<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/NCT03276572</url>
  </required_header>
  <id_info>
    <org_study_id>1706018281</org_study_id>
    <secondary_id>7R01CA207645-03</secondary_id>
    <nct_id>NCT03276572</nct_id>
  </id_info>
  <brief_title>Phase I Trial of 225Ac-J591 in Patients With mCRPC</brief_title>
  <official_title>Phase I Dose-Escalation Trial of 225Ac-J591 in Patients With Metastatic Castration-Resistant Prostate Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Weill Medical College of Cornell University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Prostate Cancer Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>United States Department of Defense</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institutes of Health (NIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Weill Medical College of Cornell 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>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is an open-label, single-center Phase I dose escalation study designed to determine the&#xD;
      dose-limiting toxicity (DLT) and the maximum tolerated dose (MTD) of 225Ac-J591 in a single&#xD;
      dose regimen.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This clinical trial is for men with advanced prostate cancer. The purpose of this study is to&#xD;
      find the highest dose level of the study drug, 225Ac-J591 that can be given without severe&#xD;
      side effects. The research study is being done because the standard treatments for prostate&#xD;
      cancer that has spread beyond the prostate gland are intended to minimize the adverse effects&#xD;
      of the disease. These treatments, however, are not curative. Patients who choose to&#xD;
      participate in this study will have a screening visit to determine whether or not they are&#xD;
      eligible to participate in the study. The treatment phase is comprised of 8 visits over&#xD;
      approximately 12 weeks. The study medication is called 225Ac-J591, and participants will&#xD;
      receive an infusion of the study drug on the Treatment visit of the study. Upon completion of&#xD;
      investigational treatment with single dose of 225Ac-J591, subjects will undergo&#xD;
      68Ga-PSMA-HBED-CC injection and same day PET/CT at the end of study visit to document&#xD;
      treatment response. Subsequently survival data and additional treatment(s) information will&#xD;
      be captured from their routine Standard of care (SOC) visits.During the other study visits,&#xD;
      participants will undergo routine tests and procedures, such as physical examinations, and&#xD;
      routine blood tests. Some blood tests will be done for research purposes only. After&#xD;
      completion of therapy, participants may be contacted on a periodic basis to see how they are&#xD;
      doing.&#xD;
&#xD;
      Key eligibility:&#xD;
&#xD;
        -  Open to men age 18 and older.&#xD;
&#xD;
        -  Diagnosis of progressive metastatic prostate cancer&#xD;
&#xD;
        -  Have been previously treated for their disease with particular types of therapy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">October 10, 2017</start_date>
  <completion_date type="Anticipated">July 2024</completion_date>
  <primary_completion_date type="Actual">January 7, 2021</primary_completion_date>
  <phase>Phase 1</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 Dose Limiting Toxicities (DLT)</measure>
    <time_frame>Assessed from start of treatment to up to 8 weeks after first study drug administration.</time_frame>
    <description>Count of participants will be measured by the recommended phase II dose in utilizing the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 for DLTs.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Subjects Who Reached Maximum Tolerated Dose (MTD)</measure>
    <time_frame>Assessed from start of treatment to up to 8 weeks after first study drug administration.</time_frame>
    <description>The MTD is the highest dose amongst the different dose-level cohorts in this study at which no more than 2 (33%) of the subjects in a cohort experience DLT.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects With Prostate Specific Antigen (PSA) Response</measure>
    <time_frame>PSA was assessed at screening, and up to 6 months after first treatment with study drug.</time_frame>
    <description>PSA will be analyzed through blood specimen collection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects With Circulating Tumor Cells (CTC) Response</measure>
    <time_frame>CTC was assessed at screening and 12 weeks after starting study drug.</time_frame>
    <description>CTCs will be analyzed through blood specimen collection via CellSearch methodology lab testing</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects With Radiographic (Imaging) Response</measure>
    <time_frame>Response were assessed for patients throughout their duration on the study, up to 3 years.</time_frame>
    <description>Radiographic response rate by Response evaluation criteria in solid tumors (RECIST) criteria with Prostate Cancer Working Group 3 (PCWG3) modifications</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression Free Survival (PFS)</measure>
    <time_frame>From the start of treatment to progression, up to 3 years</time_frame>
    <description>Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>All Subjects</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A single dose of 225Ac-J591 will be given to subjects with documented progressive metastatic CRPC.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>225Ac-J591</intervention_name>
    <description>225Ac-J591 (13.3 KBq/Kg - 93.3 KBq/Kg or 0.36 uCi/Kg - 2.52 uCi/Kg) on day 1</description>
    <arm_group_label>All Subjects</arm_group_label>
    <other_name>68Ga-PSMA-HBED-CC injection for PET/CT Scan on day 1 and at end of study</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Histologically or cytologically confirmed adenocarcinoma of prostate&#xD;
&#xD;
          2. Documented progressive metastatic CRPC based on Prostate Cancer Working Group 3&#xD;
             (PCWG3) criteria, which includes at least one of the following criteria:&#xD;
&#xD;
               1. PSA progression&#xD;
&#xD;
               2. Objective radiographic progression in soft tissue&#xD;
&#xD;
               3. New bone lesions&#xD;
&#xD;
          3. ECOG performance status of 0-2&#xD;
&#xD;
          4. Have serum testosterone &lt; 50 ng/dL. Subjects must continue primary androgen&#xD;
             deprivation with an LHRH analogue (agonist/antagonist) if they have not undergone&#xD;
             bilateral orchiectomy.&#xD;
&#xD;
          5. Have previously been treated with at least one of the following:&#xD;
&#xD;
               1. Androgen receptor signaling inhibitor (such as enzalutamide)&#xD;
&#xD;
               2. CYP 17 inhibitor (such as abiraterone acetate)&#xD;
&#xD;
          6. Have previously received taxane chemotherapy, been determined to be ineligible for&#xD;
             taxane chemotherapy by their physician, or refused taxane chemotherapy.&#xD;
&#xD;
          7. Age &gt; 18 years&#xD;
&#xD;
          8. Patients must have normal organ and marrow function as defined below:&#xD;
&#xD;
               1. Absolute neutrophil count &gt;2,000 cells/mm3&#xD;
&#xD;
               2. Hemoglobin ≥9 g/dL&#xD;
&#xD;
               3. Platelet count &gt;150,000 x 109/microliter&#xD;
&#xD;
               4. Serum creatinine &lt;1.5 x upper limit of normal (ULN) or calculated creatinine&#xD;
                  clearance ≥ 60 mL/min/1.73 m2 by Cockcroft-Gault&#xD;
&#xD;
               5. Serum total bilirubin &lt;1.5 x ULN (unless due to Gilbert's syndrome in which case&#xD;
                  direct bilirubin must be normal&#xD;
&#xD;
               6. Serum AST and ALT &lt;3 x ULN in absence of liver metastases; &lt;5x ULN if due to&#xD;
                  liver metastases (in both circumstances, bilirubin must meet entry criteria)&#xD;
&#xD;
          9. Ability to understand and the willingness to sign a written informed consent document.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Implantation of investigational medical device ≤4 weeks of Cycle 1, Day 1 or current&#xD;
             enrollment in oncologic investigational drug or device study&#xD;
&#xD;
          2. Use of investigational drugs ≤4 weeks or &lt;5 half-lives of Cycle 1, Day 1 or current&#xD;
             enrollment in investigational oncology drug or device study&#xD;
&#xD;
          3. Prior systemic beta-emitting bone-seeking radioisotopes&#xD;
&#xD;
          4. Known active brain metastases or leptomeningeal disease&#xD;
&#xD;
          5. History of deep vein thrombosis and/or pulmonary embolus within 1 month of C1D1&#xD;
&#xD;
          6. Other serious illness(es) involving the cardiac, respiratory, CNS, renal, hepatic or&#xD;
             hematological organ systems which might preclude completion of this study or interfere&#xD;
             with determination of causality of any adverse effects experienced in this study&#xD;
&#xD;
          7. Radiation therapy for treatment of PC ≤4 weeks of Day 1 Cycle 1&#xD;
&#xD;
          8. Patients on stable dose of bisphosphonates or Denosumab, which have been started no&#xD;
             less than 4 weeks prior to treatment start, may continue on this medication, however&#xD;
             patients are not allowed to initiate bisphosphonate/Denosumab therapy during the&#xD;
             DLT-assessment period of the study.&#xD;
&#xD;
          9. Having partners of childbearing potential and not willing to use a method of birth&#xD;
             control deemed acceptable by the principle investigator and chairperson during the&#xD;
             study and for 1 month after last study drug administration&#xD;
&#xD;
         10. Currently active other malignancy other than non-melanoma skin cancer. Patients are&#xD;
             considered not to have &quot;currently active&quot; malignancy if they have completed any&#xD;
             necessary therapy and are considered by their physician to be at less than 30% risk of&#xD;
             relapse.&#xD;
&#xD;
         11. Known history of known myelodysplastic syndrome&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Adult male patients of &gt;18 years age with documented progressive metastatic CRPC</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Scott Tagawa, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Weill Medical College of Cornell University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Tulane Cancer Center Clinic</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Weill Cornell Medical College</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>August 3, 2017</study_first_submitted>
  <study_first_submitted_qc>September 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 8, 2017</study_first_posted>
  <results_first_submitted>September 27, 2022</results_first_submitted>
  <results_first_submitted_qc>November 15, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">December 6, 2022</results_first_posted>
  <last_update_submitted>November 15, 2022</last_update_submitted>
  <last_update_submitted_qc>November 15, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 6, 2022</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>Prostatic Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gallium 68 PSMA-11</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>August 30, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/72/NCT03276572/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Recruitment took place at at Weill Cornell Medicine New York Presbyterian and Tulane Medical Center.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>225Ac-J591 Cohort 1</title>
          <description>Cohort 1: Participants were administered of 225Ac-J591 once at the dose level of 13.3 KBq/Kg - 0.36 Ci/Kg via intravenous infusion (IV). Participants were then followed until death for survival assessment</description>
        </group>
        <group group_id="P2">
          <title>225Ac-J591 Cohort 2</title>
          <description>Cohort 2: Participants were administered of 225Ac-J591 once at the dose level of 26.7 KBq/Kg - 0.72 Ci/Kg via intravenous infusion (IV). Participants were then followed until death for survival assessment.</description>
        </group>
        <group group_id="P3">
          <title>225Ac-J591 Cohort 3</title>
          <description>Cohort 3: Participants were administered of 225Ac-J591 once at the dose level of 40.0 KBq/Kg - 1.08 Ci/Kg via intravenous infusion (IV). Participants were then followed until death for survival assessment.</description>
        </group>
        <group group_id="P4">
          <title>225Ac-J591 Cohort 4</title>
          <description>Cohort 4: Participants were administered of 225Ac-J591 once at the dose level of 53.3 KBq/Kg - 1.44 Ci/Kg via intravenous infusion (IV). Participants were then followed until death for survival assessment.</description>
        </group>
        <group group_id="P5">
          <title>225Ac-J591 Cohort 5</title>
          <description>Cohort 5: Participants were administered of 225Ac-J591 once at the dose level of 66.7 KBq/Kg - 1.80 Ci/Kg via intravenous infusion (IV). Participants were then followed until death for survival assessment.</description>
        </group>
        <group group_id="P6">
          <title>225Ac-J591 Cohort 6</title>
          <description>Cohort 6: Participants were administered of 225Ac-J591 once at the dose level of 80.0 KBq/Kg - 2.16 Ci/Kg via intravenous infusion (IV). Participants were then followed until death for survival assessment.</description>
        </group>
        <group group_id="P7">
          <title>225Ac-J591 Cohort 7</title>
          <description>Cohort 7: Participants were administered of 225Ac-J591 once at the dose level of 93.3 KBq/Kg - 2.52 Ci/Kg via intravenous infusion (IV). Participants were then followed until death for survival assessment.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="6"/>
                <participants group_id="P6" count="6"/>
                <participants group_id="P7" count="16"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="6"/>
                <participants group_id="P6" count="5"/>
                <participants group_id="P7" count="14"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="1"/>
                <participants group_id="P7" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>In follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="1"/>
                <participants group_id="P7" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>225Ac-J591 Cohort 1</title>
          <description>Cohort 1: Participants were administered of 225Ac-J591 once at the dose level of 13.3 KBq/Kg - 0.36 Ci/Kg via intravenous infusion (IV). Participants were then followed until death for survival assessment</description>
        </group>
        <group group_id="B2">
          <title>225Ac-J591 Cohort 2</title>
          <description>Cohort 2: Participants were administered of 225Ac-J591 once at the dose level of 26.7 KBq/Kg - 0.72 Ci/Kg via intravenous infusion (IV). Participants were then followed until death for survival assessment.</description>
        </group>
        <group group_id="B3">
          <title>225Ac-J591 Cohort 3</title>
          <description>Cohort 3: Participants were administered of 225Ac-J591 once at the dose level of 40.0 KBq/Kg - 1.08 Ci/Kg via intravenous infusion (IV). Participants were then followed until death for survival assessment.</description>
        </group>
        <group group_id="B4">
          <title>225Ac-J591 Cohort 4</title>
          <description>Cohort 4: Participants were administered of 225Ac-J591 once at the dose level of 53.3 KBq/Kg - 1.44 Ci/Kg via intravenous infusion (IV). Participants were then followed until death for survival assessment.</description>
        </group>
        <group group_id="B5">
          <title>225Ac-J591 Cohort 5</title>
          <description>Cohort 5: Participants were administered of 225Ac-J591 once at the dose level of 66.7 KBq/Kg - 1.80 Ci/Kg via intravenous infusion (IV). Participants were then followed until death for survival assessment.</description>
        </group>
        <group group_id="B6">
          <title>225Ac-J591 Cohort 6</title>
          <description>Cohort 6: Participants were administered of 225Ac-J591 once at the dose level of 80.0 KBq/Kg - 2.16 Ci/Kg via intravenous infusion (IV). Participants were then followed until death for survival assessment.</description>
        </group>
        <group group_id="B7">
          <title>225Ac-J591 Cohort 7</title>
          <description>Cohort 7 with Expansion: Participants were administered of 225Ac-J591 once at the dose level of 93.3 KBq/Kg - 2.52 Ci/Kg via intravenous infusion (IV). Participants were then followed until death for survival assessment</description>
        </group>
        <group group_id="B8">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="1"/>
            <count group_id="B2" value="1"/>
            <count group_id="B3" value="1"/>
            <count group_id="B4" value="1"/>
            <count group_id="B5" value="6"/>
            <count group_id="B6" value="6"/>
            <count group_id="B7" value="16"/>
            <count group_id="B8" value="32"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="2"/>
                    <measurement group_id="B7" value="5"/>
                    <measurement group_id="B8" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="5"/>
                    <measurement group_id="B6" value="4"/>
                    <measurement group_id="B7" value="11"/>
                    <measurement group_id="B8" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="6"/>
                    <measurement group_id="B6" value="6"/>
                    <measurement group_id="B7" value="16"/>
                    <measurement group_id="B8" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="6"/>
                    <measurement group_id="B6" value="6"/>
                    <measurement group_id="B7" value="16"/>
                    <measurement group_id="B8" value="32"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="1"/>
                    <measurement group_id="B8" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="5"/>
                    <measurement group_id="B6" value="6"/>
                    <measurement group_id="B7" value="15"/>
                    <measurement group_id="B8" value="30"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Subjects With Dose Limiting Toxicities (DLT)</title>
        <description>Count of participants will be measured by the recommended phase II dose in utilizing the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 for DLTs.</description>
        <time_frame>Assessed from start of treatment to up to 8 weeks after first study drug administration.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>225Ac-J591 Cohort 1</title>
            <description>Cohort 1: Participants were administered of 225Ac-J591 once at the dose level of 13.3 KBq/Kg - 0.36 Ci/Kg via intravenous infusion (IV). Participants were then followed until death for survival assessment</description>
          </group>
          <group group_id="O2">
            <title>225Ac-J591 Cohort 2</title>
            <description>Cohort 2: Participants were administered of 225Ac-J591 once at the dose level of 26.7 KBq/Kg - 0.72 Ci/Kg via intravenous infusion (IV). Participants were then followed until death for survival assessment.</description>
          </group>
          <group group_id="O3">
            <title>225Ac-J591 Cohort 3</title>
            <description>Cohort 3: Participants were administered of 225Ac-J591 once at the dose level of 40.0 KBq/Kg - 1.08 Ci/Kg via intravenous infusion (IV). Participants were then followed until death for survival assessment.</description>
          </group>
          <group group_id="O4">
            <title>225Ac-J591 Cohort 4</title>
            <description>Cohort 4: Participants were administered of 225Ac-J591 once at the dose level of 53.3 KBq/Kg - 1.44 Ci/Kg via intravenous infusion (IV). Participants were then followed until death for survival assessment.</description>
          </group>
          <group group_id="O5">
            <title>225Ac-J591 Cohort 5</title>
            <description>Cohort 5: Participants were administered of 225Ac-J591 once at the dose level of 66.7 KBq/Kg - 1.80 Ci/Kg via intravenous infusion (IV). Participants were then followed until death for survival assessment.</description>
          </group>
          <group group_id="O6">
            <title>225Ac-J591 Cohort 6</title>
            <description>Cohort 6: Participants were administered of 225Ac-J591 once at the dose level of 80.0 KBq/Kg - 2.16 Ci/Kg via intravenous infusion (IV). Participants were then followed until death for survival assessment.</description>
          </group>
          <group group_id="O7">
            <title>225Ac-J591 Cohort 7</title>
            <description>Cohort 7: Participants were administered of 225Ac-J591 once at the dose level of 93.3 KBq/Kg - 2.52 Ci/Kg via intravenous infusion (IV). Participants were then followed until death for survival assessment.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects With Dose Limiting Toxicities (DLT)</title>
          <description>Count of participants will be measured by the recommended phase II dose in utilizing the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 for DLTs.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="1"/>
                <count group_id="O3" value="1"/>
                <count group_id="O4" value="1"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="6"/>
                <count group_id="O7" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="1"/>
                    <measurement group_id="O7" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Subjects Who Reached Maximum Tolerated Dose (MTD)</title>
        <description>The MTD is the highest dose amongst the different dose-level cohorts in this study at which no more than 2 (33%) of the subjects in a cohort experience DLT.</description>
        <time_frame>Assessed from start of treatment to up to 8 weeks after first study drug administration.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>225Ac-J591 Cohort 1</title>
            <description>Cohort 1: Participants were administered of 225Ac-J591 once at the dose level of 13.3 KBq/Kg - 0.36 Ci/Kg via intravenous infusion (IV). Participants were then followed until death for survival assessment</description>
          </group>
          <group group_id="O2">
            <title>225Ac-J591 Cohort 2</title>
            <description>Cohort 2: Participants were administered of 225Ac-J591 once at the dose level of 26.7 KBq/Kg - 0.72 Ci/Kg via intravenous infusion (IV). Participants were then followed until death for survival assessment.</description>
          </group>
          <group group_id="O3">
            <title>225Ac-J591 Cohort 3</title>
            <description>Cohort 3: Participants were administered of 225Ac-J591 once at the dose level of 40.0 KBq/Kg - 1.08 Ci/Kg via intravenous infusion (IV). Participants were then followed until death for survival assessment.</description>
          </group>
          <group group_id="O4">
            <title>225Ac-J591 Cohort 4</title>
            <description>Cohort 4: Participants were administered of 225Ac-J591 once at the dose level of 53.3 KBq/Kg - 1.44 Ci/Kg via intravenous infusion (IV). Participants were then followed until death for survival assessment.</description>
          </group>
          <group group_id="O5">
            <title>225Ac-J591 Cohort 5</title>
            <description>Cohort 5: Participants were administered of 225Ac-J591 once at the dose level of 66.7 KBq/Kg - 1.80 Ci/Kg via intravenous infusion (IV). Participants were then followed until death for survival assessment.</description>
          </group>
          <group group_id="O6">
            <title>225Ac-J591 Cohort 6</title>
            <description>Cohort 6: Participants were administered of 225Ac-J591 once at the dose level of 80.0 KBq/Kg - 2.16 Ci/Kg via intravenous infusion (IV). Participants were then followed until death for survival assessment.</description>
          </group>
          <group group_id="O7">
            <title>225Ac-J591 Cohort 7</title>
            <description>Cohort 7 with Expansion: Participants were administered of 225Ac-J591 once at the dose level of 93.3 KBq/Kg - 2.52 Ci/Kg via intravenous infusion (IV). Participants were then followed until death for survival assessment.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects Who Reached Maximum Tolerated Dose (MTD)</title>
          <description>The MTD is the highest dose amongst the different dose-level cohorts in this study at which no more than 2 (33%) of the subjects in a cohort experience DLT.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="1"/>
                <count group_id="O3" value="1"/>
                <count group_id="O4" value="1"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="6"/>
                <count group_id="O7" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects With Prostate Specific Antigen (PSA) Response</title>
        <description>PSA will be analyzed through blood specimen collection</description>
        <time_frame>PSA was assessed at screening, and up to 6 months after first treatment with study drug.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>225Ac-J591 Cohort 1</title>
            <description>Cohort 1: Participants were administered of 225Ac-J591 once at the dose level of 13.3 KBq/Kg - 0.36 Ci/Kg via intravenous infusion (IV). Participants were then followed until death for survival assessment</description>
          </group>
          <group group_id="O2">
            <title>225Ac-J591 Cohort 2</title>
            <description>Cohort 2: Participants were administered of 225Ac-J591 once at the dose level of 26.7 KBq/Kg - 0.72 Ci/Kg via intravenous infusion (IV). Participants were then followed until death for survival assessment.</description>
          </group>
          <group group_id="O3">
            <title>225Ac-J591 Cohort 3</title>
            <description>Cohort 3: Participants were administered of 225Ac-J591 once at the dose level of 40.0 KBq/Kg - 1.08 Ci/Kg via intravenous infusion (IV). Participants were then followed until death for survival assessment.</description>
          </group>
          <group group_id="O4">
            <title>225Ac-J591 Cohort 4</title>
            <description>Cohort 4: Participants were administered of 225Ac-J591 once at the dose level of 53.3 KBq/Kg - 1.44 Ci/Kg via intravenous infusion (IV). Participants were then followed until death for survival assessment.</description>
          </group>
          <group group_id="O5">
            <title>225Ac-J591 Cohort 5</title>
            <description>Cohort 5: Participants were administered of 225Ac-J591 once at the dose level of 66.7 KBq/Kg - 1.80 Ci/Kg via intravenous infusion (IV). Participants were then followed until death for survival assessment.</description>
          </group>
          <group group_id="O6">
            <title>225Ac-J591 Cohort 6</title>
            <description>Cohort 6: Participants were administered of 225Ac-J591 once at the dose level of 80.0 KBq/Kg - 2.16 Ci/Kg via intravenous infusion (IV). Participants were then followed until death for survival assessment.</description>
          </group>
          <group group_id="O7">
            <title>225Ac-J591 Cohort 7</title>
            <description>Cohort 7 with Expansion: Participants were administered of 225Ac-J591 once at the dose level of 93.3 KBq/Kg - 2.52 Ci/Kg via intravenous infusion (IV). Participants were then followed until death for survival assessment.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects With Prostate Specific Antigen (PSA) Response</title>
          <description>PSA will be analyzed through blood specimen collection</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="1"/>
                <count group_id="O3" value="1"/>
                <count group_id="O4" value="1"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="6"/>
                <count group_id="O7" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="3"/>
                    <measurement group_id="O6" value="3"/>
                    <measurement group_id="O7" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects With Circulating Tumor Cells (CTC) Response</title>
        <description>CTCs will be analyzed through blood specimen collection via CellSearch methodology lab testing</description>
        <time_frame>CTC was assessed at screening and 12 weeks after starting study drug.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>225Ac-J591 Cohort 1</title>
            <description>Cohort 1: Participants were administered of 225Ac-J591 once at the dose level of 13.3 KBq/Kg - 0.36 Ci/Kg via intravenous infusion (IV). Participants were then followed until death for survival assessment</description>
          </group>
          <group group_id="O2">
            <title>225Ac-J591 Cohort 2</title>
            <description>Cohort 2: Participants were administered of 225Ac-J591 once at the dose level of 26.7 KBq/Kg - 0.72 Ci/Kg via intravenous infusion (IV). Participants were then followed until death for survival assessment.</description>
          </group>
          <group group_id="O3">
            <title>225Ac-J591 Cohort 3</title>
            <description>Cohort 3: Participants were administered of 225Ac-J591 once at the dose level of 40.0 KBq/Kg - 1.08 Ci/Kg via intravenous infusion (IV). Participants were then followed until death for survival assessment.</description>
          </group>
          <group group_id="O4">
            <title>225Ac-J591 Cohort 4</title>
            <description>Cohort 4: Participants were administered of 225Ac-J591 once at the dose level of 53.3 KBq/Kg - 1.44 Ci/Kg via intravenous infusion (IV). Participants were then followed until death for survival assessment.</description>
          </group>
          <group group_id="O5">
            <title>225Ac-J591 Cohort 5</title>
            <description>Cohort 5: Participants were administered of 225Ac-J591 once at the dose level of 66.7 KBq/Kg - 1.80 Ci/Kg via intravenous infusion (IV). Participants were then followed until death for survival assessment.</description>
          </group>
          <group group_id="O6">
            <title>225Ac-J591 Cohort 6</title>
            <description>Cohort 6: Participants were administered of 225Ac-J591 once at the dose level of 80.0 KBq/Kg - 2.16 Ci/Kg via intravenous infusion (IV). Participants were then followed until death for survival assessment.</description>
          </group>
          <group group_id="O7">
            <title>225Ac-J591 Cohort 7</title>
            <description>Cohort 7 with Expansion: Participants were administered of 225Ac-J591 once at the dose level of 93.3 KBq/Kg - 2.52 Ci/Kg via intravenous infusion (IV). Participants were then followed until death for survival assessment.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects With Circulating Tumor Cells (CTC) Response</title>
          <description>CTCs will be analyzed through blood specimen collection via CellSearch methodology lab testing</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="1"/>
                <count group_id="O3" value="1"/>
                <count group_id="O4" value="1"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="6"/>
                <count group_id="O7" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="5"/>
                    <measurement group_id="O6" value="5"/>
                    <measurement group_id="O7" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects With Radiographic (Imaging) Response</title>
        <description>Radiographic response rate by Response evaluation criteria in solid tumors (RECIST) criteria with Prostate Cancer Working Group 3 (PCWG3) modifications</description>
        <time_frame>Response were assessed for patients throughout their duration on the study, up to 3 years.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>225Ac-J591 Cohort 1</title>
            <description>Cohort 1: Participants were administered of 225Ac-J591 once at the dose level of 13.3 KBq/Kg - 0.36 Ci/Kg via intravenous infusion (IV). Participants were then followed until death for survival assessment</description>
          </group>
          <group group_id="O2">
            <title>225Ac-J591 Cohort 2</title>
            <description>Cohort 2: Participants were administered of 225Ac-J591 once at the dose level of 26.7 KBq/Kg - 0.72 Ci/Kg via intravenous infusion (IV). Participants were then followed until death for survival assessment.</description>
          </group>
          <group group_id="O3">
            <title>225Ac-J591 Cohort 3</title>
            <description>Cohort 3: Participants were administered of 225Ac-J591 once at the dose level of 40.0 KBq/Kg - 1.08 Ci/Kg via intravenous infusion (IV). Participants were then followed until death for survival assessment.</description>
          </group>
          <group group_id="O4">
            <title>225Ac-J591 Cohort 4</title>
            <description>Cohort 4: Participants were administered of 225Ac-J591 once at the dose level of 53.3 KBq/Kg - 1.44 Ci/Kg via intravenous infusion (IV). Participants were then followed until death for survival assessment.</description>
          </group>
          <group group_id="O5">
            <title>225Ac-J591 Cohort 5</title>
            <description>Cohort 5: Participants were administered of 225Ac-J591 once at the dose level of 66.7 KBq/Kg - 1.80 Ci/Kg via intravenous infusion (IV). Participants were then followed until death for survival assessment.</description>
          </group>
          <group group_id="O6">
            <title>225Ac-J591 Cohort 6</title>
            <description>Cohort 6: Participants were administered of 225Ac-J591 once at the dose level of 80.0 KBq/Kg - 2.16 Ci/Kg via intravenous infusion (IV). Participants were then followed until death for survival assessment.</description>
          </group>
          <group group_id="O7">
            <title>225Ac-J591 Cohort 7</title>
            <description>Cohort 7 with Expansion: Participants were administered of 225Ac-J591 once at the dose level of 93.3 KBq/Kg - 2.52 Ci/Kg via intravenous infusion (IV). Participants were then followed until death for survival assessment.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects With Radiographic (Imaging) Response</title>
          <description>Radiographic response rate by Response evaluation criteria in solid tumors (RECIST) criteria with Prostate Cancer Working Group 3 (PCWG3) modifications</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="1"/>
                <count group_id="O3" value="1"/>
                <count group_id="O4" value="1"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="6"/>
                <count group_id="O7" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Progression Free Survival (PFS)</title>
        <description>Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.</description>
        <time_frame>From the start of treatment to progression, up to 3 years</time_frame>
        <group_list>
          <group group_id="O1">
            <title>225Ac-J591 Cohort 1</title>
            <description>Cohort 1: Participants were administered of 225Ac-J591 once at the dose level of 13.3 KBq/Kg - 0.36 Ci/Kg via intravenous infusion (IV). Participants were then followed until death for survival assessment</description>
          </group>
          <group group_id="O2">
            <title>225Ac-J591 Cohort 2</title>
            <description>Cohort 2: Participants were administered of 225Ac-J591 once at the dose level of 26.7 KBq/Kg - 0.72 Ci/Kg via intravenous infusion (IV). Participants were then followed until death for survival assessment.</description>
          </group>
          <group group_id="O3">
            <title>225Ac-J591 Cohort 3</title>
            <description>Cohort 3: Participants were administered of 225Ac-J591 once at the dose level of 40.0 KBq/Kg - 1.08 Ci/Kg via intravenous infusion (IV). Participants were then followed until death for survival assessment.</description>
          </group>
          <group group_id="O4">
            <title>225Ac-J591 Cohort 4</title>
            <description>Cohort 4: Participants were administered of 225Ac-J591 once at the dose level of 53.3 KBq/Kg - 1.44 Ci/Kg via intravenous infusion (IV). Participants were then followed until death for survival assessment.</description>
          </group>
          <group group_id="O5">
            <title>225Ac-J591 Cohort 5</title>
            <description>Cohort 5: Participants were administered of 225Ac-J591 once at the dose level of 66.7 KBq/Kg - 1.80 Ci/Kg via intravenous infusion (IV). Participants were then followed until death for survival assessment.</description>
          </group>
          <group group_id="O6">
            <title>225Ac-J591 Cohort 6</title>
            <description>Cohort 6: Participants were administered of 225Ac-J591 once at the dose level of 80.0 KBq/Kg - 2.16 Ci/Kg via intravenous infusion (IV). Participants were then followed until death for survival assessment.</description>
          </group>
          <group group_id="O7">
            <title>225Ac-J591 Cohort 7</title>
            <description>Cohort 7 with Expansion: Participants were administered of 225Ac-J591 once at the dose level of 93.3 KBq/Kg - 2.52 Ci/Kg via intravenous infusion (IV). Participants were then followed until death for survival assessment.</description>
          </group>
        </group_list>
        <measure>
          <title>Progression Free Survival (PFS)</title>
          <description>Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.</description>
          <units>Days</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="1"/>
                <count group_id="O3" value="1"/>
                <count group_id="O4" value="1"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="6"/>
                <count group_id="O7" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="381" lower_limit="381" upper_limit="381"/>
                    <measurement group_id="O2" value="56" lower_limit="56" upper_limit="56"/>
                    <measurement group_id="O3" value="141" lower_limit="141" upper_limit="141"/>
                    <measurement group_id="O4" value="60" lower_limit="60" upper_limit="60"/>
                    <measurement group_id="O5" value="366" lower_limit="95" upper_limit="940"/>
                    <measurement group_id="O6" value="242" lower_limit="84" upper_limit="777"/>
                    <measurement group_id="O7" value="130" lower_limit="54" upper_limit="334"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Assessed throughout duration of participant on study, up to 3 years.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>225Ac-J591 Cohort 1</title>
          <description>Cohort 1: Participants were administered of 225Ac-J591 once at the dose level of 13.3 KBq/Kg - 0.36 Ci/Kg via intravenous infusion (IV). Participants were then followed until death for survival assessment</description>
        </group>
        <group group_id="E2">
          <title>225Ac-J591 Cohort 2</title>
          <description>Cohort 2: Participants were administered of 225Ac-J591 once at the dose level of 26.7 KBq/Kg - 0.72 Ci/Kg via intravenous infusion (IV). Participants were then followed until death for survival assessment.</description>
        </group>
        <group group_id="E3">
          <title>225Ac-J591 Cohort 3</title>
          <description>Cohort 3: Participants were administered of 225Ac-J591 once at the dose level of 40.0 KBq/Kg - 1.08 Ci/Kg via intravenous infusion (IV). Participants were then followed until death for survival assessment.</description>
        </group>
        <group group_id="E4">
          <title>225Ac-J591 Cohort 4</title>
          <description>Cohort 4: Participants were administered of 225Ac-J591 once at the dose level of 53.3 KBq/Kg - 1.44 Ci/Kg via intravenous infusion (IV). Participants were then followed until death for survival assessment.</description>
        </group>
        <group group_id="E5">
          <title>225Ac-J591 Cohort 5</title>
          <description>Cohort 5: Participants were administered of 225Ac-J591 once at the dose level of 66.7 KBq/Kg - 1.80 Ci/Kg via intravenous infusion (IV). Participants were then followed until death for survival assessment.</description>
        </group>
        <group group_id="E6">
          <title>225Ac-J591 Cohort 6</title>
          <description>Cohort 6: Participants were administered of 225Ac-J591 once at the dose level of 80.0 KBq/Kg - 2.16 Ci/Kg via intravenous infusion (IV). Participants were then followed until death for survival assessment.</description>
        </group>
        <group group_id="E7">
          <title>225Ac-J591 Cohort 7</title>
          <description>Cohort 7 with Expansion: Participants were administered of 225Ac-J591 once at the dose level of 93.3 KBq/Kg - 2.52 Ci/Kg via intravenous infusion (IV). Participants were then followed until death for survival assessment.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>CTCAE 4.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E5" subjects_affected="5" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="15" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="8" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E7" events="2" subjects_affected="2" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Anemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E7" events="2" subjects_affected="2" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Blood bilirubin Increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal Pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Any Pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dyspnea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>CTCAE 4.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E5" subjects_affected="6" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="6" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="16" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E7" events="7" subjects_affected="7" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Anemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E6" events="5" subjects_affected="5" subjects_at_risk="6"/>
                <counts group_id="E7" events="7" subjects_affected="7" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E5" events="4" subjects_affected="4" subjects_at_risk="6"/>
                <counts group_id="E6" events="6" subjects_affected="6" subjects_at_risk="6"/>
                <counts group_id="E7" events="12" subjects_affected="12" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Transaminase</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="2" subjects_affected="2" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Hypocalcemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Increased bilirubin</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="3" subjects_affected="3" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E5" events="4" subjects_affected="4" subjects_at_risk="6"/>
                <counts group_id="E6" events="6" subjects_affected="6" subjects_at_risk="6"/>
                <counts group_id="E7" events="5" subjects_affected="5" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E6" events="4" subjects_affected="4" subjects_at_risk="6"/>
                <counts group_id="E7" events="6" subjects_affected="6" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Xerostomia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E5" events="4" subjects_affected="4" subjects_at_risk="6"/>
                <counts group_id="E6" events="6" subjects_affected="6" subjects_at_risk="6"/>
                <counts group_id="E7" events="5" subjects_affected="5" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E5" events="6" subjects_affected="6" subjects_at_risk="6"/>
                <counts group_id="E6" events="6" subjects_affected="6" subjects_at_risk="6"/>
                <counts group_id="E7" events="15" subjects_affected="15" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Dyspnea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" events="2" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E7" events="3" subjects_affected="3" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Confusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Anorexia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E5" events="6" subjects_affected="6" subjects_at_risk="6"/>
                <counts group_id="E6" events="5" subjects_affected="5" subjects_at_risk="6"/>
                <counts group_id="E7" events="8" subjects_affected="8" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Weight loss</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E7" events="4" subjects_affected="4" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Generalized muscle soreness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Scott Tagawa</name_or_title>
      <organization>Weill Cornell Medicine</organization>
      <phone>646-962-2027</phone>
      <email>stt2007@med.cornell.edu</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


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/NCT03276572
org study id: 1706018281
secondary id: 7R01CA207645-03
nct id: NCT03276572
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This is an open-label, single-center Phase I dose escalation study designed to determine the
      dose-limiting toxicity (DLT) and the maximum tolerated dose (MTD) of 225Ac-J591 in a single
      dose regimen.
This clinical trial is for men with advanced prostate cancer. The purpose of this study is to
      find the highest dose level of the study drug, 225Ac-J591 that can be given without severe
      side effects. The research study is being done because the standard treatments for prostate
      cancer that has spread beyond the prostate gland are intended to minimize the adverse effects
      of the disease. These treatments, however, are not curative. Patients who choose to
      participate in this study will have a screening visit to determine whether or not they are
      eligible to participate in the study. The treatment phase is comprised of 8 visits over
      approximately 12 weeks. The study medication is called 225Ac-J591, and participants will
      receive an infusion of the study drug on the Treatment visit of the study. Upon completion of
      investigational treatment with single dose of 225Ac-J591, subjects will undergo
      68Ga-PSMA-HBED-CC injection and same day PET/CT at the end of study visit to document
      treatment response. Subsequently survival data and additional treatment(s) information will
      be captured from their routine Standard of care (SOC) visits.During the other study visits,
      participants will undergo routine tests and procedures, such as physical examinations, and
      routine blood tests. Some blood tests will be done for research purposes only. After
      completion of therapy, participants may be contacted on a periodic basis to see how they are
      doing.

      Key eligibility:

        -  Open to men age 18 and older.

        -  Diagnosis of progressive metastatic prostate cancer

        -  Have been previously treated for their disease with particular types of therapy.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Subjects With Dose Limiting Toxicities (DLT)
time frame: Assessed from start of treatment to up to 8 weeks after first study drug administration.
description: Count of participants will be measured by the recommended phase II dose in utilizing the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 for DLTs.
measure: Number of Subjects Who Reached Maximum Tolerated Dose (MTD)
time frame: Assessed from start of treatment to up to 8 weeks after first study drug administration.
description: The MTD is the highest dose amongst the different dose-level cohorts in this study at which no more than 2 (33%) of the subjects in a cohort experience DLT.
measure: Number of Subjects With Prostate Specific Antigen (PSA) Response
time frame: PSA was assessed at screening, and up to 6 months after first treatment with study drug.
description: PSA will be analyzed through blood specimen collection
measure: Number of Subjects With Circulating Tumor Cells (CTC) Response
time frame: CTC was assessed at screening and 12 weeks after starting study drug.
description: CTCs will be analyzed through blood specimen collection via CellSearch methodology lab testing
measure: Number of Subjects With Radiographic (Imaging) Response
time frame: Response were assessed for patients throughout their duration on the study, up to 3 years.
description: Radiographic response rate by Response evaluation criteria in solid tumors (RECIST) criteria with Prostate Cancer Working Group 3 (PCWG3) modifications
measure: Progression Free Survival (PFS)
time frame: From the start of treatment to progression, up to 3 years
description: Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
arm group label: All Subjects
arm group type: Experimental
description: A single dose of 225Ac-J591 will be given to subjects with documented progressive metastatic CRPC.
intervention type: Drug
intervention name: 225Ac-J591
description: 225Ac-J591 (13.3 KBq/Kg - 93.3 KBq/Kg or 0.36 uCi/Kg - 2.52 uCi/Kg) on day 1
arm group label: All Subjects
other name: 68Ga-PSMA-HBED-CC injection for PET/CT Scan on day 1 and at end of study
criteria: 
gender: Male
gender based: Yes
gender description: Adult male patients of >18 years age with documented progressive metastatic CRPC
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Scott Tagawa, MD
role: Principal Investigator
affiliation: Weill Medical College of Cornell University
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Prostatic Neoplasms
mesh term: Gallium 68 PSMA-11
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 