<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/NCT03272256</url>
  </required_header>
  <id_info>
    <org_study_id>IM_IM156-01</org_study_id>
    <nct_id>NCT03272256</nct_id>
  </id_info>
  <brief_title>Phase 1 Study of IM156 in Patients With Advanced Solid Tumor and Lymphoma</brief_title>
  <official_title>A Multi Center, Open-label, Phase 1 Clinical Trial to Evaluate the Safety, Tolerability, and Preliminary Efficacy of IM156 in Patients With Advanced Solid Tumors and Lymphoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>ImmunoMet Therapeutics, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>ImmunoMet Therapeutics, Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main purpose of first-in-human IM156 study is to evaluate the safety and tolerability,&#xD;
      and to determine the maximum tolerated dose and recommended phase 2 dose of IM156.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 9, 2017</start_date>
  <completion_date type="Actual">July 28, 2020</completion_date>
  <primary_completion_date type="Actual">December 2, 2019</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>Sequential Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Dose Limiting Toxicity (DLT)</measure>
    <time_frame>4 weeks</time_frame>
    <description>Evaluate the safety and tolerability to determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Maximum plasma concentration (Cmax)</measure>
    <time_frame>4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Cmax (Tmax)</measure>
    <time_frame>4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the curve (AUC)</measure>
    <time_frame>4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma half life (T1/2)</measure>
    <time_frame>4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Volume of distribution (V/F)</measure>
    <time_frame>4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma Clearance (CL/F)</measure>
    <time_frame>4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Exploratory Surrogate Biomarker</measure>
    <time_frame>2 weeks</time_frame>
    <description>Explore potential surrogate biomarkers in peripheral blood mononuclear cells (PBMC).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Preliminary tumor response</measure>
    <time_frame>Every 8 weeks up to end of treatment (EOT)</time_frame>
    <description>Assess objective tumor response and progression based on the Response Evaluation Criteria for Solid Tumor (RECIST) v1.1 [for patients with recurrent glioblastoma, the Response Assessment in Neuro-Oncology (RANO) guideline is applied].</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">22</enrollment>
  <condition>Advanced Solid Tumor</condition>
  <arm_group>
    <arm_group_label>IM156, Dose escalation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>IM156</intervention_name>
    <description>Sequential 3+3 design.</description>
    <arm_group_label>IM156, Dose escalation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Aged at least 19 years old.&#xD;
&#xD;
          2. Patients histologically or cytologically diagnosed with advanced solid tumor.&#xD;
&#xD;
          3. Patients for whom no standard therapies are available or who have failed in the&#xD;
             existing conventional therapies.&#xD;
&#xD;
          4. Patients with a measurable or evaluable lesion by the RECIST v1.1 [for patients with&#xD;
             recurrent glioblastoma, the RANO guideline is applied].&#xD;
&#xD;
          5. Patients with the Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or&#xD;
             2.&#xD;
&#xD;
          6. Patients with the adequate function of bone marrow, kidney and liver as follows.&#xD;
&#xD;
             ① Absolute Neutrophil Count ≥ 1,500/mm³, Platelet ≥ 100,000/mm³, Hemoglobin ≥ 9.0 g/dL&#xD;
             (In case of hemoglobin &lt; 9.0 g/dL, the patient can be enrolled if the value is&#xD;
             reversed to ≥ 9.0 g/dL. However, blood transfusion to meet this criterion within 1&#xD;
             week is not allowed.)&#xD;
&#xD;
             ② Serum creatinine ≤ 1.5 X upper limit of normal (ULN)&#xD;
&#xD;
             ③ Total bilirubin ≤ 1.5 X UNL, AST, ALT ≤ 3 ×ULN (for patients with liver disease ≤ 5&#xD;
             ×ULN)&#xD;
&#xD;
             ④ Fasting serum glucose ≤ 160 mg/dL&#xD;
&#xD;
          7. Patients with the life expectancy ≥ 12 weeks.&#xD;
&#xD;
          8. Patients who have agreed to use acceptable methods for contraception during the study&#xD;
             treatment period.&#xD;
&#xD;
             (e.g.: sterilization of the patient and his/her partner, intrauterine device of the&#xD;
             partner, barrier contraception, combination with diaphragm or condom)&#xD;
&#xD;
          9. Patients who have voluntarily signed an informed consent to participate in this&#xD;
             clinical study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with a history of hypersensitivity to the active ingredient or any component&#xD;
             of the investigational product or biguanides.&#xD;
&#xD;
          2. Patients with a current evidence of diabetes mellitus who are currently being treated&#xD;
             with another biguanide (e.g., metformin)&#xD;
&#xD;
          3. Patients with a history of serious gastrointestinal bleeding within 6 weeks prior to&#xD;
             screening or patients with any disease possibly affecting the absorption of oral&#xD;
             agents. (malabsorption syndrome, hemorrhagic gastric ulcer, etc.)&#xD;
&#xD;
          4. At the time of screening,&#xD;
&#xD;
               -  For patients who underwent major surgery, at least 4 weeks have not elapsed after&#xD;
                  surgery.&#xD;
&#xD;
               -  For patients who underwent radiotherapy, at least 3 weeks have not elapsed from&#xD;
                  the last treatment day.&#xD;
&#xD;
               -  For patients who underwent chemotherapy, at least 3 weeks have not elapsed from&#xD;
                  the last treatment day. (6 weeks for nitrosurea compounds).&#xD;
&#xD;
               -  For patients treated with biologic agents including hormone therapy, at least 5&#xD;
                  half-lives or 3 weeks, whichever is shorter.&#xD;
&#xD;
          5. Patients who have not been recovered from the toxicities to grade 1 of the therapy&#xD;
             received prior to screening.&#xD;
&#xD;
          6. Pregnant women or nursing mothers.&#xD;
&#xD;
          7. Patients who were administered another investigational product within 3 weeks prior to&#xD;
             screening.&#xD;
&#xD;
          8. Patients with uncontrolled metastasis to the central nervous system. However, patients&#xD;
             with treated and stable brain metastases (stable at least for 30 days on radiology&#xD;
             imaging) are allowed to enroll.&#xD;
&#xD;
          9. Patients with suspected serious infectious diseases, intestinal paralysis, bowel&#xD;
             obstruction, interstitial pneumonia, or pulmonary fibrosis.&#xD;
&#xD;
         10. Patients with a history of psychiatric disorders likely to threaten the compliance&#xD;
             with this protocol.&#xD;
&#xD;
         11. Patients with a history of alcohol or drug abuse within 12 weeks prior to screening.&#xD;
&#xD;
         12. Human Immunodeficiency Virus (HIV) infection or active hepatitis B or C. Patients with&#xD;
             no detectable viral load could be enrolled.&#xD;
&#xD;
         13. Patients with severe traumatism.&#xD;
&#xD;
         14. Patients with any clinically significant abnormal intestinal findings that may&#xD;
             interfere with the administration, passage, or absorption of the investigational&#xD;
             product, which makes the patients unable to orally take the tablet form of drugs.&#xD;
&#xD;
         15. Patients with severe cardiac disorders (e.g. myocardial infarction, congestive heart&#xD;
             failure, arrhythmia showing dramatic change in electrocardiogram (ECG), severe or&#xD;
             unstable angina, other serious cardiac disorders) or patients with comorbidities of&#xD;
             other serious internal disorders (e.g. uncontrolled diabetes mellitus, chronic&#xD;
             obstructive pulmonary disorder, renal failure, etc.) on investigator's judgment.&#xD;
&#xD;
         16. Patients who are otherwise considered to be ineligible for this study on&#xD;
             investigator's judgment.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sun Young Rha, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of oncology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHA Bundang Medical Center</name>
      <address>
        <city>Seongnam-si</city>
        <state>Gyeonggi-do</state>
        <zip>13496</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asan Medical Center</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yonsei University Severance Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>August 29, 2017</study_first_submitted>
  <study_first_submitted_qc>September 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 5, 2017</study_first_posted>
  <last_update_submitted>October 15, 2020</last_update_submitted>
  <last_update_submitted_qc>October 15, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 19, 2020</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>Lymphoma</mesh_term>
    <mesh_term>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/NCT03272256
org study id: IM_IM156-01
nct id: NCT03272256
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The main purpose of first-in-human IM156 study is to evaluate the safety and tolerability,
      and to determine the maximum tolerated dose and recommended phase 2 dose of IM156.
allocation: N/A
intervention model: Sequential Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Dose Limiting Toxicity (DLT)
time frame: 4 weeks
description: Evaluate the safety and tolerability to determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D)
measure: Maximum plasma concentration (Cmax)
time frame: 4 weeks
measure: Time to Cmax (Tmax)
time frame: 4 weeks
measure: Area under the curve (AUC)
time frame: 4 weeks
measure: Plasma half life (T1/2)
time frame: 4 weeks
measure: Volume of distribution (V/F)
time frame: 4 weeks
measure: Plasma Clearance (CL/F)
time frame: 4 weeks
measure: Exploratory Surrogate Biomarker
time frame: 2 weeks
description: Explore potential surrogate biomarkers in peripheral blood mononuclear cells (PBMC).
measure: Preliminary tumor response
time frame: Every 8 weeks up to end of treatment (EOT)
description: Assess objective tumor response and progression based on the Response Evaluation Criteria for Solid Tumor (RECIST) v1.1 [for patients with recurrent glioblastoma, the Response Assessment in Neuro-Oncology (RANO) guideline is applied].
arm group label: IM156, Dose escalation
arm group type: Experimental
intervention type: Drug
intervention name: IM156
description: Sequential 3+3 design.
arm group label: IM156, Dose escalation
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: Sun Young Rha, MD, PhD
role: Principal Investigator
affiliation: Department of oncology
facility: 
facility: 
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Lymphoma
mesh term: Neoplasms