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/NCT06028932</url>
    </required_header>
    <id_info>
      <org_study_id>2000036114</org_study_id>
      <nct_id>NCT06028932</nct_id>
    </id_info>
    <brief_title>A Study of Sacituzumab Govitecan (IMMU-132) in Platinum-resistant Ovarian Cancer Patients</brief_title>
    <official_title>A Phase II Evaluation of Sacituzumab Govitecan (IMMU-132), an Anti-Trop-2-SN-38 Antibody-drug Conjugate in Recurrent or Persistent Platinum-resistant Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancers</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Alessandro Santin</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Gilead Sciences</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>Yale University</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>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        This is a non-randomized Phase 2 study of sacituzumab govitecan (IMMU-132) in subjects with&#xD;
        recurrent or persistent platinum-resistant epithelial ovarian, fallopian tube, or primary&#xD;
        peritoneal cancers.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is an open-label, Phase 2 study designed to assess the clinical activity of sacituzumab&#xD;
        govitecan in subjects with recurrent or persistent platinum-resistant epithelial ovarian,&#xD;
        fallopian tube, or primary peritoneal cancers.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">November 1, 2023</start_date>
    <completion_date type="Anticipated">November 1, 2027</completion_date>
    <primary_completion_date type="Anticipated">November 1, 2025</primary_completion_date>
    <phase>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>Objective Response Rate (ORR)</measure>
      <time_frame>4 Years</time_frame>
      <description>Objective response rate (complete response and partial response rates) by RECIST1.1 criteria in patients with platinum resistant recurrent ovarian carcinoma.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Duration of overall survival (OS)</measure>
      <time_frame>6 Years</time_frame>
      <description>Overall survival is defined as the duration of time from study entry to death or the date of last contact.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Duration of progression free survival (PFS)</measure>
      <time_frame>6 Years</time_frame>
      <description>Progression free survival is defined as the duration of time from study entry to time of progression, death, or is censored at date of last disease assessment</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Durable disease control rate (DDCR)</measure>
      <time_frame>6 Years</time_frame>
      <description>The percentage of patients who have achieved complete response, partial response, and stable disease.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Assess the safety profile of sacituzumab govitecan in ovarian cancer patients (adverse events as assessed by CTCAE v5.0)</measure>
      <time_frame>6 Years</time_frame>
      <description>Incidence of treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">20</enrollment>
    <condition>Ovarian Carcinoma</condition>
    <arm_group>
      <arm_group_label>Sacituzumab govitecan, 10 mg/kg</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Sacituzumab govitecan, 10 mg/kg for the first 2 weeks of 21-day cycle until progression or adverse effects prohibit further treatment</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Sacituzumab govitecan</intervention_name>
      <description>Sacituzumab govitecan will be administered at 10 mg/kg weekly as an infusion for 2 consecutive weeks (2 weekly doses plus 1 week without treatment represents a single 3 week cycle). Treatment can be continued without a rest period in the absence of progression of disease or unacceptable toxicity.</description>
      <arm_group_label>Sacituzumab govitecan, 10 mg/kg</arm_group_label>
      <other_name>IMMU-132</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients must have platinum-resistant (i.e., platinum-free interval &lt;6 months)&#xD;
               recurrent or persistent histologically confirmed epithelial (non-mucinous) ovarian,&#xD;
               fallopian tube, or primary peritoneal cancer. Patients may have serous, endometrioid,&#xD;
               clear cell, (pure or mixed), or undifferentiated histology.&#xD;
  &#xD;
                 -  Must have availability of archival tumor tissue FFPE block for TROP-2 testing&#xD;
  &#xD;
            -  All patients must have measurable disease. Measurable disease is defined as lesions&#xD;
               which can be measured by physical examination or by means of medical imaging&#xD;
               techniques. Measurable disease is defined as at least one lesion that can be&#xD;
               accurately measured in at least one dimension (longest dimension to be recorded). Each&#xD;
               lesion must be ≥ 20 mm when measured by conventional techniques, including palpation&#xD;
               or plain x-ray, or ≥ 10 mm when measured by spiral CT and/or MRI. Ascites and pleural&#xD;
               effusions are not to be considered measurable disease.&#xD;
  &#xD;
            -  Patients must have at least one &quot;target lesion&quot; to be used to assess response on this&#xD;
               protocol as defined by RECIST v1.1. Tumors within a previously irradiated field will&#xD;
               be designated as &quot;non-target&quot; lesions unless progression is documented, or a biopsy is&#xD;
               obtained to confirm persistence following completion of radiation therapy.&#xD;
  &#xD;
            -  After undergoing surgery, patients may be optimally or sub optimally debulked.&#xD;
  &#xD;
            -  Patients with measurable recurrent disease of any previous substage (I-IV) are&#xD;
               eligible to enrollment.&#xD;
  &#xD;
            -  Patients must have adequate bone marrow function: WBC greater than or equal to&#xD;
               3,000/ul, Platelets greater than or equal to 75,000/ul, Neutrophils greater than or&#xD;
               equal to 1500/ul.&#xD;
  &#xD;
            -  Patients must have adequate renal function: creatinine less than or equal to 2.0&#xD;
               mg/dL.&#xD;
  &#xD;
            -  Patients must have adequate hepatic function: bilirubin ≤ 1.5 institutional upper&#xD;
               limit of normal, aspartate aminotransferase [AST], and alanine aminotransferase [ALT]&#xD;
               ≤ 2.5 × IULN or ≤ 5 × IULN if known liver metastases&#xD;
  &#xD;
            -  Patients must have an ECOG performance status of 0 or 1.&#xD;
  &#xD;
            -  Patients must have signed an approved informed consent.&#xD;
  &#xD;
            -  Patients must be at least 2 weeks beyond prior treatment (chemotherapy,&#xD;
               investigational drugs including small molecular inhibitors, endocrine therapy,&#xD;
               immunotherapy and/or radiation therapy) or major surgery.&#xD;
  &#xD;
            -  Patients must be at least 2 weeks beyond high dose systemic corticosteroids (however,&#xD;
               low dose corticosteroids &lt;20 mg prednisone or equivalent daily are permitted)&#xD;
  &#xD;
            -  Patients must have recovered from all acute toxicities to Grade 1 or less from adverse&#xD;
               events due to a previously administered agent&#xD;
  &#xD;
                 -  Note: Patients with ≤ Grade 2 neuropathy or ≤ Grade 2 alopecia are an exception&#xD;
                    to this criterion and may qualify for the study&#xD;
  &#xD;
                 -  Note: If patients received major surgery, they must have recovered adequately&#xD;
                    from the toxicity and/or complications from the intervention prior to starting&#xD;
                    therapy&#xD;
  &#xD;
            -  Patients with recurrent disease may have received no more than 2 prior chemotherapies&#xD;
               for treatment of the recurrent ovarian cancer.&#xD;
  &#xD;
                 -  Adjuvant ± neoadjuvant are considered one line of therapy&#xD;
  &#xD;
                 -  Maintenance therapy (eg, bevacizumab, PARP inhibitors) are considered as part of&#xD;
                    the preceding line of therapy (ie, not counted independently).&#xD;
  &#xD;
                 -  Therapy changed due to toxicity or allergy in the absence of progression will be&#xD;
                    considered as part of the same line (ie, not counted independently).&#xD;
  &#xD;
            -  Patients may have received prior immunotherapy therapy alone or in combination with&#xD;
               chemotherapy. A 4-week washout period is required between prior immunotherapy&#xD;
               treatment and first dose of sacituzumab govitecan.&#xD;
  &#xD;
            -  Patients of childbearing potential must have a negative serum pregnancy test within 7&#xD;
               days prior to the study entry and must agree to use protocol-specific method(s) of&#xD;
               contraception. .&#xD;
  &#xD;
            -  Patients must be at least 18 years of age.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with a positive serum pregnancy test or women who are breastfeeding.&#xD;
  &#xD;
            -  Patients with known hypersensitivity to the study drug, its metabolites, or&#xD;
               formulation excipient.&#xD;
  &#xD;
            -  Patients who require ongoing therapy with or prior use of any prohibited medication(s)&#xD;
               such as UGT1A1 inhibitors.&#xD;
  &#xD;
            -  Have 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;
            -  Any medical condition that, in the investigator's or sponsor's opinion, poses an undue&#xD;
               risk to the patient's participation in the study.&#xD;
  &#xD;
            -  Patients with a history of other invasive malignancies, with the exception of&#xD;
               non-melanoma skin cancers or carcinoma in situ of the cervix, are excluded if there is&#xD;
               any evidence of other malignancy being present within the last 5 years.&#xD;
  &#xD;
            -  Patients with a significant history of cardiac disease within 6 months, i.e.,&#xD;
               uncontrolled hypertension, unstable angina, uncontrolled congestive heart failure&#xD;
               (NYHA classification III-IV) or clinically significant cardiac arrhythmia (other than&#xD;
               stable atrial fibrillation) requiring antiarrhythmia therapy.&#xD;
  &#xD;
            -  Patients with known history of clinically significant active COPD, or other&#xD;
               moderate-to-severe chronic respiratory illness present within 6 months&#xD;
  &#xD;
            -  Patients with any unstable medical issue (including cardiac issues as above, active&#xD;
               treatment for symptomatic pulmonary embolism, CVA, renal or hepatic insufficiency, and&#xD;
               active infection/sepsis requiring IV antibiotics).&#xD;
  &#xD;
            -  Have known active CNS metastases and/or carcinomatous meningitis. Patients with&#xD;
               previously treated brain metastases may participate provided they have stable CNS&#xD;
               disease for at least 4 weeks prior to the first dose of study drug and all neurologic&#xD;
               symptoms have returned to baseline, have no evidence of new or enlarging brain&#xD;
               metastases, and are taking ≤20 mg/day of prednisone or its equivalent. All patients&#xD;
               with carcinomatous meningitis are excluded regardless of clinical stability&#xD;
  &#xD;
            -  Patients who have an uncontrolled seizure disorder, or active neurological disease.&#xD;
  &#xD;
            -  Have known history of HIV-1 or 2 (or positive HIV-1/2 antibody) with detectable viral&#xD;
               load OR taking medications that may interfere with SN-38 metabolism&#xD;
  &#xD;
            -  Have active HBV or HCV. In subjects with a history of HBV or HCV, subjects with a&#xD;
               detectable viral load will be excluded.&#xD;
  &#xD;
            -  Known hemorrhagic diathesis or active bleeding disorder.&#xD;
  &#xD;
            -  Patients with Gilbert's disease&#xD;
  &#xD;
            -  Presence of bulky disease (defined as any single mass &gt;7 cm in its greatest&#xD;
               dimension). Patients with a mass over 7 cm, but otherwise eligible, may be considered&#xD;
               for enrollment after discussion and approval with the study PI.&#xD;
  &#xD;
            -  Patients with active ≥ grade 2 anorexia, nausea or vomiting, and/or signs of&#xD;
               intestinal obstruction.&#xD;
  &#xD;
            -  Prior history of clinically significant bleeding, intestinal obstruction, or GI&#xD;
               perforation within 6 months of initiation of study treatment.&#xD;
  &#xD;
            -  Patients with a history of an anaphylactic reaction to irinotecan or ≥ Grade 3 GI&#xD;
               toxicity to prior irinotecan.&#xD;
  &#xD;
            -  Have previously received topoisomerase I inhibitors&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Alessandro Santin, M.D.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Yale University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Alessandro Santin, M.D.</last_name>
      <phone>203-737-4450</phone>
      <email>alessandro.santin@yale.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Lisa Baker, R.N.</last_name>
      <phone>203-785-6398</phone>
      <email>lisa.baker@yale.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Smilow Cancer Hospital at Yale New Haven</name>
        <address>
          <city>New Haven</city>
          <state>Connecticut</state>
          <zip>06510</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Lisa Baker, R.N.</last_name>
        <phone>203-785-6398</phone>
        <email>lisa.baker@yale.edu</email>
      </contact>
      <contact_backup>
        <last_name>Amy Nicoletti, M.S.</last_name>
        <phone>2037852497</phone>
        <email>amy.nicoletti@yale.edu</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 31, 2023</study_first_submitted>
    <study_first_submitted_qc>August 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 8, 2023</study_first_posted>
    <last_update_submitted>August 31, 2023</last_update_submitted>
    <last_update_submitted_qc>August 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Yale University</investigator_affiliation>
      <investigator_full_name>Alessandro Santin</investigator_full_name>
      <investigator_title>Professor of Obstetrics, Gynecology, and Reproductive Sciences</investigator_title>
    </responsible_party>
    <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>
    </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>
    </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/NCT06028932
  org study id: 2000036114
  nct id: NCT06028932
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: No
  This is a non-randomized Phase 2 study of sacituzumab govitecan (IMMU-132) in subjects with
        recurrent or persistent platinum-resistant epithelial ovarian, fallopian tube, or primary
        peritoneal cancers.
  This is an open-label, Phase 2 study designed to assess the clinical activity of sacituzumab
        govitecan in subjects with recurrent or persistent platinum-resistant epithelial ovarian,
        fallopian tube, or primary peritoneal cancers.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Objective Response Rate (ORR)
  time frame: 4 Years
  description: Objective response rate (complete response and partial response rates) by RECIST1.1 criteria in patients with platinum resistant recurrent ovarian carcinoma.
  measure: Duration of overall survival (OS)
  time frame: 6 Years
  description: Overall survival is defined as the duration of time from study entry to death or the date of last contact.
  measure: Duration of progression free survival (PFS)
  time frame: 6 Years
  description: Progression free survival is defined as the duration of time from study entry to time of progression, death, or is censored at date of last disease assessment
  measure: Durable disease control rate (DDCR)
  time frame: 6 Years
  description: The percentage of patients who have achieved complete response, partial response, and stable disease.
  measure: Assess the safety profile of sacituzumab govitecan in ovarian cancer patients (adverse events as assessed by CTCAE v5.0)
  time frame: 6 Years
  description: Incidence of treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
  arm group label: Sacituzumab govitecan, 10 mg/kg
  arm group type: Experimental
  description: Sacituzumab govitecan, 10 mg/kg for the first 2 weeks of 21-day cycle until progression or adverse effects prohibit further treatment
  intervention type: Drug
  intervention name: Sacituzumab govitecan
  description: Sacituzumab govitecan will be administered at 10 mg/kg weekly as an infusion for 2 consecutive weeks (2 weekly doses plus 1 week without treatment represents a single 3 week cycle). Treatment can be continued without a rest period in the absence of progression of disease or unacceptable toxicity.
  arm group label: Sacituzumab govitecan, 10 mg/kg
  other name: IMMU-132
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Alessandro Santin, M.D.
  role: Principal Investigator
  affiliation: Yale University
  last name: Alessandro Santin, M.D.
  phone: 203-737-4450
  email: alessandro.santin@yale.edu
  last name: Lisa Baker, R.N.
  phone: 203-785-6398
  email: lisa.baker@yale.edu
  facility: 
  contact: 
  contact backup: 
  country: United States
  responsible party type: Sponsor-Investigator
  investigator affiliation: Yale University
  investigator full name: Alessandro Santin
  investigator title: Professor of Obstetrics, Gynecology, and Reproductive Sciences
  mesh term: Ovarian Neoplasms
  mesh term: Carcinoma, Ovarian Epithelial
  mesh term: Sacituzumab govitecan
  sharing ipd: No