<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/NCT03822871</url>
  </required_header>
  <id_info>
    <org_study_id>CTT1403-101</org_study_id>
    <nct_id>NCT03822871</nct_id>
  </id_info>
  <brief_title>A Trial of CTT1403 for Metastatic Castration Resistant Prostate Cancer</brief_title>
  <official_title>A Phase 1 Trial for Evaluation of Safety and 177Lu Radiation Dosimetry of CTT1403: A Peptidomimetic Inhibitor of Prostate Specific Membrane Antigen, in Metastatic Castration Resistant Prostate Cancer (mCRPC)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cancer Targeted Technology</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of California, San Francisco</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Cancer Targeted Technology</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>
      The purpose of this study is to find the highest dose level of study drug, CTT1403, that can&#xD;
      be safely administered to patients with metastatic castration resistant prostate cancer&#xD;
      (mCRPC).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a Phase 1, first-in-human dose escalation/dose expansion study evaluating escalating&#xD;
      doses of CTT1403 in patients with PSMA-avid mCRPC with progressive disease on at least one&#xD;
      androgen signaling inhibitor, followed by a dose expansion to further evaluate the safety,&#xD;
      tolerability, efficacy and biological activity of CTT1403. CTT1403 is a PSMA-targeted&#xD;
      177Lu-labeled radiotherapy being developed for prostate cancer with a unique PSMA binding&#xD;
      scaffold and an albumin binding moiety to extend circulation half-life. The PSMA binding&#xD;
      scaffold is shared with CTT1057, a PSMA-specific PET diagnostic imaging agent shown in Phase&#xD;
      1 clinical trials to be specifically taken up by PSMA+ tumor. PSMA PET imaging by CTT1057&#xD;
      will be used diagnostically to select patients with PSMA-avid disease for treatment. The&#xD;
      purpose of this study is to identify the dose limiting toxicity and recommended phase 2 dose&#xD;
      of CTT1403. Eligible participants with demonstrated therapeutic benefit will be offered a&#xD;
      second dose of study drug.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2019</start_date>
  <completion_date type="Actual">November 15, 2021</completion_date>
  <primary_completion_date type="Actual">November 15, 2021</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Frequency of DLTs at escalating dose levels of CTT1403</measure>
    <time_frame>6-8 weeks from time of injection</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assessment of organ dosimetry of CTT1403 by SPECT/CT imaging at various time points</measure>
    <time_frame>6-8 weeks from time of injection</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in patient reported pain as measured by Brief Pain Index</measure>
    <time_frame>up to 6 months after injection</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">17</enrollment>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>Cohort A-J</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with mCRPC and progressive disease on at least 1 androgen signaling inhibitor will be enrolled.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort K - at Recommended Phase 2 Dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cohort F: Patients with mCRPC and progressive disease on at least 1 androgen signaling inhibitor will be enrolled at the recommended phase 2 dose.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CTT1403</intervention_name>
    <description>Escalating doses of 0.75 GBq - 13.5 GBq will be administered in an accelerated to traditional 3+3 dose escalation design. After escalation, 10 additional patients will be enrolled into a dose expansion cohort. Patients meeting eligibility criteria with demonstrated cessation of disease progression will be offered a second dose of the study drug, CTT1403.</description>
    <arm_group_label>Cohort A-J</arm_group_label>
    <arm_group_label>Cohort K - at Recommended Phase 2 Dose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CTT1057</intervention_name>
    <description>Patients will be screened with CTT1057 or 68Ga-PSMA-11 PSMA PET to demonstrate presence of at least 3 PSMA avid lesions that can be targeted by the study drug, CTT1403. 5-7 weeks after administration of study drug, patients will be evaluated a second time with PSMA PET imaging using with either CTT1057 or 68Ga-PSMA-11 to assess potential efficacy of CTT1403.</description>
    <arm_group_label>Cohort A-J</arm_group_label>
    <arm_group_label>Cohort K - at Recommended Phase 2 Dose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>68Ga-PSMA-11</intervention_name>
    <description>Patients will be screened with CTT1057 or 68Ga-PSMA-11 PSMA PET to demonstrate presence of at least 3 PSMA avid lesions that can be targeted by the study drug, CTT1403. 5-7 weeks after administration of study drug, patients will be evaluated a second time with PSMA PET imaging using with either CTT1057 or 68Ga-PSMA-11 to assess potential efficacy of CTT1403.</description>
    <arm_group_label>Cohort A-J</arm_group_label>
    <arm_group_label>Cohort K - at Recommended Phase 2 Dose</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients must have histologically confirmed prostate adenocarcinoma that is metastatic&#xD;
             and castration resistant (mCRPC).&#xD;
&#xD;
          -  At least 3 metastatic foci avid for PSMA-specific PET agent (CTT1057) uptake on&#xD;
             Screening PSMA PET.&#xD;
&#xD;
          -  Has received docetaxol, ineligible for docetaxol, or refused docetaxol for the&#xD;
             treatment of prostate cancer.&#xD;
&#xD;
          -  Has progression by the PCWG3 criteria during or after treatment with either&#xD;
             abiraterone or enzalutamide&#xD;
&#xD;
          -  Male Age ≥ 18 years.&#xD;
&#xD;
          -  Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (see&#xD;
             Appendix 2).&#xD;
&#xD;
        Demonstrate adequate organ function&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Has received previous treatment with radium-223 or another radiopharmaceutical within&#xD;
             3 months prior to first dose of CTT1403.&#xD;
&#xD;
          -  Has received cabazitaxel for the treatment of mCRPC.&#xD;
&#xD;
          -  Has received previous treatment with a therapeutic targeting PSMA.&#xD;
&#xD;
          -  Has an additional active malignancy requiring therapy that may confound the assessment&#xD;
             of the study endpoints.&#xD;
&#xD;
          -  Has clinically significant cardiovascular disease&#xD;
&#xD;
          -  Has a history of untreated brain metastases&#xD;
&#xD;
          -  Has a condition requiring systemic treatment with either corticosteroids (&gt; 10 mg&#xD;
             daily prednisone equivalents) or other immunosuppressive medications within 14 days&#xD;
             before CTT1403 administration.&#xD;
&#xD;
          -  Has known positive status for chronic hepatitis B or hepatitis C&#xD;
&#xD;
          -  Known or suspected myelodysplastic syndrome.&#xD;
&#xD;
          -  Has any medical condition which in the opinion of the Investigator places the patient&#xD;
             at an unacceptably high risk for toxicities.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Prostate cancer is a disease only occurring in males.</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Beatrice Langton-Webster, PHD</last_name>
    <role>Study Chair</role>
    <affiliation>Cancer Targeted Technology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of California, San Francisco</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>9410794143</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>January 28, 2019</study_first_submitted>
  <study_first_submitted_qc>January 29, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 30, 2019</study_first_posted>
  <last_update_submitted>February 13, 2023</last_update_submitted>
  <last_update_submitted_qc>February 13, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 15, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>prostate cancer</keyword>
  <keyword>metastatic castration resistant prostate cancer</keyword>
  <keyword>prostate specific membrane antigen</keyword>
  <keyword>mCRPC</keyword>
  <keyword>PSMA</keyword>
  <keyword>positron emission tomography</keyword>
  <keyword>PET</keyword>
  <keyword>radiotherapy</keyword>
  <keyword>targeted therapy</keyword>
  <keyword>lutetium</keyword>
  <keyword>177Lu</keyword>
  <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>
  <pending_results>
    <submitted>April 26, 2023</submitted>
  </pending_results>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03822871
org study id: CTT1403-101
nct id: NCT03822871
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to find the highest dose level of study drug, CTT1403, that can
      be safely administered to patients with metastatic castration resistant prostate cancer
      (mCRPC).
This is a Phase 1, first-in-human dose escalation/dose expansion study evaluating escalating
      doses of CTT1403 in patients with PSMA-avid mCRPC with progressive disease on at least one
      androgen signaling inhibitor, followed by a dose expansion to further evaluate the safety,
      tolerability, efficacy and biological activity of CTT1403. CTT1403 is a PSMA-targeted
      177Lu-labeled radiotherapy being developed for prostate cancer with a unique PSMA binding
      scaffold and an albumin binding moiety to extend circulation half-life. The PSMA binding
      scaffold is shared with CTT1057, a PSMA-specific PET diagnostic imaging agent shown in Phase
      1 clinical trials to be specifically taken up by PSMA+ tumor. PSMA PET imaging by CTT1057
      will be used diagnostically to select patients with PSMA-avid disease for treatment. The
      purpose of this study is to identify the dose limiting toxicity and recommended phase 2 dose
      of CTT1403. Eligible participants with demonstrated therapeutic benefit will be offered a
      second dose of study drug.
allocation: Non-Randomized
intervention model: Sequential Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Frequency of DLTs at escalating dose levels of CTT1403
time frame: 6-8 weeks from time of injection
measure: Assessment of organ dosimetry of CTT1403 by SPECT/CT imaging at various time points
time frame: 6-8 weeks from time of injection
measure: Change from baseline in patient reported pain as measured by Brief Pain Index
time frame: up to 6 months after injection
arm group label: Cohort A-J
arm group type: Experimental
description: Patients with mCRPC and progressive disease on at least 1 androgen signaling inhibitor will be enrolled.
arm group label: Cohort K - at Recommended Phase 2 Dose
arm group type: Experimental
description: Cohort F: Patients with mCRPC and progressive disease on at least 1 androgen signaling inhibitor will be enrolled at the recommended phase 2 dose.
intervention type: Drug
intervention name: CTT1403
description: Escalating doses of 0.75 GBq - 13.5 GBq will be administered in an accelerated to traditional 3+3 dose escalation design. After escalation, 10 additional patients will be enrolled into a dose expansion cohort. Patients meeting eligibility criteria with demonstrated cessation of disease progression will be offered a second dose of the study drug, CTT1403.
arm group label: Cohort A-J
arm group label: Cohort K - at Recommended Phase 2 Dose
intervention type: Drug
intervention name: CTT1057
description: Patients will be screened with CTT1057 or 68Ga-PSMA-11 PSMA PET to demonstrate presence of at least 3 PSMA avid lesions that can be targeted by the study drug, CTT1403. 5-7 weeks after administration of study drug, patients will be evaluated a second time with PSMA PET imaging using with either CTT1057 or 68Ga-PSMA-11 to assess potential efficacy of CTT1403.
arm group label: Cohort A-J
arm group label: Cohort K - at Recommended Phase 2 Dose
intervention type: Drug
intervention name: 68Ga-PSMA-11
description: Patients will be screened with CTT1057 or 68Ga-PSMA-11 PSMA PET to demonstrate presence of at least 3 PSMA avid lesions that can be targeted by the study drug, CTT1403. 5-7 weeks after administration of study drug, patients will be evaluated a second time with PSMA PET imaging using with either CTT1057 or 68Ga-PSMA-11 to assess potential efficacy of CTT1403.
arm group label: Cohort A-J
arm group label: Cohort K - at Recommended Phase 2 Dose
criteria: 
gender: Male
gender based: Yes
gender description: Prostate cancer is a disease only occurring in males.
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Beatrice Langton-Webster, PHD
role: Study Chair
affiliation: Cancer Targeted Technology
facility: 
country: United States
responsible party type: Sponsor
mesh term: Prostatic Neoplasms
mesh term: Gallium 68 PSMA-11
sharing ipd: No
submitted: April 26, 2023