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/NCT06028074</url>
    </required_header>
    <id_info>
      <org_study_id>GIM122-CT01</org_study_id>
      <nct_id>NCT06028074</nct_id>
    </id_info>
    <brief_title>Safety and Tolerability Study of GIM-122 in Subjects With Advanced Solid Malignancies</brief_title>
    <official_title>A First-in-Human, Open-Label, Phase 1/2 Dose-Escalation With Enrichment and Dose-Expansion Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of GIM-122 as a Single Agent in Adult Subjects With Advanced Solid Malignancies</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Georgiamune Inc</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Georgiamune Inc</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>
        GIM-122 is a first-in-class, humanized immunoglobulin G1 kappa dual functioning monoclonal&#xD;
        antibody (DFA). This phase 1 / 2 study plans to evaluate the safety, tolerability,&#xD;
        pharmacokinetics and clinical efficacy of intravenous (IV) administration of GIM-122 in&#xD;
        adults with advanced malignancies.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a Phase 1/2, open label, first-in-human (FIH), multicenter, dose escalation study&#xD;
        with enrichments and dose expansion cohorts at RP2D, designed to evaluate the safety,&#xD;
        tolerability, PK, pharmacodynamics, and preliminary antitumor activity of GIM-122&#xD;
        administered as a single agent in adults with advanced solid malignancies. This study will be&#xD;
        conducted in 2 parts: Phase 1 or Part A (dose escalation and enrichment) and Phase 2 or Part&#xD;
        B (dose optimization and cohort expansion).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">December 2026</completion_date>
    <primary_completion_date type="Anticipated">September 2026</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>
      <intervention_model_description>Part A: Single Ascending Dose (SAD), Multiple Ascending Dose (MAD), Part B: Dose Expansion</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Dose limiting toxicities [DLT] with GIM-122</measure>
      <time_frame>18 months</time_frame>
      <description>To identify dose limiting toxicities [DLT] with GIM-122</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Maximum tolerated dose [MTD] of GIM-122</measure>
      <time_frame>18 months</time_frame>
      <description>To identify maximum tolerated dose [MTD] of GIM-122</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Recommended Phase 2 Dose [RP2D] of GIM-122</measure>
      <time_frame>18 Months</time_frame>
      <description>To identify Recommended Phase 2 Dose [RP2D] of GIM-122</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Overall response rate (ORR) -Part B of the study</measure>
      <time_frame>36 months</time_frame>
      <description>To identify overall response rate (ORR) in patients with advanced malignant tumors who are refractory/ resistant to PD-1 and PD-L1 therapy</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Anti-tumor activity of GIM-122</measure>
      <time_frame>36 months</time_frame>
      <description>To assess anti-tumor activity of GIM-122 as a single agent in patients with advanced malignant tumors who are refractory/ resistant to PD-1 and PD-L1 therapy</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Incidence and severity of AE / SAEs and tolerability</measure>
      <time_frame>36 months</time_frame>
      <description>To assess incidence and severity of AE / SAEs and tolerability assessed by CTCAE grading</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Area under the plasma concentration versus time curve (AUC)</measure>
      <time_frame>36 months</time_frame>
      <description>To preliminarily evaluate the AUC in patients with advanced malignant tumors</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Peak Plasma Concentration (Cmax)</measure>
      <time_frame>36 months</time_frame>
      <description>To preliminarily evaluate Cmax in patients with advanced malignant tumors</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time of peak plasma concentration (Tmax)</measure>
      <time_frame>36 months</time_frame>
      <description>To preliminarily evaluate Tmax in patients with advanced malignant tumors</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Overall Response Rate (ORR) - Part A of the study</measure>
      <time_frame>36 months</time_frame>
      <description>To preliminarily evaluate ORR in patients with advanced malignant tumors</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Duration of response (DOR)</measure>
      <time_frame>36 months</time_frame>
      <description>To preliminarily evaluate DOR in patients with advanced malignant tumors</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To preliminarily evaluate DOR in patients with advanced malignant tumors</measure>
      <time_frame>36 months</time_frame>
      <description>To preliminarily evaluate DCR in patients with advanced malignant tumors</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Best overall response (BOR)</measure>
      <time_frame>36 months</time_frame>
      <description>To preliminarily evaluate BOR in patients with advanced malignant tumors</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Progression-free survival (PFS)</measure>
      <time_frame>36 months</time_frame>
      <description>To preliminarily evaluate PFS in patients with advanced malignant tumors</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Overall survival (OS) rates at 12 months</measure>
      <time_frame>36 months</time_frame>
      <description>To preliminarily evaluate OS in patients with advanced malignant tumors at 12 Months</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Tumor expression of immunological markers</measure>
      <time_frame>36 months</time_frame>
      <description>To analyze tumor expression of immunological markers</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">111</enrollment>
    <condition>Advanced Solid Malignancies</condition>
    <arm_group>
      <arm_group_label>Intravenous administration of GIM-122</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>GIM-122</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>GIM122</intervention_name>
      <description>GIM-122 administered IV once every 3 weeks</description>
      <arm_group_label>Intravenous administration of GIM-122</arm_group_label>
      <other_name>GIM-122</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          General&#xD;
  &#xD;
            -  Written informed consent&#xD;
  &#xD;
            -  ECOG performance status 0-1.&#xD;
  &#xD;
            -  Laboratory assessment 28 days prior to enrollment for assessment of acceptable&#xD;
               cardiac, renal and hepatic functions&#xD;
  &#xD;
            -  Recommended Double methods of contraception 90-days post treatment Cancer Specific&#xD;
  &#xD;
            -  Histologically or cytologically confirmed locally advanced/unresectable or metastatic&#xD;
               solid tumor&#xD;
  &#xD;
            -  Received FDA approved treatment of PD-1 inhibitor or PD-L1 inhibitor for advance&#xD;
               malignant tumors and have progressed/relapsed, are refractory, or intolerant&#xD;
  &#xD;
            -  Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST),&#xD;
               version 1.1&#xD;
  &#xD;
            -  Had prior therapy with PD-1/PD-L1 inhibitors. Other checkpoint inhibitors (ie, CTLA4,&#xD;
               LAG3) are permitted if they did not lead to treatment discontinuation&#xD;
  &#xD;
            -  No other lines of therapy that are available&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          General&#xD;
  &#xD;
            -  Enrolled in any other interventional clinical trial, starting within 4 weeks of the&#xD;
               first dose of GIM-122 and throughout the duration of the study, or is receiving other&#xD;
               therapy directed at their malignancy&#xD;
  &#xD;
            -  Women who are pregnant or breastfeeding&#xD;
  &#xD;
            -  History of cardiac issues, pulmonary embolism, Active and clinically significant&#xD;
               bacterial, fungal, or viral infection ≤ 6 months prior to dosing&#xD;
  &#xD;
            -  Contraindications to the imaging assessments or other study procedures that subjects&#xD;
               will undergo or any medical or social condition that, in the opinion of the&#xD;
               investigator, might place a subject at an increased risk, affect compliance, or&#xD;
               confound safety or other clinical study data interpretation Cancer Specific&#xD;
  &#xD;
            -  Current second malignancy at other sites&#xD;
  &#xD;
            -  Leptomeningeal disease&#xD;
  &#xD;
            -  Spinal cord compression&#xD;
  &#xD;
            -  Symptomatic or new or enlarging central nervous system (CNS) metastases&#xD;
               Treatment-specific Exclusion Criteria&#xD;
  &#xD;
            -  Ongoing toxicity &gt; Grade 1 from prior therapy according to Common Terminology Criteria&#xD;
               for Adverse Events (CTCAE) v 5.0&#xD;
  &#xD;
            -  Has undergone a major surgery &lt; 1 month prior to administration of GIM-122&#xD;
  &#xD;
            -  Has received radiation therapy within 2 weeks prior to administration of GIM-122&#xD;
  &#xD;
            -  Has undergone or is anticipated to undergo organ transplantation including allogeneic&#xD;
               or autologous stem cell transplantation at any time&#xD;
  &#xD;
            -  Has received systemic anti-cancer therapy within 2 weeks and cytotoxic agents that&#xD;
               have a major delayed toxicity within 4 weeks, of the first dose of GIM-122&#xD;
  &#xD;
            -  Prior treatment with other immune modulating agents within &lt; 4 weeks prior to the&#xD;
               first dose of GIM-122.&#xD;
  &#xD;
            -  Has a diagnosis of immunodeficiency, either primary or acquired&#xD;
  &#xD;
            -  Has received treatment with systemic steroids or any form of immunosuppressive therapy&#xD;
               within 14 days prior to administration of GIM-122&#xD;
  &#xD;
            -  Has active or prior history of autoimmune disease, including ulcerative colitis and&#xD;
               Crohn's disease, or any condition that requires systemic steroids.&#xD;
  &#xD;
            -  Has a known severe intolerance to or hypersensitivity reactions to monoclonal&#xD;
               antibodies, Fc-bearing proteins, or IV immunoglobulin preparations; prior history of&#xD;
               human anti-human antibody response; known allergy to any of the study medications, or&#xD;
               excipients in the various formulations of any agent.&#xD;
  &#xD;
            -  Has received live vaccines within 30 days of study initiation (inactivated vaccines&#xD;
               are allowed; seasonal vaccines should be up to date &gt; 30 days prior to administration&#xD;
               of GIM-122).&#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>Omid Hamid, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Cedar Senai, LA</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Luma Bridge CRO</last_name>
      <phone>210-557-4291</phone>
      <email>contact@lumabridge.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>NEXT Dallas</name>
        <address>
          <city>Irving</city>
          <state>Texas</state>
          <zip>75039</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Shiraj Sen, MD, PhD</last_name>
        <phone>972-893-8800</phone>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 31, 2023</study_first_submitted>
    <study_first_submitted_qc>August 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 7, 2023</study_first_posted>
    <last_update_submitted>September 8, 2023</last_update_submitted>
    <last_update_submitted_qc>September 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 11, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>solid tumor</keyword>
    <keyword>advanced malignancies</keyword>
    <keyword>GIM-122</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Neoplasms</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/NCT06028074
  org study id: GIM122-CT01
  nct id: NCT06028074
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  GIM-122 is a first-in-class, humanized immunoglobulin G1 kappa dual functioning monoclonal
        antibody (DFA). This phase 1 / 2 study plans to evaluate the safety, tolerability,
        pharmacokinetics and clinical efficacy of intravenous (IV) administration of GIM-122 in
        adults with advanced malignancies.
  This is a Phase 1/2, open label, first-in-human (FIH), multicenter, dose escalation study
        with enrichments and dose expansion cohorts at RP2D, designed to evaluate the safety,
        tolerability, PK, pharmacodynamics, and preliminary antitumor activity of GIM-122
        administered as a single agent in adults with advanced solid malignancies. This study will be
        conducted in 2 parts: Phase 1 or Part A (dose escalation and enrichment) and Phase 2 or Part
        B (dose optimization and cohort expansion).
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: Part A: Single Ascending Dose (SAD), Multiple Ascending Dose (MAD), Part B: Dose Expansion
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Dose limiting toxicities [DLT] with GIM-122
  time frame: 18 months
  description: To identify dose limiting toxicities [DLT] with GIM-122
  measure: Maximum tolerated dose [MTD] of GIM-122
  time frame: 18 months
  description: To identify maximum tolerated dose [MTD] of GIM-122
  measure: Recommended Phase 2 Dose [RP2D] of GIM-122
  time frame: 18 Months
  description: To identify Recommended Phase 2 Dose [RP2D] of GIM-122
  measure: Overall response rate (ORR) -Part B of the study
  time frame: 36 months
  description: To identify overall response rate (ORR) in patients with advanced malignant tumors who are refractory/ resistant to PD-1 and PD-L1 therapy
  measure: Anti-tumor activity of GIM-122
  time frame: 36 months
  description: To assess anti-tumor activity of GIM-122 as a single agent in patients with advanced malignant tumors who are refractory/ resistant to PD-1 and PD-L1 therapy
  measure: Incidence and severity of AE / SAEs and tolerability
  time frame: 36 months
  description: To assess incidence and severity of AE / SAEs and tolerability assessed by CTCAE grading
  measure: Area under the plasma concentration versus time curve (AUC)
  time frame: 36 months
  description: To preliminarily evaluate the AUC in patients with advanced malignant tumors
  measure: Peak Plasma Concentration (Cmax)
  time frame: 36 months
  description: To preliminarily evaluate Cmax in patients with advanced malignant tumors
  measure: Time of peak plasma concentration (Tmax)
  time frame: 36 months
  description: To preliminarily evaluate Tmax in patients with advanced malignant tumors
  measure: Overall Response Rate (ORR) - Part A of the study
  time frame: 36 months
  description: To preliminarily evaluate ORR in patients with advanced malignant tumors
  measure: Duration of response (DOR)
  time frame: 36 months
  description: To preliminarily evaluate DOR in patients with advanced malignant tumors
  measure: To preliminarily evaluate DOR in patients with advanced malignant tumors
  time frame: 36 months
  description: To preliminarily evaluate DCR in patients with advanced malignant tumors
  measure: Best overall response (BOR)
  time frame: 36 months
  description: To preliminarily evaluate BOR in patients with advanced malignant tumors
  measure: Progression-free survival (PFS)
  time frame: 36 months
  description: To preliminarily evaluate PFS in patients with advanced malignant tumors
  measure: Overall survival (OS) rates at 12 months
  time frame: 36 months
  description: To preliminarily evaluate OS in patients with advanced malignant tumors at 12 Months
  measure: Tumor expression of immunological markers
  time frame: 36 months
  description: To analyze tumor expression of immunological markers
  arm group label: Intravenous administration of GIM-122
  arm group type: Experimental
  description: GIM-122
  intervention type: Drug
  intervention name: GIM122
  description: GIM-122 administered IV once every 3 weeks
  arm group label: Intravenous administration of GIM-122
  other name: GIM-122
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Omid Hamid, MD
  role: Principal Investigator
  affiliation: Cedar Senai, LA
  last name: Luma Bridge CRO
  phone: 210-557-4291
  email: contact@lumabridge.com
  facility: 
  contact: 
  country: United States
  responsible party type: Sponsor
  mesh term: Neoplasms
  sharing ipd: No