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/NCT05980416</url>
    </required_header>
    <id_info>
      <org_study_id>ELVCAP-002-01</org_study_id>
      <nct_id>NCT05980416</nct_id>
    </id_info>
    <brief_title>Study of EO-3021 in Adult Patients With Solid Tumors Likely to Express CLDN18.2</brief_title>
    <official_title>A Phase 1 Dose Escalation and Expansion Study of EO-3021, an Anti-claudin 18.2 (CLDN18.2) Antibody Drug Conjugate, in Patients With Solid Tumors Likely to Express CLDN18.2</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Elevation Oncology</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Elevation 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>
        This study is an open-label, international, multi-center, Phase 1 study in adult patients&#xD;
        with solid tumors likely to express CLDN18.2.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 10, 2023</start_date>
    <completion_date type="Anticipated">December 2028</completion_date>
    <primary_completion_date type="Anticipated">September 2028</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>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>The incidence rate of dose limiting toxicities (DLT) during the first 21-day cycle of EO-3021 treatment</measure>
      <time_frame>The first 21-day treatment cycle for each patient enrolled in the Escalation Phase</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of patients with treatment emergent adverse events</measure>
      <time_frame>From the time of informed consent, for approximately 12 months (or earlier if the participant discontinues from the study), and through Safety Follow-up (28 days after the last dose)</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of patients with serious adverse events</measure>
      <time_frame>From the time of informed consent, for approximately 12 months (or earlier if the participant discontinues from the study), and through Safety Follow-up (28 days after the last dose)</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of patients with clinically significant changes to vital signs</measure>
      <time_frame>From the time of informed consent, for approximately 12 months (or earlier if the participant discontinues from the study), and through Safety Follow-up (28 days after the last dose</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of patients with clinically significant changes in laboratory tests</measure>
      <time_frame>From the time of informed consent, for approximately 12 months (or earlier if the participant discontinues from the study), and through Safety Follow-up (28 days after the last dose)</time_frame>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">120</enrollment>
    <condition>Pancreas Neoplasm</condition>
    <condition>Stomach Neoplasm</condition>
    <condition>Gastrointestinal Neoplasms</condition>
    <condition>Digestive System Neoplasm</condition>
    <condition>Neoplasms by Site</condition>
    <condition>Neoplasms</condition>
    <arm_group>
      <arm_group_label>Part A: Escalation</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Adult patients with select advanced unresectable or metastatic solid tumors likely to express CLDN18.2 will receive EO-3021 IV infusion at various doses every 3 weeks to determine MTD/RP2D(s).</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Part B Expansion</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients with select advanced unresectable or metastatic solid tumors will receive EO-3021 IV infusion every 3 weeks to confirm the RP2D.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>EO-3021</intervention_name>
      <description>Anti-Claudin 18.2 antibody drug conjugate</description>
      <arm_group_label>Part A: Escalation</arm_group_label>
      <arm_group_label>Part B Expansion</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Key Inclusion Criteria:&#xD;
  &#xD;
            -  Availability of tumor tissue (archived and fresh tumor biopsy, if medically feasible)&#xD;
  &#xD;
            -  Select advanced or metastatic solid tumor that is likely to express CLDN18.2 such as&#xD;
               gastric/GEJ, pancreatic and esophageal cancer&#xD;
  &#xD;
            -  ≥ 18 years of age&#xD;
  &#xD;
            -  ECOG performance status (PS) 0 or 1 at Screening&#xD;
  &#xD;
            -  Progressed on or after standard therapy, or are intolerable for available standard&#xD;
               therapy, or there is no available standard therapy&#xD;
  &#xD;
            -  Have at least one measurable extra-cranial lesion as defined by RECIST v1.1&#xD;
  &#xD;
            -  Adequate organ function&#xD;
  &#xD;
            -  Life expectancy &gt; 12 weeks&#xD;
  &#xD;
            -  Ability to understand the nature of this study, comply with protocol requirements, and&#xD;
               give written informed consent&#xD;
  &#xD;
            -  Willingness of men and women of reproductive potential to observe conventional and&#xD;
               effective birth control for the duration of treatment and for 3 months following study&#xD;
               completion&#xD;
  &#xD;
          Key Exclusion Criteria:&#xD;
  &#xD;
            -  Pregnant or breastfeeding&#xD;
  &#xD;
            -  Symptomatic or untreated brain metastases&#xD;
  &#xD;
            -  Have previously received CLDN18.2 antibody drug conjugates (ADCs) or any ADC&#xD;
               containing an auristatin payload (prior monoclonocal antibody against CLDN18.2 may be&#xD;
               eligible)&#xD;
  &#xD;
            -  Have peripheral neuropathy Grade ≥2&#xD;
  &#xD;
            -  Have history of non-infectious pneumonitis/interstitial lung disease&#xD;
  &#xD;
            -  Have diagnosis of another malignancy, or history of systemic treatment for invasive&#xD;
               cancer within last 3 years. Note: Patients with Stage I cancer who have received&#xD;
               definitive local treatment and are considered unlikely to recur are eligible.&#xD;
               Diagnosis of non-melanoma skin cancer, carcinoma in situ of the cervix or breast, or&#xD;
               noninvasive tumor does not affect eligibility&#xD;
  &#xD;
            -  Have active ocular surface disease at baseline (based on screening ophthalmic&#xD;
               examination)&#xD;
  &#xD;
            -  Have serious concurrent illness or clinically relevant active bacterial, fungal or&#xD;
               viral infection&#xD;
  &#xD;
            -  Have previous hypersensitivity to any known components of EO-3021 or history of severe&#xD;
               infusion reaction or hypersensitivity (CTCAE Grade 3 or higher) with monoclonal&#xD;
               antibody treatment&#xD;
  &#xD;
            -  Clinically significant cardiac disease, including but not limited to symptomatic&#xD;
               congestive heart failure, unstable angina, acute myocardial infarction within 6 months&#xD;
               of planned first dose, or unstable cardiac arrhythmia requiring therapy (including&#xD;
               torsades de pointes)&#xD;
  &#xD;
            -  Have history of allogenic hematopoietic stem cell transplantation or solid organ&#xD;
               transplantation with ongoing systemic immunosuppressive therapy&#xD;
  &#xD;
            -  Patients who are not appropriate candidates for participation in this clinical study&#xD;
               for any other reason as deemed by the Investigator&#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>Valerie Jansen, MD, PhD</last_name>
      <role>Study Director</role>
      <affiliation>Elevation Oncology, Inc.</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Medical Information</last_name>
      <phone>+1-716-371-1125</phone>
      <email>medinfo@elevationoncology.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Sarah Cannon Research Institute</name>
        <address>
          <city>Nashville</city>
          <state>Tennessee</state>
          <zip>37203</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Meredith Pelster, MD, MSCI</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Mary Crowley Cancer Research</name>
        <address>
          <city>Dallas</city>
          <state>Texas</state>
          <zip>75230</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Minal Barve, MD</last_name>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 31, 2023</study_first_submitted>
    <study_first_submitted_qc>July 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 8, 2023</study_first_posted>
    <last_update_submitted>August 16, 2023</last_update_submitted>
    <last_update_submitted_qc>August 16, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Gastric Cancer</keyword>
    <keyword>Gastroesophageal Junction (GEJ) Adenocarcinoma</keyword>
    <keyword>Esophageal Cancer</keyword>
    <keyword>Pancreatic Cancer</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Neoplasms</mesh_term>
      <mesh_term>Stomach Neoplasms</mesh_term>
      <mesh_term>Gastrointestinal Neoplasms</mesh_term>
      <mesh_term>Digestive System Neoplasms</mesh_term>
      <mesh_term>Neoplasms by Site</mesh_term>
      <mesh_term>Pancreatic 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/NCT05980416
  org study id: ELVCAP-002-01
  nct id: NCT05980416
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  This study is an open-label, international, multi-center, Phase 1 study in adult patients
        with solid tumors likely to express CLDN18.2.
  allocation: Non-Randomized
  intervention model: Sequential Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: The incidence rate of dose limiting toxicities (DLT) during the first 21-day cycle of EO-3021 treatment
  time frame: The first 21-day treatment cycle for each patient enrolled in the Escalation Phase
  measure: Number of patients with treatment emergent adverse events
  time frame: From the time of informed consent, for approximately 12 months (or earlier if the participant discontinues from the study), and through Safety Follow-up (28 days after the last dose)
  measure: Number of patients with serious adverse events
  time frame: From the time of informed consent, for approximately 12 months (or earlier if the participant discontinues from the study), and through Safety Follow-up (28 days after the last dose)
  measure: Number of patients with clinically significant changes to vital signs
  time frame: From the time of informed consent, for approximately 12 months (or earlier if the participant discontinues from the study), and through Safety Follow-up (28 days after the last dose
  measure: Number of patients with clinically significant changes in laboratory tests
  time frame: From the time of informed consent, for approximately 12 months (or earlier if the participant discontinues from the study), and through Safety Follow-up (28 days after the last dose)
  arm group label: Part A: Escalation
  arm group type: Experimental
  description: Adult patients with select advanced unresectable or metastatic solid tumors likely to express CLDN18.2 will receive EO-3021 IV infusion at various doses every 3 weeks to determine MTD/RP2D(s).
  arm group label: Part B Expansion
  arm group type: Experimental
  description: Patients with select advanced unresectable or metastatic solid tumors will receive EO-3021 IV infusion every 3 weeks to confirm the RP2D.
  intervention type: Drug
  intervention name: EO-3021
  description: Anti-Claudin 18.2 antibody drug conjugate
  arm group label: Part A: Escalation
  arm group label: Part B Expansion
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Valerie Jansen, MD, PhD
  role: Study Director
  affiliation: Elevation Oncology, Inc.
  last name: Medical Information
  phone: +1-716-371-1125
  email: medinfo@elevationoncology.com
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  country: United States
  responsible party type: Sponsor
  mesh term: Neoplasms
  mesh term: Stomach Neoplasms
  mesh term: Gastrointestinal Neoplasms
  mesh term: Digestive System Neoplasms
  mesh term: Neoplasms by Site
  mesh term: Pancreatic Neoplasms
  sharing ipd: No