xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05999292</url>
    </required_header>
    <id_info>
      <org_study_id>R8760-101</org_study_id>
      <nct_id>NCT05999292</nct_id>
    </id_info>
    <brief_title>Phase 1 Study of 68Ga-R8760</brief_title>
    <official_title>Phase 1 Safety and Dosimetry Study of 68Ga-R8760 in Patients With Adrenocortical Carcinoma and Healthy Volunteers</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Radionetics Oncology</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Radionetics Oncology</source>
    <oversight_info>
      <has_dmc>No</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>
        A Phase 1 Safety and Dosimetry Study of 68Ga-R8760 in Patients with Adrenocortical Carcinoma&#xD;
        and Healthy Volunteers&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">April 2024</completion_date>
    <primary_completion_date type="Anticipated">April 2024</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>Diagnostic</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Incidence of adverse events characterized overall and by type, frequency, seriousness, relationship to study drug, timing and severity graded according to the NCI-CTCAE v5.0; absolute values and changes in clinical laboratory parameters</measure>
      <time_frame>7 days</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Absorbed dose coefficients (mGy/MBq) in target organs and the effective dose coefficient (mSv/MBq)</measure>
      <time_frame>1 day</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Number and location of tumors identified by 68Ga-R8760 PET/CT and by anatomic images</measure>
      <time_frame>1 day</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Maximum standard uptake value (SUVmax) of each tumor and of source organ</measure>
      <time_frame>1 day</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Ratio of the tumor SUV over reference region SUV</measure>
      <time_frame>1 day</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Area under the plasma concentration versus time curse (AUC)</measure>
      <time_frame>1 day</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Maximum plasma concentration (Cmax)</measure>
      <time_frame>1 day</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Half-life (T1/2) of 68Ga-R8760</measure>
      <time_frame>1 day</time_frame>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">25</enrollment>
    <condition>Adrenocortical Carcinoma</condition>
    <arm_group>
      <arm_group_label>68Ga-R8760 Dose Selection (Part 1)</arm_group_label>
      <arm_group_type>Other</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>68Ga-R8760 Expansion Cohort (Part 2)</arm_group_label>
      <arm_group_type>Other</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>68Ga-R8760 injection at pre-defined dose levels</intervention_name>
      <description>PET/CT imaging at predefined timepoints</description>
      <arm_group_label>68Ga-R8760 Dose Selection (Part 1)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>68Ga-R8760 injection</intervention_name>
      <description>PET/CT imaging at a single timepoint</description>
      <arm_group_label>68Ga-R8760 Expansion Cohort (Part 2)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Adrenocortical Carcinoma Subjects&#xD;
  &#xD;
          Inclusion Criteria:&#xD;
  &#xD;
            1. Pathologically confirmed ACC.&#xD;
  &#xD;
            2. Newly diagnosed or recurrent/relapsed ACC with at least 1 measurable target lesion per&#xD;
               RECIST v1.1 criteria.&#xD;
  &#xD;
            3. Male or non-pregnant, non-lactating female subjects age ≥18 years.&#xD;
  &#xD;
            4. Female subjects of childbearing potential and male subjects (if sexually active) must&#xD;
               agree to use adequate method(s) of effective contraception during their participation&#xD;
               in the study.&#xD;
  &#xD;
            5. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2.&#xD;
  &#xD;
            6. Adequate hepatic function as defined below:&#xD;
  &#xD;
                 1. Serum alanine aminotransaminase (ALT)/ aspartate aminotransaminase (AST) ≤3 ×&#xD;
                    upper limit of normal (ULN) or ≤5 × ULN if liver metastases are present or&#xD;
                    received prior mitotane therapy, and&#xD;
  &#xD;
                 2. Serum bilirubin - total ≤1.5 × ULN (unless due to Gilbert's syndrome or hemolysis&#xD;
                    in which case total ≤3.0 × ULN).&#xD;
  &#xD;
            7. Adequate renal function as measured by creatinine clearance calculated by the&#xD;
               Cockcroft-Gault formula (≥60 mL/minute).&#xD;
  &#xD;
            8. Able to understand and willing to sign a written informed consent form.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Administered a radionuclide within a period of time corresponding to less than 10&#xD;
               physical half-lives of the radionuclide prior to study Day 1.&#xD;
  &#xD;
            2. Radiotherapy ≤14 days prior to study Day 1.&#xD;
  &#xD;
            3. Major surgery ≤21 days prior to study Day 1 or has not recovered from adverse effects&#xD;
               of such procedure.&#xD;
  &#xD;
            4. Severe or unstable medical condition, such as congestive heart failure (New York Heart&#xD;
               Association [NYHA] Class III or IV), ischemic heart disease, uncontrolled&#xD;
               hypertension, uncontrolled diabetes mellitus, as well as an uncontrolled cardiac&#xD;
               arrhythmia requiring medication (≥Grade 2, according to NCI-CTCAE Version 5.0),&#xD;
               myocardial infarction within 6 months prior to starting study drug, or any other&#xD;
               significant or unstable concurrent cardiac illness. Note: Stable chronic atrial&#xD;
               fibrillation is allowed.&#xD;
  &#xD;
            5. Congenital long QT syndrome or corrected QT interval by Fridericia (QTcF) interval&#xD;
               &gt;450 msec (males) or &gt;470 msec (females).&#xD;
  &#xD;
            6. History of cerebrovascular accident within 6 months or that resulted in ongoing&#xD;
               neurologic instability.&#xD;
  &#xD;
            7. History of other previous or concurrent cancer that would interfere with the&#xD;
               determination of safety.&#xD;
  &#xD;
            8. Major active infection requiring antibiotics.&#xD;
  &#xD;
            9. Known active human immunodeficiency virus infection or active infection with Hepatitis&#xD;
               B or C.&#xD;
  &#xD;
           10. Acute illness within 14 days prior to study Day 1unless mild in severity, as assessed&#xD;
               by the Investigator.&#xD;
  &#xD;
           11. Any other condition that in the opinion of the Investigator would place the subject at&#xD;
               an unacceptable risk or cause the subject to be unlikely to fully participate or&#xD;
               comply with study procedures.&#xD;
  &#xD;
          Healthy Volunteers&#xD;
  &#xD;
          Inclusion Criteria:&#xD;
  &#xD;
            1. Healthy male or non-pregnant, non-lactating female subjects aged between 18 and 59&#xD;
               years (inclusive).&#xD;
  &#xD;
            2. Female subjects of childbearing potential and male subjects (if sexually active) must&#xD;
               agree to use adequate method(s) of effective contraception during their participation&#xD;
               in the study.&#xD;
  &#xD;
            3. Body mass index between 18.0 and 32.0 kg/m2 (inclusive).&#xD;
  &#xD;
            4. Adequate renal function as measured by creatinine clearance calculated at ≥60&#xD;
               mL/minute by the Cockcroft-Gault formula.&#xD;
  &#xD;
            5. Able to understand and willing to sign a written informed consent form.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Prior unilateral or bilateral adrenalectomy.&#xD;
  &#xD;
            2. Mental or legal incapacitation.&#xD;
  &#xD;
            3. History of significant hypersensitivity, intolerance, or allergy to any drug compound,&#xD;
               food, or other substance, unless approved by the Investigator (or designee).&#xD;
  &#xD;
            4. Subjects diagnosed with adrenal disease, including Cushing's syndrome, adrenal&#xD;
               insufficiency, or congenital adrenal hyperplasia.&#xD;
  &#xD;
            5. Glucocorticoid steroid use (including topical) within 4 weeks prior to study Day 1&#xD;
               (inhaled steroids are allowed).&#xD;
  &#xD;
            6. Active or recent (within 30 days of screening) infection or history of recurrent&#xD;
               chronic infections with underlying condition that may predispose one to infections.&#xD;
  &#xD;
            7. Resting pulse rate ≥100 or &lt;40 beats per minute at screening. If abnormal, a repeat&#xD;
               measurement will be conducted to confirm.&#xD;
  &#xD;
            8. Systolic blood pressure &gt;160 or &lt;90 mmHg or diastolic blood pressure &gt;90 or &lt;50 mmHg,&#xD;
               unless judged by the Investigator to have no clinical significance.&#xD;
  &#xD;
            9. Participation in a clinical study involving administration of an investigational drug&#xD;
               in the past 30 days or 5 half-lives (whichever is longer) prior to study Day 1.&#xD;
  &#xD;
           10. Administered a radionuclide within a period of time corresponding to less than 10&#xD;
               physical half-lives of the radionuclide prior to study Day 1.&#xD;
  &#xD;
           11. Donation of blood or significant blood loss within 3 months prior to screening,&#xD;
               donation of plasma within 2 weeks prior to screening, or donation of platelets within&#xD;
               6 weeks prior to screening.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Istvan Molnar, MD</last_name>
      <phone>201-912-6062</phone>
      <email>imolnar@radionetics.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Adina Robinson</last_name>
      <phone>303-915-0344</phone>
      <email>arobinson@radionetics.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>University of Michigan Nuclear Medicine</name>
        <address>
          <city>Ann Arbor</city>
          <state>Michigan</state>
          <zip>48109</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>James Pool</last_name>
        <phone>734-735-3130</phone>
        <email>jampool@med.umich.edu</email>
      </contact>
      <investigator>
        <last_name>Benjamin Viglianti, MD PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 27, 2023</study_first_submitted>
    <study_first_submitted_qc>August 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 24, 2023</last_update_submitted>
    <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Adrenocortical Carcinoma</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Carcinoma</mesh_term>
      <mesh_term>Adrenocortical Carcinoma</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05999292
  org study id: R8760-101
  nct id: NCT05999292
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  A Phase 1 Safety and Dosimetry Study of 68Ga-R8760 in Patients with Adrenocortical Carcinoma
        and Healthy Volunteers
  allocation: Non-Randomized
  intervention model: Sequential Assignment
  primary purpose: Diagnostic
  masking: None (Open Label)
  measure: Incidence of adverse events characterized overall and by type, frequency, seriousness, relationship to study drug, timing and severity graded according to the NCI-CTCAE v5.0; absolute values and changes in clinical laboratory parameters
  time frame: 7 days
  measure: Absorbed dose coefficients (mGy/MBq) in target organs and the effective dose coefficient (mSv/MBq)
  time frame: 1 day
  measure: Number and location of tumors identified by 68Ga-R8760 PET/CT and by anatomic images
  time frame: 1 day
  measure: Maximum standard uptake value (SUVmax) of each tumor and of source organ
  time frame: 1 day
  measure: Ratio of the tumor SUV over reference region SUV
  time frame: 1 day
  measure: Area under the plasma concentration versus time curse (AUC)
  time frame: 1 day
  measure: Maximum plasma concentration (Cmax)
  time frame: 1 day
  measure: Half-life (T1/2) of 68Ga-R8760
  time frame: 1 day
  arm group label: 68Ga-R8760 Dose Selection (Part 1)
  arm group type: Other
  arm group label: 68Ga-R8760 Expansion Cohort (Part 2)
  arm group type: Other
  intervention type: Drug
  intervention name: 68Ga-R8760 injection at pre-defined dose levels
  description: PET/CT imaging at predefined timepoints
  arm group label: 68Ga-R8760 Dose Selection (Part 1)
  intervention type: Drug
  intervention name: 68Ga-R8760 injection
  description: PET/CT imaging at a single timepoint
  arm group label: 68Ga-R8760 Expansion Cohort (Part 2)
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Istvan Molnar, MD
  phone: 201-912-6062
  email: imolnar@radionetics.com
  last name: Adina Robinson
  phone: 303-915-0344
  email: arobinson@radionetics.com
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: United States
  responsible party type: Sponsor
  mesh term: Carcinoma
  mesh term: Adrenocortical Carcinoma
  sharing ipd: No