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/NCT06040970</url>
    </required_header>
    <id_info>
      <org_study_id>STUDY-22-00832</org_study_id>
      <nct_id>NCT06040970</nct_id>
    </id_info>
    <brief_title>Sacituzumab Govitecan in Combination With Cisplatin in Platinum Sensitive Recurrent Ovarian and Endometrial Cancer</brief_title>
    <official_title>A Single-Center, Open-Label, Single-Arm, Phase I Study With Dose Expansion Cohort of Sacituzumab Govitecan in Combination With Cisplatin in Platinum Sensitive Recurrent Ovarian and Endometrial Cancer</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Icahn School of Medicine at Mount Sinai</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Icahn School of Medicine at Mount Sinai</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        This is an open-label, Phase 1 study with a dose expansion cohort of Sacituzumab Govitecan in&#xD;
        Combination with Cisplatin in Platinum Sensitive Recurrent Ovarian and Endometrial Cancer.&#xD;
        The goal of the study is to determine the optimal dose of sacituzumab govitecan for use in&#xD;
        combination with cisplatin for treatment of epithelial ovarian and endometrial cancers.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is an open-label, Phase 1 study with a dose expansion cohort, conducted in two separate&#xD;
        disease groups (ovarian and endometrial cancer). The primary objective of the study is to&#xD;
        determine the optimal dose of sacituzumab govitecan for use in combination with cisplatin for&#xD;
        treatment of epithelial ovarian and endometrial cancers.&#xD;
  &#xD;
        For each disease group, there will be a safety run-in phase utilizing a 3+3 design with a&#xD;
        de-escalated dose level if the starting dose shows toxicity and an expansion cohort to&#xD;
        evaluate the preliminary efficacy and tolerability of the experimental regimen. The dose&#xD;
        expansion cohort will consist of 14 patients in the ovarian cohort and 12 patients in the&#xD;
        endometrial cohort with an additional 2 patients in each cohort to account for potential&#xD;
        patient replacement. This will yield a total sample size of 22-28 patients in the ovarian&#xD;
        cancer cohort and a total sample size of 20-26 patients in the endometrial cancer cohort.&#xD;
  &#xD;
        Phase 1, Safety Run-in with Dose De-escalation Scheme:&#xD;
  &#xD;
        Dose Level 0, starting level: Sacituzumab govitecan 10 mg/kg + Cisplatin 70 mg/m2 IV Dose -1:&#xD;
        Sacituzumab govitecan 7.5 mg/kg + Cisplatin 70 mg/m2 IV In this stage, a minimum of 6&#xD;
        patients and a maximum of 12 patients will be required.&#xD;
  &#xD;
        The recommended dose expansion cohort (DEC) dose is defined as the highest dose at which no&#xD;
        more than 1 out of 6 patients experience a Dose-Limiting Toxicity (DLT)&#xD;
  &#xD;
        Phase 2, Dose Expansion Cohort:&#xD;
  &#xD;
        Sacituzumab govitecan 7.5-10 mg/kg IV (depending on phase I result) + Cisplatin 70 mg/m2 IV.&#xD;
  &#xD;
        Drug product administration will continue until PD, unacceptable toxicity, or death.&#xD;
  &#xD;
        The DEC is designed to indicate proof of concept regarding the overall response rate (ORR)&#xD;
        and safety of the combination of sacituzumab with cisplatin at the dose established in the&#xD;
        safety run-in phase of the study. Once the recommended DEC dose for sacituzumab and cisplatin&#xD;
        combination has been established for each disease cohort, an additional 14 patients will be&#xD;
        enrolled for the ovarian group and and 12 patients for the endometrial group. An additional 2&#xD;
        patients will be added to each cohort to account for potential patient replacement for a&#xD;
        total of 42-54 evaluable patients.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 7, 2023</start_date>
    <completion_date type="Anticipated">September 7, 2026</completion_date>
    <primary_completion_date type="Anticipated">September 7, 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>Non-Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Dose-limiting toxicity (DLT) for the Safety Run-In Phase</measure>
      <time_frame>within the first cycle of therapy (each cycle = 21 days)</time_frame>
      <description>Safety Run-In Phase: Dose-limiting toxicity (DLT) and the recommended Dose Expansion Cohort (DEC) dose of sacituzumab govitecan in combination with a fixed schedule of cisplatin in patients with ovarian and endometrial cancers.&#xD;
  DLT is defined as any therapy-attributable adverse event (AE) requiring discontinuation of therapy within one cycle of combined therapy; specifically grade 3 or 4 non-hematologic toxicity and grade 4 hematologic toxicity events. These will be assessed via NCI's CTCAE v 5.0 toxicity criteria. DEC dose is defined as the highest dose at which no more than 1 out of 6 patients experience a DLT.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Dose limiting toxicity (DLT) for the DEC Phase</measure>
      <time_frame>within 1 cycle of therapy (each cycle = 21 days)</time_frame>
      <description>Dose Expansion Cohort Phase: DLT is defined as any therapy-attributable adverse event (AE) requiring discontinuation of therapy within one cycle of combined therapy; specifically grade 3 or 4 non-hematologic toxicity and grade 4 hematologic toxicity events. These will be assessed via NCI's CTCAE v 5.0 toxicity criteria. The DLT rate for the DEC cohort is define as the proportion of patients in the safety population and DEC phase of the study that experience at least 1 DLT within the first cycle of sacituzumab in combination with cisplatin treated at the maximum tolerated dose (MTD)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Overall Response Rate (ORR)</measure>
      <time_frame>every 3 cycles (each cycle is 21 days)</time_frame>
      <description>Overall Response Rate&#xD;
  ORR will be measured by the percentage of patients whose cancer decreases in size on assessment. This will be measured as the sum of complete response and partial response by RECISIT 1.1 criteria.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Clinical Benefit Response (CBR)</measure>
      <time_frame>6 months</time_frame>
      <description>CBR will be measured by the percentage of patients whose cancer shrinks or remains stable over the duration of the study. This will be measured as the sum of complete response (CR), partial response (PR), and stable disease (SD) for greater than or equal to 6 months.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Progression free survival (PFS)</measure>
      <time_frame>6 months</time_frame>
      <description>6 month progression free survival (PFS) as defined as the time from the start of treatment until confirmed disease progression or death from any cause, whichever occurs first. Disease status (i.e., SD, PR, PR, CR or progressive disease (PD)) will be assessed based on RECIST 1.1 criteria for measurable and non-measurable disease.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">54</enrollment>
    <condition>Ovarian Cancer</condition>
    <condition>Malignant Neoplasm of Uterus</condition>
    <arm_group>
      <arm_group_label>ovarian cancer arm</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>DEC 3+3 dose expansion of Sacituzumab Govitecan in Combination with Cisplatin</description>
    </arm_group>
    <arm_group>
      <arm_group_label>endometrial cancer arm</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>DEC 3+3 dose expansion of Sacituzumab Govitecan in Combination with Cisplatin</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Sacituzumab</intervention_name>
      <description>Dose 0: Sacituzumab govitecan 10 mg/kg&#xD;
  Dose 1: Sacituzumab govitecan 7.5 mg/kg</description>
      <arm_group_label>endometrial cancer arm</arm_group_label>
      <arm_group_label>ovarian cancer arm</arm_group_label>
      <other_name>Sacituzumab Govitecan</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Cisplatin</intervention_name>
      <description>Cisplatin 70 mg/m2 IV</description>
      <arm_group_label>endometrial cancer arm</arm_group_label>
      <arm_group_label>ovarian cancer arm</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          * must provide value Expand Pathologic (histology or cytology) confirmed diagnosis of&#xD;
          epithelial ovarian cancer or endometrial cancer Radiographic evidence of recurrent&#xD;
          epithelial ovarian cancer (ovarian, fallopian tube, or primary peritoneal cancer) or&#xD;
          endometrial cancer that is &quot;platinum-sensitive,&quot; defined as progression of disease beyond 6&#xD;
          months from the last dose of platinum-based chemotherapy Female, age ≥ 18 years World&#xD;
          Health Organization (WHO) performance status 0-1 with no deterioration over the previous 2&#xD;
          weeks and minimum life expectancy of 12 weeks Patient has measurable disease (at least one&#xD;
          lesion that can be accurately assessed repeatedly by CT) as evidenced on pre-treatment&#xD;
          baseline CT of Chest/Abdomen/Pelvis or PET/CT, or evaluable disease&#xD;
  &#xD;
          Adequate hematologic counts, as defined below. without transfusion or growth factor support&#xD;
          within 2 weeks of study drug initiation:&#xD;
  &#xD;
            -  Hemoglobin ≥ 8 g/dL&#xD;
  &#xD;
            -  Absolute neutrophil count ≥ 1500/mm3&#xD;
  &#xD;
            -  Platelets ≥ 100,000/μL&#xD;
  &#xD;
          Adequate organ function as defined below:&#xD;
  &#xD;
            -  Total bilirubin ≤ 1.5 ULN&#xD;
  &#xD;
            -  AST(SGOT)/ALT(SPGT) ≤ 2.5x ULN or ≤ 5 x ULN if known liver metastases&#xD;
  &#xD;
            -  Serum albumin &gt; 3 g/dL&#xD;
  &#xD;
            -  Creatinine clearance ≥ 50 mL/min per the Cockcroft-Gault equation&#xD;
  &#xD;
          Women of child-bearing potential must agree to use adequate contraception prior to study&#xD;
          entry, for the duration of study participation, and for 90 days following completion of&#xD;
          therapy. Should a woman become pregnant or suspect she is pregnant while participating in&#xD;
          this study, she should inform her treating physician immediately.&#xD;
  &#xD;
          A female of child-bearing potential is any woman (regardless of sexual orientation, having&#xD;
          undergone a tubal ligation, or remaining celibate by choice) who meets the following&#xD;
          criteria:&#xD;
  &#xD;
            -  Has not undergone a hysterectomy or bilateral oophorectomy; or&#xD;
  &#xD;
            -  Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has&#xD;
               had menses at any time in the preceding 12 consecutive months).&#xD;
  &#xD;
          Ability to understand and the willingness to sign a written informed consent.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Treatment with any of the following:&#xD;
  &#xD;
            -  Any investigational agents or study drugs from a previous clinical study within 28&#xD;
               days of the first dose of study treatment&#xD;
  &#xD;
            -  Any other chemotherapy, immunotherapy or anticancer agents within 14 days of the first&#xD;
               dose of study treatment&#xD;
  &#xD;
            -  Major surgery (excluding placement of vascular access) within 4 weeks of the first&#xD;
               dose of study treatment&#xD;
  &#xD;
            -  Radiotherapy with a wide field of radiation within 4 weeks or radiotherapy with a&#xD;
               limited field of radiation for palliation within 2 weeks of the first dose of study&#xD;
               treatment&#xD;
  &#xD;
            -  With the exception of alopecia, any unresolved toxicities from prior therapy greater&#xD;
               than Common Terminology Criteria for Adverse Events (CTCAE) grade 1 at the time of&#xD;
               starting study treatment&#xD;
  &#xD;
            -  As judged by the investigator, any evidence of severe or uncontrolled systemic&#xD;
               diseases, including active bleeding diatheses, or uncontrolled infection including&#xD;
               hepatitis B, hepatitis C and human immunodeficiency virus (HIV). Screening for chronic&#xD;
               conditions is not required.&#xD;
  &#xD;
            -  History of allergic reactions attributed to compounds of similar chemical or biologic&#xD;
               composition to sacituzumab govitecan, cisplatin or irinotecan.&#xD;
  &#xD;
            -  Peripheral neuropathy grade 2 or greater&#xD;
  &#xD;
            -  Refractory nausea and vomiting, chronic gastrointestinal diseases&#xD;
  &#xD;
            -  Patients must not be pregnant or nursing due to the potential for congenital&#xD;
               abnormalities and the potential of this regimen to harm nursing infants.&#xD;
  &#xD;
            -  Women of childbearing potential unwilling to use effective contraception during study&#xD;
               until conclusion of 4-week post-treatment evaluation period&#xD;
  &#xD;
            -  Known history of unstable angina, MI, or CHF present within 6 months of randomization&#xD;
               or clinically significant cardiac arrhythmia (other than stable atrial fibrillation)&#xD;
               requiring anti-arrhythmia therapy&#xD;
  &#xD;
            -  Known history of clinically significant active COPD, or other moderate-to-severe&#xD;
               chronic respiratory illness present within 6 months of enrollment.&#xD;
  &#xD;
            -  Prior history of clinically significant bleeding, intestinal obstruction, or GI&#xD;
               perforation within 6 months of enrollment.&#xD;
  &#xD;
            -  Other concurrent medical or psychiatric conditions that, in the Investigator's&#xD;
               opinion, may be likely to confound study interpretation or prevent completion of study&#xD;
               procedures and follow-up examinations.&#xD;
  &#xD;
            -  Prior therapy with sacituzumab govitecan, irinotecan, or any topoisomerase&#xD;
               I-containing antibody-drug conjugates at any time for early stage disease&#xD;
  &#xD;
            -  Have active chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease)&#xD;
               or GI perforation within 6 months of enrollment.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <gender_description>Female</gender_description>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Amy Tiersten, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Icahn School of Medicine at Mount Sinai Division of Hematology and Medical Oncology</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Amy Tiersten, MD</last_name>
      <phone>(212) 241-3300</phone>
      <email>amy.tiersten@mssm.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Melanie Kier, MD</last_name>
      <email>melanie.kier@mssm.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Icahn School of Medicine at Mount Sinai Division of Hematology and Medical Oncology</name>
        <address>
          <city>New York</city>
          <state>New York</state>
          <zip>10029</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Amy Tiersten, MD</last_name>
        <phone>212-241-3300</phone>
        <email>amy.tiersten@mssm.edu</email>
      </contact>
      <contact_backup>
        <last_name>Melanie Kier, MD</last_name>
        <email>melanie.kier@mssm.edu</email>
      </contact_backup>
      <investigator>
        <last_name>Amy Tiersten</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 5, 2023</study_first_submitted>
    <study_first_submitted_qc>September 14, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 18, 2023</study_first_posted>
    <last_update_submitted>September 14, 2023</last_update_submitted>
    <last_update_submitted_qc>September 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Icahn School of Medicine at Mount Sinai</investigator_affiliation>
      <investigator_full_name>Amy Tiersten</investigator_full_name>
      <investigator_title>MD. Professor of Medicine (Hematology and Medical Oncology) Clinical Director, Breast Medical Oncology, Dubin Breast Center</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Endometrial Neoplasms</mesh_term>
      <mesh_term>Neoplasms</mesh_term>
      <mesh_term>Uterine Neoplasms</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Sacituzumab govitecan</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>There are no plans to share individual participant data, supporting information, or biological samples that are collected as part of this study for future research, even if the participant's identity is removed. Data and samples will only be used to complete this study. If the results of this study are presented or reported in a publication, the participants will not be identified. All results will be kept confidential and will not be divulged without permission, except as required by law.</ipd_description>
    </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/NCT06040970
  org study id: STUDY-22-00832
  nct id: NCT06040970
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: Yes
  This is an open-label, Phase 1 study with a dose expansion cohort of Sacituzumab Govitecan in
        Combination with Cisplatin in Platinum Sensitive Recurrent Ovarian and Endometrial Cancer.
        The goal of the study is to determine the optimal dose of sacituzumab govitecan for use in
        combination with cisplatin for treatment of epithelial ovarian and endometrial cancers.
  This is an open-label, Phase 1 study with a dose expansion cohort, conducted in two separate
        disease groups (ovarian and endometrial cancer). The primary objective of the study is to
        determine the optimal dose of sacituzumab govitecan for use in combination with cisplatin for
        treatment of epithelial ovarian and endometrial cancers.
  
        For each disease group, there will be a safety run-in phase utilizing a 3+3 design with a
        de-escalated dose level if the starting dose shows toxicity and an expansion cohort to
        evaluate the preliminary efficacy and tolerability of the experimental regimen. The dose
        expansion cohort will consist of 14 patients in the ovarian cohort and 12 patients in the
        endometrial cohort with an additional 2 patients in each cohort to account for potential
        patient replacement. This will yield a total sample size of 22-28 patients in the ovarian
        cancer cohort and a total sample size of 20-26 patients in the endometrial cancer cohort.
  
        Phase 1, Safety Run-in with Dose De-escalation Scheme:
  
        Dose Level 0, starting level: Sacituzumab govitecan 10 mg/kg + Cisplatin 70 mg/m2 IV Dose -1:
        Sacituzumab govitecan 7.5 mg/kg + Cisplatin 70 mg/m2 IV In this stage, a minimum of 6
        patients and a maximum of 12 patients will be required.
  
        The recommended dose expansion cohort (DEC) dose is defined as the highest dose at which no
        more than 1 out of 6 patients experience a Dose-Limiting Toxicity (DLT)
  
        Phase 2, Dose Expansion Cohort:
  
        Sacituzumab govitecan 7.5-10 mg/kg IV (depending on phase I result) + Cisplatin 70 mg/m2 IV.
  
        Drug product administration will continue until PD, unacceptable toxicity, or death.
  
        The DEC is designed to indicate proof of concept regarding the overall response rate (ORR)
        and safety of the combination of sacituzumab with cisplatin at the dose established in the
        safety run-in phase of the study. Once the recommended DEC dose for sacituzumab and cisplatin
        combination has been established for each disease cohort, an additional 14 patients will be
        enrolled for the ovarian group and and 12 patients for the endometrial group. An additional 2
        patients will be added to each cohort to account for potential patient replacement for a
        total of 42-54 evaluable patients.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Dose-limiting toxicity (DLT) for the Safety Run-In Phase
  time frame: within the first cycle of therapy (each cycle = 21 days)
  description: Safety Run-In Phase: Dose-limiting toxicity (DLT) and the recommended Dose Expansion Cohort (DEC) dose of sacituzumab govitecan in combination with a fixed schedule of cisplatin in patients with ovarian and endometrial cancers.
  DLT is defined as any therapy-attributable adverse event (AE) requiring discontinuation of therapy within one cycle of combined therapy; specifically grade 3 or 4 non-hematologic toxicity and grade 4 hematologic toxicity events. These will be assessed via NCI's CTCAE v 5.0 toxicity criteria. DEC dose is defined as the highest dose at which no more than 1 out of 6 patients experience a DLT.
  measure: Dose limiting toxicity (DLT) for the DEC Phase
  time frame: within 1 cycle of therapy (each cycle = 21 days)
  description: Dose Expansion Cohort Phase: DLT is defined as any therapy-attributable adverse event (AE) requiring discontinuation of therapy within one cycle of combined therapy; specifically grade 3 or 4 non-hematologic toxicity and grade 4 hematologic toxicity events. These will be assessed via NCI's CTCAE v 5.0 toxicity criteria. The DLT rate for the DEC cohort is define as the proportion of patients in the safety population and DEC phase of the study that experience at least 1 DLT within the first cycle of sacituzumab in combination with cisplatin treated at the maximum tolerated dose (MTD)
  measure: Overall Response Rate (ORR)
  time frame: every 3 cycles (each cycle is 21 days)
  description: Overall Response Rate
  ORR will be measured by the percentage of patients whose cancer decreases in size on assessment. This will be measured as the sum of complete response and partial response by RECISIT 1.1 criteria.
  measure: Clinical Benefit Response (CBR)
  time frame: 6 months
  description: CBR will be measured by the percentage of patients whose cancer shrinks or remains stable over the duration of the study. This will be measured as the sum of complete response (CR), partial response (PR), and stable disease (SD) for greater than or equal to 6 months.
  measure: Progression free survival (PFS)
  time frame: 6 months
  description: 6 month progression free survival (PFS) as defined as the time from the start of treatment until confirmed disease progression or death from any cause, whichever occurs first. Disease status (i.e., SD, PR, PR, CR or progressive disease (PD)) will be assessed based on RECIST 1.1 criteria for measurable and non-measurable disease.
  arm group label: ovarian cancer arm
  arm group type: Experimental
  description: DEC 3+3 dose expansion of Sacituzumab Govitecan in Combination with Cisplatin
  arm group label: endometrial cancer arm
  arm group type: Experimental
  description: DEC 3+3 dose expansion of Sacituzumab Govitecan in Combination with Cisplatin
  intervention type: Drug
  intervention name: Sacituzumab
  description: Dose 0: Sacituzumab govitecan 10 mg/kg
  Dose 1: Sacituzumab govitecan 7.5 mg/kg
  arm group label: endometrial cancer arm
  arm group label: ovarian cancer arm
  other name: Sacituzumab Govitecan
  intervention type: Drug
  intervention name: Cisplatin
  description: Cisplatin 70 mg/m2 IV
  arm group label: endometrial cancer arm
  arm group label: ovarian cancer arm
  criteria: 
  gender: Female
  gender based: Yes
  gender description: Female
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Amy Tiersten, MD
  role: Principal Investigator
  affiliation: Icahn School of Medicine at Mount Sinai Division of Hematology and Medical Oncology
  last name: Amy Tiersten, MD
  phone: (212) 241-3300
  email: amy.tiersten@mssm.edu
  last name: Melanie Kier, MD
  email: melanie.kier@mssm.edu
  facility: 
  contact: 
  contact backup: 
  investigator: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: Icahn School of Medicine at Mount Sinai
  investigator full name: Amy Tiersten
  investigator title: MD. Professor of Medicine (Hematology and Medical Oncology) Clinical Director, Breast Medical Oncology, Dubin Breast Center
  mesh term: Endometrial Neoplasms
  mesh term: Neoplasms
  mesh term: Uterine Neoplasms
  mesh term: Sacituzumab govitecan
  sharing ipd: No
  ipd description: There are no plans to share individual participant data, supporting information, or biological samples that are collected as part of this study for future research, even if the participant's identity is removed. Data and samples will only be used to complete this study. If the results of this study are presented or reported in a publication, the participants will not be identified. All results will be kept confidential and will not be divulged without permission, except as required by law.