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/NCT05969041</url>
    </required_header>
    <id_info>
      <org_study_id>MTX-TROP2-302</org_study_id>
      <nct_id>NCT05969041</nct_id>
    </id_info>
    <brief_title>Study of MT-302 in Adults With Advanced or Metastatic Epithelial Tumors</brief_title>
    <acronym>MYE Symphony</acronym>
    <official_title>A Phase 1, Open-Label, First-in-Human, Dose Escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of MT-302 in Adults With Advanced or Metastatic Epithelial Tumors</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Myeloid Therapeutics</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Myeloid Therapeutics</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>
        This is a multicenter, open-label, Phase 1 first-in-human study to assess the safety,&#xD;
        tolerability, and define the RP2D of MT-302 in participants with advanced epithelial cancer.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The study has 4 Cohorts. Each Cohort has 4 Cycles. For Cohorts 1-3, the dosing regimen will&#xD;
        be every 14 days for 3 doses, followed by administration once every 28 days for three doses.&#xD;
        For Cohort 4, the dosing regimen will be modified. Participants will receive one dose of&#xD;
        MT-302 every week for 3 doses, followed by administration once every 28 days for three&#xD;
        additional doses.&#xD;
  &#xD;
        A Safety Review Committee (SRC) will provide oversight for this study. The primary&#xD;
        responsibility of the SRC is to safeguard study participants by reviewing and assessing the&#xD;
        clinical safety data being collected during the conduct of the study.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">August 15, 2023</start_date>
    <completion_date type="Anticipated">August 31, 2028</completion_date>
    <primary_completion_date type="Anticipated">August 31, 2027</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>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>To evaluate the safety and tolerability of MT-302 through incidence of Adverse Events</measure>
      <time_frame>Up to Week 20</time_frame>
      <description>Adverse Events will be graded according to the NCI-CTCAE, version 5.0</description>
    </primary_outcome>
    <primary_outcome>
      <measure>To establish the maximum tolerated dose (MTD)</measure>
      <time_frame>Up to Week 20</time_frame>
      <description>based on dose limiting toxicities (DLTs) and the recommended Phase 2 dose (RP2D)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>To further characterize the safety of MT-302 through incidence of Adverse Events</measure>
      <time_frame>Up to Week 20</time_frame>
      <description>Adverse Events will be graded according to the NCI-CTCAE, version 5.0</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To assess the pharmacokinetics (PK) of MT-302</measure>
      <time_frame>Up to Week 20</time_frame>
      <description>PK parameter: Plasma concentrations</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To assess the pharmacokinetics (PK) of MT-302</measure>
      <time_frame>Up to Week 20</time_frame>
      <description>PK parameter: Area under curve (AUC0-last, AUC 0-∞)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To assess the pharmacokinetics (PK) of MT-302</measure>
      <time_frame>Up to Week 20</time_frame>
      <description>PK parameter: Time of maximum observed plasma concentration (tmax)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To assess the pharmacokinetics (PK) of MT-302</measure>
      <time_frame>Up to Week 20</time_frame>
      <description>PK parameter: Apparent terminal Half-life (t1/2)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To assess the pharmacokinetics (PK) of MT-302</measure>
      <time_frame>Up to Week 20</time_frame>
      <description>PK parameter: Plasma Clearance (CL)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To assess the pharmacokinetics (PK) of MT-302</measure>
      <time_frame>Up to Week 20</time_frame>
      <description>PK parameter: Volume of Distribution (Vd)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To assess the pharmacokinetics (PK) of MT-302</measure>
      <time_frame>Up to Week 20</time_frame>
      <description>PK parameter:Mean residence time (MRT)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To assess the pharmacokinetics (PK) of MT-302</measure>
      <time_frame>Up to Week 20</time_frame>
      <description>PK parameter: terminal rate constant ( λz)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Determine rate of ICANS</measure>
      <time_frame>Up to Week 20</time_frame>
      <description>For grading of potential immune effector cell-associated neurotoxicity syndrome (ICANS), use of the 10-point immune effector cell-associated encephalopathy (ICE) screening tool</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Determine rate of Grade 3-5 CRS</measure>
      <time_frame>Up to Week 20</time_frame>
      <description>ASCO CRS Grading</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">48</enrollment>
    <condition>Epithelial Tumors, Malignant</condition>
    <arm_group>
      <arm_group_label>A (MT-302)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive MT-302 through intravenous infusion.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>MT-302 (A)</intervention_name>
      <description>MT-302 is an investigational drug</description>
      <arm_group_label>A (MT-302)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Adults age ≥ 18 inclusive at the time the Informed Consent Form (ICF) is signed.&#xD;
  &#xD;
            2. Histologically proven, metastatic or advanced epithelial cancer including the&#xD;
               following cancer types:&#xD;
  &#xD;
                 1. Urothelial&#xD;
  &#xD;
                 2. Cervical&#xD;
  &#xD;
                 3. Ovarian epithelial&#xD;
  &#xD;
                 4. Triple-negative breast&#xD;
  &#xD;
                 5. HR+/HER2- breast&#xD;
  &#xD;
                 6. Pancreatic ductal adenocarcinoma&#xD;
  &#xD;
                 7. Gastric adenocarcinoma&#xD;
  &#xD;
                 8. Esophageal carcinoma&#xD;
  &#xD;
                 9. Non-small cell lung&#xD;
  &#xD;
                10. Colorectal&#xD;
  &#xD;
            3. Progressive disease at baseline, refractory or relapsed to standard of care or who&#xD;
               have declined standard therapy.&#xD;
  &#xD;
            4. Measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST)&#xD;
               criteria v 1.1.&#xD;
  &#xD;
            5. Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1.&#xD;
  &#xD;
            6. Life expectancy of &gt; 12 weeks.&#xD;
  &#xD;
            7. Echocardiogram (ECHO) or multiple gated acquisition scan showing an ejection fraction&#xD;
               greater than or equal to 50%.&#xD;
  &#xD;
            8. Electrocardiogram (ECG) showing no clinically significant abnormality at Screening or&#xD;
               showing an average QTc interval &lt; 450 msec in males and &lt; 470 msec in females (&lt; 480&#xD;
               msec for participants with bundle branch block). Either Fridericia's or Bazett's&#xD;
               formula may be used to correct the QT interval.&#xD;
  &#xD;
            9. Oxygen saturation of greater than or equal to 90% on room air measured by pulse&#xD;
               oximetry.&#xD;
  &#xD;
           10. Adequate organ function as defined by laboratory values at Screening.&#xD;
  &#xD;
           11. Willing and able to provide written informed consent.&#xD;
  &#xD;
           12. Willing to perform and comply with all study procedures including undergoing&#xD;
               study-related biopsies and attending clinic visits as scheduled.&#xD;
  &#xD;
           13. Men must abstain from sperm donation during study treatment or for 4 months following&#xD;
               last dose of study treatment.&#xD;
  &#xD;
           14. Men and WOCBP must be willing to practice a highly effective method of contraception.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Known active CNS metastasis and/or carcinomatous meningitis. Participants with&#xD;
               previously treated brain metastases may participate provided they are radiologically&#xD;
               stable, (ie, without evidence of progression for at least 4 weeks by repeat imaging),&#xD;
               clinically stable, and without requirement of steroid treatment for at least 14 days&#xD;
               prior to the first dose of study intervention.&#xD;
  &#xD;
            2. Pregnant or nursing women.&#xD;
  &#xD;
            3. Must be &gt; 28 days beyond major surgery, including hepatectomy or joint replacement.&#xD;
  &#xD;
            4. Prior allogeneic bone marrow transplantation or solid organ transplant.&#xD;
  &#xD;
            5. Spinal cord compression not definitively treated with surgery and/or radiation.&#xD;
  &#xD;
            6. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent&#xD;
               drainage procedures.&#xD;
  &#xD;
            7. Any acute illness including fever (&gt; 100.4° F or &gt; 38° C) within 7 days prior to Day 1&#xD;
  &#xD;
            8. Active systemic bacterial, fungal, or viral infection within 7 days prior to Day 1.&#xD;
               Participant cannot have tested positive for COVID-19 within 7 days prior to Day 1.&#xD;
  &#xD;
            9. Active infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV),&#xD;
               hepatitis C virus (HCV).&#xD;
  &#xD;
           10. Other primary malignancies, except:&#xD;
  &#xD;
                 1. Adequately treated basal cell or squamous cell carcinoma&#xD;
  &#xD;
                 2. In situ carcinoma of the cervix or bladder, treated curatively and without&#xD;
                    evidence of recurrence for at least 2 years prior to the study, or&#xD;
  &#xD;
                 3. A primary malignancy which has been completely resected and in complete remission&#xD;
                    for at least 2 years&#xD;
  &#xD;
           11. History of (noninfectious) pneumonitis/interstitial lung disease that required&#xD;
               steroids or has current pneumonitis/interstitial lung disease.&#xD;
  &#xD;
           12. Prior grade &gt; 3 immune-related AEs such as pneumonitis, colitis, hepatitis, nephritis;&#xD;
               prior dermatitis and endocrinopathies are allowed provided corticosteroids are no&#xD;
               longer required and endocrine-replacement therapy is stable and discontinued from&#xD;
               prior therapy.&#xD;
  &#xD;
           13. Active autoimmune disease not related to prior therapy for primary malignancy that has&#xD;
               required systemic therapy in the last 1 year.&#xD;
  &#xD;
           14. History of symptomatic congestive heart failure (New York Heart Association classes&#xD;
               II-IV) or serious active arrhythmias or other clinically significant cardiac disease&#xD;
               within 12 months of enrollment.&#xD;
  &#xD;
           15. Toxicity from previous anti-cancer therapy defined as toxicities (other than alopecia,&#xD;
               or laboratory values listed above) not yet resolved to NCI CTCAE v5.0 Grade ≤ 1 or&#xD;
               baseline. Participants with chronic Grade 2 toxicities (eg, peripheral neuropathy,&#xD;
               laboratory values) may be eligible per the discretion of the Investigator and Medical&#xD;
               Monitor.&#xD;
  &#xD;
           16. Has received:&#xD;
  &#xD;
                 1. Radiotherapy within 2 weeks of first administration of MT-302&#xD;
  &#xD;
                 2. Cytotoxic chemotherapy for the treatment within 21 days or 5 half-lives,&#xD;
                    whichever is shorter, of administration of MT-302&#xD;
  &#xD;
                 3. Immune therapy for primary malignancy (eg, monoclonal antibody therapy,&#xD;
                    checkpoint inhibitors) within 21 days or 5 half-lives, whichever is shorter of&#xD;
                    first administration of MT-302&#xD;
  &#xD;
                 4. Anti-cancer vaccine within 12 weeks of first administration of MT-302&#xD;
  &#xD;
                 5. COVID-19 mRNA vaccine within 6 weeks of first administration of MT-302&#xD;
  &#xD;
           17. Has received a live vaccine ≤ 6 weeks prior to first administration of MT-302&#xD;
  &#xD;
           18. Has received packed red blood cells or platelet transfusion within 2 weeks prior to&#xD;
               first administration of MT-302&#xD;
  &#xD;
           19. History of an allergic reaction to any of the excipients&#xD;
  &#xD;
           20. Enrollment in another interventional clinical trial within 21 days or 5 half-lives of&#xD;
               the drug, whichever is shorter, of first administration of MT-302&#xD;
  &#xD;
           21. Any other condition that, in the opinion of the Investigator, would make the&#xD;
               participant unsuitable for the study or unable to comply with the study requirements.&#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>Michele Gerber, MD, MPH</last_name>
      <role>Study Director</role>
      <affiliation>Myeloid Therapeutics</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Shinam Garg</last_name>
      <phone>+61 2 9171 3260</phone>
      <email>Shinam.garg@novotech-cro.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Michele Gerber</last_name>
      <phone>+1 734 276-2179</phone>
      <email>mgerber@myeloidtx.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Scientia Clinical Research Ltd</name>
        <address>
          <city>Randwick</city>
          <state>New South Wales</state>
          <zip>2031</zip>
          <country>Australia</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Charlotte Lemech</last_name>
      </contact>
      <investigator>
        <last_name>Charlotte Lemech</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Australia</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 6, 2023</study_first_submitted>
    <study_first_submitted_qc>July 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>August 1, 2023</last_update_submitted>
    <last_update_submitted_qc>August 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 3, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Urothelial cancer</keyword>
    <keyword>Cervical cancer</keyword>
    <keyword>Ovarian epithelial</keyword>
    <keyword>Triple-negative breast cancer</keyword>
    <keyword>HR+/HER2- breast cancer</keyword>
    <keyword>Pancreatic ductal adenocarcinoma</keyword>
    <keyword>Gastric adenocarcinoma</keyword>
    <keyword>Esophageal carcinoma</keyword>
    <keyword>Non-small cell lung cancer</keyword>
    <keyword>Colorectal cancer</keyword>
    <keyword>TROP-2 expressing tumors</keyword>
    <keyword>MT-302</keyword>
    <keyword>Anti-TROP-2 chimeric antigen receptor</keyword>
    <keyword>Myeloid cells</keyword>
    <keyword>Monocytes</keyword>
    <keyword>Chimeric Antigen Receptor (CAR)</keyword>
    <keyword>mRNA</keyword>
    <keyword>Lipid nanoparticle (LNP)</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Neoplasms, Glandular and Epithelial</mesh_term>
      <mesh_term>Carcinoma</mesh_term>
    </condition_browse>
    <!-- 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/NCT05969041
  org study id: MTX-TROP2-302
  nct id: NCT05969041
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  This is a multicenter, open-label, Phase 1 first-in-human study to assess the safety,
        tolerability, and define the RP2D of MT-302 in participants with advanced epithelial cancer.
  The study has 4 Cohorts. Each Cohort has 4 Cycles. For Cohorts 1-3, the dosing regimen will
        be every 14 days for 3 doses, followed by administration once every 28 days for three doses.
        For Cohort 4, the dosing regimen will be modified. Participants will receive one dose of
        MT-302 every week for 3 doses, followed by administration once every 28 days for three
        additional doses.
  
        A Safety Review Committee (SRC) will provide oversight for this study. The primary
        responsibility of the SRC is to safeguard study participants by reviewing and assessing the
        clinical safety data being collected during the conduct of the study.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: To evaluate the safety and tolerability of MT-302 through incidence of Adverse Events
  time frame: Up to Week 20
  description: Adverse Events will be graded according to the NCI-CTCAE, version 5.0
  measure: To establish the maximum tolerated dose (MTD)
  time frame: Up to Week 20
  description: based on dose limiting toxicities (DLTs) and the recommended Phase 2 dose (RP2D)
  measure: To further characterize the safety of MT-302 through incidence of Adverse Events
  time frame: Up to Week 20
  description: Adverse Events will be graded according to the NCI-CTCAE, version 5.0
  measure: To assess the pharmacokinetics (PK) of MT-302
  time frame: Up to Week 20
  description: PK parameter: Plasma concentrations
  measure: To assess the pharmacokinetics (PK) of MT-302
  time frame: Up to Week 20
  description: PK parameter: Area under curve (AUC0-last, AUC 0-∞)
  measure: To assess the pharmacokinetics (PK) of MT-302
  time frame: Up to Week 20
  description: PK parameter: Time of maximum observed plasma concentration (tmax)
  measure: To assess the pharmacokinetics (PK) of MT-302
  time frame: Up to Week 20
  description: PK parameter: Apparent terminal Half-life (t1/2)
  measure: To assess the pharmacokinetics (PK) of MT-302
  time frame: Up to Week 20
  description: PK parameter: Plasma Clearance (CL)
  measure: To assess the pharmacokinetics (PK) of MT-302
  time frame: Up to Week 20
  description: PK parameter: Volume of Distribution (Vd)
  measure: To assess the pharmacokinetics (PK) of MT-302
  time frame: Up to Week 20
  description: PK parameter:Mean residence time (MRT)
  measure: To assess the pharmacokinetics (PK) of MT-302
  time frame: Up to Week 20
  description: PK parameter: terminal rate constant ( λz)
  measure: Determine rate of ICANS
  time frame: Up to Week 20
  description: For grading of potential immune effector cell-associated neurotoxicity syndrome (ICANS), use of the 10-point immune effector cell-associated encephalopathy (ICE) screening tool
  measure: Determine rate of Grade 3-5 CRS
  time frame: Up to Week 20
  description: ASCO CRS Grading
  arm group label: A (MT-302)
  arm group type: Experimental
  description: Participants will receive MT-302 through intravenous infusion.
  intervention type: Drug
  intervention name: MT-302 (A)
  description: MT-302 is an investigational drug
  arm group label: A (MT-302)
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Michele Gerber, MD, MPH
  role: Study Director
  affiliation: Myeloid Therapeutics
  last name: Shinam Garg
  phone: +61 2 9171 3260
  email: Shinam.garg@novotech-cro.com
  last name: Michele Gerber
  phone: +1 734 276-2179
  email: mgerber@myeloidtx.com
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: Australia
  responsible party type: Sponsor
  mesh term: Neoplasms, Glandular and Epithelial
  mesh term: Carcinoma