjing University School of Medicine
  last name: Hongying Yang
  role: Principal Investigator
  affiliation: Yunnan Cancer Hospital
  last name: Li Wang
  role: Principal Investigator
  affiliation: Henan Cancer Hospital
  last name: Ruifang An
  role: Principal Investigator
  affiliation: The First Affiliated Hospital of Xi 'an Jiaotong University
  last name: Jianlin Yuan
  role: Principal Investigator
  affiliation: Xinjiang Medical University
  last name: An Lin
  role: Principal Investigator
  affiliation: Fujian Cancer Hospital
  last name: Genhai Zhu
  role: Principal Investigator
  affiliation: Hainan People's Hospital
  last name: Yu Zhang
  role: Principal Investigator
  affiliation: Xiangya Hospital of Central South University
  last name: Jie Tang
  role: Principal Investigator
  affiliation: Hunan Cancer Hospital
  last name: Guiling Li
  role: Principal Investigator
  affiliation: Wuhan Union Hospital, China
  last name: Yi Huang
  role: Principal Investigator
  affiliation: Hubei Cancer Hospital
  last name: Jieqing Zhang
  role: Principal Investigator
  affiliation: Affiliated Cancer Hospital of Guangxi Medical University
  last name: Lingying Wu, MD
  phone: 010-87788996
  email: wulingying@csco.org.cn
  last name: Dawei Wu
  phone: 010-87788495
  email: cancergcp@163.com
  facility: 
  contact: 
  contact backup: 
  country: China
  responsible party type: Sponsor
  mesh term: Ovarian Neoplasms
  mesh term: Carcinoma, Ovarian Epithelial
  mesh term: Endometrial Neoplasms
  mesh term: Fallopian Tube Neoplasms