<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/NCT03773133</url>
  </required_header>
  <id_info>
    <org_study_id>D-FR-01072-002</org_study_id>
    <secondary_id>2017-005173-39</secondary_id>
    <nct_id>NCT03773133</nct_id>
  </id_info>
  <brief_title>Evaluate the Safety, Tolerability, Biodistribution and Anti Tumour Activity of 177LU-OPS201 With Companion Imaging 68Ga-OPS202 PET/CT in Previously Treated Subjects With Locally Advanced or Metastatic Cancers Expressing Somatostatin Receptor 2 (SSTR2)</brief_title>
  <acronym>SSTR2+</acronym>
  <official_title>A Multicentre, Open-Label Phase I/II Study to Evaluate the Safety, Tolerability, Biodistribution and Anti Tumour Activity of 177LU-OPS201 With Companion Imaging 68Ga OPS202 PET/CT in Previously Treated Subjects With Locally Advanced or Metastatic Cancers Expressing Somatostatin Receptor 2 (SSTR2)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ipsen</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ipsen</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 study consists of two phases. The phase I study is designed to investigate the safety&#xD;
      and tolerability of Satoreotide tetraxetan following fractionated i.v. administrations in&#xD;
      pre-treated subjects with locally advanced or metastatic cancers expressing sstr2 as&#xD;
      identified by Satoreotide trizoxetan Positron Emission Tomography (PET/CT) scans. This phase&#xD;
      will encompass both radioactivity escalation and peptide mass dose evaluation. Phase II will&#xD;
      assess the efficacy of Satoreotide tetraxetan in subjects in selected indications, in a&#xD;
      basket design.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    High number of screen failures&#xD;
  </why_stopped>
  <start_date type="Actual">May 14, 2019</start_date>
  <completion_date type="Actual">October 10, 2019</completion_date>
  <primary_completion_date type="Actual">October 10, 2019</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Maximum Tolerated Cumulative Activity - Phase I</measure>
    <time_frame>From Day 1 (first administration of 177Lu-satoreotide tetraxetan) up to 6 weeks after the second administration; no longer applicable due to early study termination.</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Objective Response Rate Over the Two Treatment Cycles - Phase II</measure>
    <time_frame>6 weeks after each administration of 177Lu-satoreotide tetraxetan during the core study or at occurrence of first clinical signs of disease progression as determined by the investigator, up to 90 days; no longer applicable due to early study termination.</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">9</enrollment>
  <condition>Small Cell Lung Cancer and Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>i.v. administrations of up to three radioactivity levels of Satoreotide tetraxetan.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Satoreotide tetraxetan</intervention_name>
    <description>Radioactivity delivered in 2 administrations (cycles): one loading dose followed by a lower maintenance dose, 6 weeks apart until progression or unacceptable toxicity (up to 4 additional cycles could be administered depending on efficacy and tolerability).</description>
    <arm_group_label>Treatment</arm_group_label>
    <other_name>177Lu-OPS201</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Satoreotide trizoxetan</intervention_name>
    <description>Imaging companion: 1 administration at screening and one administration at End of core Trial cycle.</description>
    <arm_group_label>Treatment</arm_group_label>
    <other_name>68Ga-OPS202</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Consenting adults of Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or&#xD;
             1&#xD;
&#xD;
          -  Histologically confirmed locally advanced or metastatic disease which has progressed&#xD;
             during or after, failed to respond to, or for which there is poor tolerability or&#xD;
             after a contraindication to available Standard of Care (SoC) treatment options as per&#xD;
             the assessment of the investigator; initially, subjects with the disease below may be&#xD;
             considered:&#xD;
&#xD;
               1. Subjects who had Extensive Disease (ED-SCLC) at presentation who have progressed&#xD;
                  on or after one line standard chemotherapy. If a subject had Limited Disease&#xD;
                  (LD-SCLC) at presentation and received surgery and/or radiotherapy as first line&#xD;
                  treatment (with or without chemotherapy) and has localized relapse, further local&#xD;
                  treatment (such as surgery) should be considered in addition to the chemotherapy&#xD;
                  options; For subjects with either ED-SCLC or LD-SCLC, if subjects relapse more&#xD;
                  than 6 months after first-line treatment, re-treatment with their initial regimen&#xD;
                  is recommended. Subjects may have received prior immunotherapy.&#xD;
&#xD;
               2. Subjects with Human Epidermal Growth Factor Receptor (HR+)/(HER2-) metastatic BC&#xD;
                  after a failure of prior SoC-treatments and who have received, if indicated, at&#xD;
                  least one line of hormonal therapy, Cyclin-dependent kinase (CDK4/6) inhibitor&#xD;
                  and/or everolimus for advanced or metastatic disease and at least one line of&#xD;
                  chemotherapy for metastatic disease; subjects with a Breast Cancer (BRCA)-mutated&#xD;
                  metastatic disease who may have received a Poly adenosine diphosphate ribose&#xD;
                  polymerase (PARP) inhibitor, if available, are eligible; prior adjuvant hormonal&#xD;
                  treatment and prior adjuvant chemotherapy are allowed.&#xD;
&#xD;
          -  Documented progressive disease (radiological, based on RECIST v1.1) within 3 months&#xD;
             prior to first study drug administration. Screening study-related images should be&#xD;
             sent to the Imaging core laboratory (ICL).&#xD;
&#xD;
          -  Adequate organ function determined within 28 days prior to 177Lu-OPS201&#xD;
             administration, defined as follows:&#xD;
&#xD;
               -  Haematological: white blood cells (WBC) ≥3000/μL, with absolute neutrophil count&#xD;
                  ≥1000/μL, platelet ≥100,000/μL and haemoglobin ≥9 g/dL (without a need for&#xD;
                  hematopoietic growth factor or transfusion support).&#xD;
&#xD;
               -  Renal: Estimated glomerular filtration rate (eGFR) ≥55 mL/minute/1.73m2&#xD;
&#xD;
               -  Hepatic: total serum bilirubin ≤2×ULN; aspartate aminotransferase/ alanine&#xD;
                  aminotransferase ≤2.5×ULN (≤5×ULN if a subject has liver metastases)&#xD;
&#xD;
          -  Formalin fixed paraffin embedded tumour sample (archival tumour sample obtained within&#xD;
             1 month prior to concent from the primary or metastatic lesion OR is willing to&#xD;
             undergo newly obtained biopsy prior to the first dose of study treatment. Subjects who&#xD;
             are unable or do not concent to provide acceptable tissue may not be enrolled unless&#xD;
             there has been prior agreement with the sponsor.&#xD;
&#xD;
          -  68Ga OPS202 uptake in the target tissue (a primary tumour, lymph nodes longest&#xD;
             diameter on PET/CT as confirmed by a central reader.&#xD;
&#xD;
          -  Radiologically, ≥50% matching between the lesions detected on 68Ga OPS202-PET/CT and&#xD;
             on 18F-fluorodeoxyglucose (18F-FDG)-PET/CT as confirmed by central reader&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Male subjects with BC.&#xD;
&#xD;
          -  Unstable central nervous system metastasis&#xD;
&#xD;
          -  Centrally located lung tumours that show radiogical evidence (CT or MRI) of either:&#xD;
&#xD;
               -  cavitation or necrosis, or&#xD;
&#xD;
               -  focal invasion for major blood vessels.&#xD;
&#xD;
          -  Subjects had received chemotherapy within the previous 4 weeks or had not recovered&#xD;
             from adverse events due to chemotherapy. Additional exclusion criteria were previous&#xD;
             hemibody external radiotherapy, systemic radiotherapy with radioisotopes within the&#xD;
             previous 24 weeks&#xD;
&#xD;
          -  Previous chemotherapy within a cycle interval, curative radiotherapy within 4 weeks or&#xD;
             palliative radiotherapy within 7 days prior to Investigational radiopharmaceutical&#xD;
             product (IRPP) administration.&#xD;
&#xD;
          -  Prior treatment with any other investigational medicinal product (IMP) within five&#xD;
             half-lives of the previous IMP or within 2 weeks, if the previous compound is a&#xD;
             mechanism-based molecularly targeted agent whose half-life is not well characterized&#xD;
             and toxicities have not resolved from Grade 2 or higher prior to IRPP administration.&#xD;
&#xD;
          -  Any unresolved NCI-CTCAE Grade 2 or higher toxicity (except alopecia and Grade 2&#xD;
             platinum-therapy related neuropathy) from previous antitumour treatment and/or&#xD;
             medical/surgical procedures/interventions.&#xD;
&#xD;
          -  Nephrectomy, renal transplant or concomitant nephrotoxic therapy putting the subject&#xD;
             at high risk of renal toxicity during the study as assessed by the investigator.&#xD;
&#xD;
          -  Any significant medical or surgical condition that would affect safety or the&#xD;
             assessment of efficacy or the ability of a person to comply with the protocol.&#xD;
&#xD;
          -  Any condition that precludes the proper performance of PET and/or SPECT scans, CT&#xD;
             scans and/or MRI:&#xD;
&#xD;
               1. subjects who are not able to tolerate the CT contrast agent.&#xD;
&#xD;
               2. subjects with metal implants or joint prosthesis (depending on the location, if&#xD;
                  interferes with the PET and/or CT analysis)&#xD;
&#xD;
               3. or any other objects that might interfere with the PET and/or CT analysis.&#xD;
&#xD;
               4. subjects unable to raise arms for prolonged imaging purposes.&#xD;
&#xD;
               5. subjects unable to lie still for the entire imaging time.&#xD;
&#xD;
               6. subjects weighing greater than 130 kg (287 lb).&#xD;
&#xD;
          -  Pregnant or lactating female. Female subject of childbearing potential who is&#xD;
             unwilling to use acceptable method(s) of effective contraception during study&#xD;
             treatment and through 6 months after the last dose of 177Lu-OPS201.&#xD;
&#xD;
          -  Male subject who is unwilling to use acceptable method of effective contraception&#xD;
             during treatment and through 6 months after the last dose of 177Lu-OPS201.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ipsen Medical Director</last_name>
    <role>Study Director</role>
    <affiliation>Ipsen</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>MD Anderson Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical University of Innsbruck</name>
      <address>
        <city>Innsbruck</city>
        <zip>6020</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital (UZ) Leuven</name>
      <address>
        <city>Leuven</city>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Marseille - Hôpital la Timone</name>
      <address>
        <city>Marseille</city>
        <zip>13385</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Bordeaux - Hôpital Haut Lévêque</name>
      <address>
        <city>Pessac</city>
        <zip>33604</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum Essen</name>
      <address>
        <city>Essen</city>
        <zip>45122</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Basel</name>
      <address>
        <city>Basel</city>
        <zip>CH-4031</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Marsden Hospital - Surrey</name>
      <address>
        <city>Sutton</city>
        <zip>SM2 5PT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
    <country>Belgium</country>
    <country>France</country>
    <country>Germany</country>
    <country>Switzerland</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>November 30, 2018</study_first_submitted>
  <study_first_submitted_qc>December 10, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 12, 2018</study_first_posted>
  <results_first_submitted>October 8, 2020</results_first_submitted>
  <results_first_submitted_qc>October 8, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">October 30, 2020</results_first_posted>
  <last_update_submitted>August 22, 2022</last_update_submitted>
  <last_update_submitted_qc>August 22, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 13, 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>Small Cell Lung Carcinoma</mesh_term>
    <mesh_term>Neoplasm Metastasis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>1,4,7,10-tetraazacyclododecane- 1,4,7,10-tetraacetic acid</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>March 7, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/33/NCT03773133/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>January 3, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/33/NCT03773133/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>This phase I/II, multicenter, open-label single-arm study of 177Lu-satoreotide tetraxetan therapy with companion diagnostic imaging Gallium-68 (68Ga)-satoreotide trizoxetan (formerly 68Ga-OPS202) positron emission tomography (PET)/computed tomography (CT) was terminated early on 20 November 2019 due to unsuccessful screening.</recruitment_details>
      <pre_assignment_details>Overall, 9 subjects were enrolled of which 8 received the screening investigational imaging product (IIP) 68Ga-satoreotide trizoxetan and 1 did not due to consent withdrawn by subject. None of the subjects received the therapeutic investigational radiopharmaceutical product (IRPP), 177Lu-satoreotide tetraxetan.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Screened Subjects</title>
          <description>In the screening period, 8 subjects received a single intravenous (i.v.) injection of IIP, 68Ga-satoreotide trizoxetan with a peptide mass of up to 45 micrograms (ug) and a radioactivity dose range of 150-200 Megabequerel (MBq) for screening purposes. The PET images were acquired at 1-hour post injection and 1 contrast enhanced CT scan was performed.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received the Screening IIP</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received the Therapeutic IRPP</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Screen Failure</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Baseline characteristics are reported for all subjects who received at least 1 dose of the IIP, 68Ga-satoreotide trizoxetan for screening purposes.</population>
      <group_list>
        <group group_id="B1">
          <title>Screened Subjects</title>
          <description>In the screening period, 8 subjects received a single i.v. injection of IIP, 68Ga-satoreotide trizoxetan with a peptide mass of up to 45 ug and a radioactivity dose range of 150-200 MBq for screening purposes. The PET images were acquired at 1-hour post injection and 1 contrast enhanced CT scan was performed.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="8"/>
          </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_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </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="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" 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_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Maximum Tolerated Cumulative Activity - Phase I</title>
        <time_frame>From Day 1 (first administration of 177Lu-satoreotide tetraxetan) up to 6 weeks after the second administration; no longer applicable due to early study termination.</time_frame>
        <population>No efficacy data was collected since none of the subjects received the IRPP, 177Lu-satoreotide tetraxetan.</population>
        <group_list>
          <group group_id="O1">
            <title>All Subjects - Phase I</title>
            <description>In the core treatment period of Phase I, eligible subjects were to receive up to 2 i.v. administrations of 177Lu-satoreotide tetraxetan. A range of cumulative radioactivities from 9 to 12.9 Gigabecquerels of 177Lu-satoreotide tetraxetan, fractionated into 2 administrations 6 weeks apart, were planned to be tested.</description>
          </group>
        </group_list>
        <measure>
          <title>Maximum Tolerated Cumulative Activity - Phase I</title>
          <population>No efficacy data was collected since none of the subjects received the IRPP, 177Lu-satoreotide tetraxetan.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Objective Response Rate Over the Two Treatment Cycles - Phase II</title>
        <time_frame>6 weeks after each administration of 177Lu-satoreotide tetraxetan during the core study or at occurrence of first clinical signs of disease progression as determined by the investigator, up to 90 days; no longer applicable due to early study termination.</time_frame>
        <population>No efficacy data was collected since none of the subjects received the IRPP, 177Lu-satoreotide tetraxetan.</population>
        <group_list>
          <group group_id="O1">
            <title>All Subjects - Phase II</title>
            <description>Subjects were to receive the recommended Phase II 177Lu-satoreotide tetraxetan treatment regimen based on the dose-response and exposure-response analyses of Phase I. It was expected that 2 treatment cycles of 177Lu-satoreotide tetraxetan would be administered in subjects enrolled in Phase II.</description>
          </group>
        </group_list>
        <measure>
          <title>Objective Response Rate Over the Two Treatment Cycles - Phase II</title>
          <population>No efficacy data was collected since none of the subjects received the IRPP, 177Lu-satoreotide tetraxetan.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Treatment-emergent adverse events were assessed after first administration of the IIP, 68Ga-satoreotide trizoxetan, until the data cut-off for study termination (maximum of 21 weeks).</time_frame>
      <group_list>
        <group group_id="E1">
          <title>68Ga-satoreotide Trizoxetan Safety Population</title>
          <description>The 68Ga-satoreotide trizoxetan safety population included all subjects who received at least 1 dose of 68Ga-satoreotide trizoxetan.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA 20.1</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="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Iodine allergy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There IS 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>
    <limitations_and_caveats>This study was terminated early due to unsuccessful screening and not due to subjects' safety. No outcomes measures were evaluated as no subjects received the therapeutic IRPP, 177Lu-satoreotide tetraxetan.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Ipsen Medical Director</name_or_title>
      <organization>Ipsen</organization>
      <phone>See email</phone>
      <email>clinical.trials@ipsen.com</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/NCT03773133
org study id: D-FR-01072-002
secondary id: 2017-005173-39
nct id: NCT03773133
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This study consists of two phases. The phase I study is designed to investigate the safety
      and tolerability of Satoreotide tetraxetan following fractionated i.v. administrations in
      pre-treated subjects with locally advanced or metastatic cancers expressing sstr2 as
      identified by Satoreotide trizoxetan Positron Emission Tomography (PET/CT) scans. This phase
      will encompass both radioactivity escalation and peptide mass dose evaluation. Phase II will
      assess the efficacy of Satoreotide tetraxetan in subjects in selected indications, in a
      basket design.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Maximum Tolerated Cumulative Activity - Phase I
time frame: From Day 1 (first administration of 177Lu-satoreotide tetraxetan) up to 6 weeks after the second administration; no longer applicable due to early study termination.
measure: Objective Response Rate Over the Two Treatment Cycles - Phase II
time frame: 6 weeks after each administration of 177Lu-satoreotide tetraxetan during the core study or at occurrence of first clinical signs of disease progression as determined by the investigator, up to 90 days; no longer applicable due to early study termination.
arm group label: Treatment
arm group type: Experimental
description: i.v. administrations of up to three radioactivity levels of Satoreotide tetraxetan.
intervention type: Drug
intervention name: Satoreotide tetraxetan
description: Radioactivity delivered in 2 administrations (cycles): one loading dose followed by a lower maintenance dose, 6 weeks apart until progression or unacceptable toxicity (up to 4 additional cycles could be administered depending on efficacy and tolerability).
arm group label: Treatment
other name: 177Lu-OPS201
intervention type: Drug
intervention name: Satoreotide trizoxetan
description: Imaging companion: 1 administration at screening and one administration at End of core Trial cycle.
arm group label: Treatment
other name: 68Ga-OPS202
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ipsen Medical Director
role: Study Director
affiliation: Ipsen
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Austria
country: Belgium
country: France
country: Germany
country: Switzerland
country: United Kingdom
country: United States
responsible party type: Sponsor
mesh term: Small Cell Lung Carcinoma
mesh term: Neoplasm Metastasis
mesh term: 1,4,7,10-tetraazacyclododecane- 1,4,7,10-tetraacetic acid
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: This study was terminated early due to unsuccessful screening and not due to subjects' safety. No outcomes measures were evaluated as no subjects received the therapeutic IRPP, 177Lu-satoreotide tetraxetan.
point of contact: 