<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/NCT03281824</url>
  </required_header>
  <id_info>
    <org_study_id>ALT-P7</org_study_id>
    <nct_id>NCT03281824</nct_id>
  </id_info>
  <brief_title>Clinical Study of ALT-P7 to Determine Safety, Tolerability and Pharmacokinetics in Breast Cancer Patients</brief_title>
  <official_title>Open-Label, Dose Increase and Phase I Study of ALT-P7 to Determine Safety, Tolerability, Pharmacokinetics for HER2 Positive Metastatic Breast Cancer Patients Who Have Progressed on Previous Trastuzumab-Based Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Alteogen, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Alteogen, Inc.</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This open-label study assessed the safety, tolerability and pharmacokinetics of&#xD;
      ALT-P7(HM2-Drug Conjugate) in patients with HER2-positive metastatic breast cancer who have&#xD;
      progressed on previous Trastuzumab-based therapy. Patients received ALT-P7(0.3 mg/kg~5.4&#xD;
      mg/kg, 7 groups) intravenously on Day 1 of each 3-week cycle.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 11, 2018</start_date>
  <completion_date type="Actual">January 15, 2021</completion_date>
  <primary_completion_date type="Actual">March 12, 2020</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>DLT test</measure>
    <time_frame>21 days after first administration</time_frame>
    <description>Determination of Maximum Tolerated Dose(MTD) and the dose level showing Dose Limiting Toxicity(DLT), or determination of Recommended Phase II Dose(RP2D) as an alternative to MTD establishment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of Treatment-Emergent Adverse Events</measure>
    <time_frame>up to 4 weeks</time_frame>
    <description>Evaluate adverse events by the Common Terminology Criteria for Adverse Event (CTCAE v4.03) classification, immune-related adverse events(irAEs)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics test</measure>
    <time_frame>up to 4 weeks</time_frame>
    <description>analyze metabolism and discover the fate of a ALT-P7 from administration up to completely eliminated from the body (Group 3(1.2 mg/kg) ~ Group 7(5.4 mg/kg))</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Immunogenicity test</measure>
    <time_frame>up to 4 weeks</time_frame>
    <description>After administration of the drug for clinical trial, the descriptive statistics of the dose group and the measurement point are calculated</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficacy test</measure>
    <time_frame>At the end of Cycle 2 (each cycle is 21 days)</time_frame>
    <description>Provide descriptive statistics for each capacity group(the number of subjects, average, standard deviation, median, minimum value, maximum value)</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">27</enrollment>
  <condition>HER2-positive Breast Cancer</condition>
  <arm_group>
    <arm_group_label>ALT-P7</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>8 groups: 0.3 mg/kg, 0.6 mg/kg, 1.2 mg/kg, 2.4 mg/kg, 3.6 mg/kg, 4.2 mg/kg, 4.5 mg/kg, 4.8 mg/kg,&#xD;
Administration: Day 1 of each 3-week cycle</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>ALT-P7 (HM2-MMAE)</intervention_name>
    <description>Antibody-Drug Conjugate</description>
    <arm_group_label>ALT-P7</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patient who voluntarily signed the agreement&#xD;
&#xD;
          2. Adult patients ≥ 19 years of age&#xD;
&#xD;
          3. Eastern Cooperative Oncology Group(ECOG) Performance status of 0 or 1&#xD;
&#xD;
          4. Appropriate organism function proven by the following laboratory test results&#xD;
&#xD;
               -  Absolute neutrophil count ≥ 1500 cells/mm³&#xD;
&#xD;
               -  Platelets ≥ 100,000 cells/mm³&#xD;
&#xD;
               -  Hemoglobin ≥ 9.0 g/dL&#xD;
&#xD;
                    -  Patients can receive red blood cell transfusions at this level.&#xD;
&#xD;
               -  Creatinine ≤ 1.5 × Upper Limit of Normal(ULN)&#xD;
&#xD;
               -  Aspartate Transaminase(AST) and Alanine Transaminase(ALT) ≤ 2.5 × ULN&#xD;
&#xD;
               -  Alkaline phosphatase ≤ 2.5 × ULN&#xD;
&#xD;
                    -  Patients with liver and/or bone metastases: AST and ALT ≤ 5 × ULN, Alkaline&#xD;
                       phosphatase ≤ 5 × ULN&#xD;
&#xD;
               -  Albumin ≥ 3.0 g/dL, Total bilirubin ≤ 2.0 mg/dL&#xD;
&#xD;
               -  International Normalized Ratio(INR) &lt; 1.5 × ULN(Except when you are on&#xD;
                  therapeutic anticoagulation therapy)&#xD;
&#xD;
          5. It should be negative in serum pregnancy test in the case of pre-menopausal women and&#xD;
             women who were menopausal for less than 12 months&#xD;
&#xD;
          6. In the case of a fertile woman, it should be negative in pregnancy test, and all men&#xD;
             and women should use effective contraceptive methods while enrolled in this study. You&#xD;
             must also agree to continue the contraception during the trial and up to 6 months&#xD;
             after the last dose of the test&#xD;
&#xD;
          7. Those who are expected to understand and observe the clinical trial plan according to&#xD;
             the tester's judgment&#xD;
&#xD;
          8. Those who voluntarily agreed to participate in this clinical trial and signed the&#xD;
             agreement&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Criteria for disease&#xD;
&#xD;
               1. Previous history of intolerance to Trastuzumab including Grade 3-4 infusion&#xD;
                  reaction or hypersensitivity&#xD;
&#xD;
               2. Previous history of permanent discontinuation of Trastuzumab due to the toxicity&#xD;
&#xD;
               3. A person who has untreated or symptomatic brain metastasis, or brain metastasis&#xD;
                  requiring radiation, surgery or corticosteroid therapy to control the brain&#xD;
                  metastases within 4 weeks of the first administration&#xD;
&#xD;
               4. Current Grade ≥ 2 (according to National Cancer Institute(NCI) Common Terminology&#xD;
                  Criteria for Adverse Events(CTCAE) v4.03 of peripheral neuropathy&#xD;
&#xD;
               5. If the toxicity of the previous treatment is not recovered to baseline level or&#xD;
                  lower than Grade 1 except for hair loss and peripheral neuropathy&#xD;
&#xD;
               6. Hypercalcemia requiring bisphosphonate therapy (&gt; 1.5 mmol/L ionized calcium or&#xD;
                  calcium &gt; 12 mg/dL or corrected serum calcium &gt; ULN) However, it is allowed if&#xD;
                  bisphosphonate has been used for bone metastasis&#xD;
&#xD;
               7. A person who has received clinical trial material, chemotherapy, hormone therapy,&#xD;
                  radiotherapy, immunotherapy or biological therapy within 3 weeks of the first&#xD;
                  administration. However, it is required a minimum of 2 weeks after surgery if&#xD;
                  stereotactic radiosurgery is performed&#xD;
&#xD;
               8. Previous history of exposure to the cumulative dose of anthracycline (Doxorubicin&#xD;
                  &gt; 360 mg/m², Epirubicin &gt; 600 mg/m²)&#xD;
&#xD;
          -  Criteria for cardio pulmonary function&#xD;
&#xD;
               1. Unstable ventricular arrhythmia requiring treatment&#xD;
&#xD;
               2. Previous history of symptomatic congestive heart failure (NYHA Class II-IV)&#xD;
&#xD;
               3. Previous history of myocardial infarction or unstable angina within 6 months&#xD;
&#xD;
               4. Cardiac troponin I ≥ 0.2 ng/mL&#xD;
&#xD;
               5. A person who has inadequate left ventricular ejection fraction(LVEF) within 3&#xD;
                  weeks of the first administration, LVEF &lt;50% by echocardiography or&#xD;
                  Multiple-gated Acquisition(MUGA)&#xD;
&#xD;
               6. A person who has severe dyspnea or pneumonia requiring continuous oxygen therapy&#xD;
&#xD;
          -  Common criteria&#xD;
&#xD;
               1. Pregnant or breastfeeding&#xD;
&#xD;
               2. A person who has undergone surgical operation or significant traumatic injury&#xD;
                  within 30 days before registration, or is expected to require surgical operation&#xD;
                  during the clinical trial&#xD;
&#xD;
               3. Previous history of malignant tumors other than breast cancer within 5 years&#xD;
                  prior to screening (patient who can participate: squamous cell and basal cell&#xD;
                  carcinoma of the skin, intraepithelial cancer of the cervix, thyroid papillary&#xD;
                  cancer, or if the tester considers that the risk of relapse is minimum(regard as&#xD;
                  full recovery) and the sponsor agrees with it)&#xD;
&#xD;
               4. A person who needs chronic corticosteroid therapy (≥ 10 mg/day prednisone or&#xD;
                  equivalent volume of other anti-inflammatory corticosteroids)&#xD;
&#xD;
               5. If the result of human immunodeficiency virus (HIV), active hepatitis B or&#xD;
                  hepatitis C is positive during screening&#xD;
&#xD;
               6. Patients with uncontrolled concomitant illnesses, including mental illness/social&#xD;
                  conditions, which may affect compliance with clinical trial procedures&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Alteogen</name>
      <address>
        <city>Daejeon</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>September 5, 2017</study_first_submitted>
  <study_first_submitted_qc>September 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 13, 2017</study_first_posted>
  <last_update_submitted>January 14, 2022</last_update_submitted>
  <last_update_submitted_qc>January 14, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 18, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>HER2 Positive Breast Cancer</keyword>
  <keyword>ALT-P7</keyword>
  <keyword>Antibody-Drug Conjugate</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
  </condition_browse>
  <!-- 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/NCT03281824
org study id: ALT-P7
nct id: NCT03281824
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This open-label study assessed the safety, tolerability and pharmacokinetics of
      ALT-P7(HM2-Drug Conjugate) in patients with HER2-positive metastatic breast cancer who have
      progressed on previous Trastuzumab-based therapy. Patients received ALT-P7(0.3 mg/kg~5.4
      mg/kg, 7 groups) intravenously on Day 1 of each 3-week cycle.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: DLT test
time frame: 21 days after first administration
description: Determination of Maximum Tolerated Dose(MTD) and the dose level showing Dose Limiting Toxicity(DLT), or determination of Recommended Phase II Dose(RP2D) as an alternative to MTD establishment
measure: Incidence of Treatment-Emergent Adverse Events
time frame: up to 4 weeks
description: Evaluate adverse events by the Common Terminology Criteria for Adverse Event (CTCAE v4.03) classification, immune-related adverse events(irAEs)
measure: Pharmacokinetics test
time frame: up to 4 weeks
description: analyze metabolism and discover the fate of a ALT-P7 from administration up to completely eliminated from the body (Group 3(1.2 mg/kg) ~ Group 7(5.4 mg/kg))
measure: Immunogenicity test
time frame: up to 4 weeks
description: After administration of the drug for clinical trial, the descriptive statistics of the dose group and the measurement point are calculated
measure: Efficacy test
time frame: At the end of Cycle 2 (each cycle is 21 days)
description: Provide descriptive statistics for each capacity group(the number of subjects, average, standard deviation, median, minimum value, maximum value)
arm group label: ALT-P7
arm group type: Experimental
description: 8 groups: 0.3 mg/kg, 0.6 mg/kg, 1.2 mg/kg, 2.4 mg/kg, 3.6 mg/kg, 4.2 mg/kg, 4.5 mg/kg, 4.8 mg/kg,
Administration: Day 1 of each 3-week cycle
intervention type: Biological
intervention name: ALT-P7 (HM2-MMAE)
description: Antibody-Drug Conjugate
arm group label: ALT-P7
criteria: 
gender: Female
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Breast Neoplasms