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/NCT06034275</url>
    </required_header>
    <id_info>
      <org_study_id>VNC-943-101</org_study_id>
      <nct_id>NCT06034275</nct_id>
    </id_info>
    <brief_title>Phase 1 Dose Escalation Study for VIP943 Subjects With Advanced CD123+ Hematologic Malignancies</brief_title>
    <official_title>An Open-label, Multicenter Phase 1 Study to Characterize Safety, Tolerability, Preliminary Antitumor Activity, Pharmacokinetics, and Pharmacodynamics of VIP943 Monotherapy in Subjects With Advanced CD123+ Hematologic Malignancies</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Vincerx Pharma, Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Vincerx Pharma, 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>
        Dose Escalation - Determine the maximum tolerated dose (MTD), if possible, or minimum optimal&#xD;
        biologic dose (OBD), and evaluate the safety and tolerability of VIP943 in subjects with&#xD;
        advanced CD123+ hematologic malignancies&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Relapsed or refractory AML, MDS, or B-ALL subjects who are CD123 positive. Subjects must have&#xD;
        exhausted all available standard therapies or be deemed ineligible for potential available&#xD;
        therapies.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 8, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">May 30, 2025</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>
      <intervention_model_description>Sequential Assignment</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Incidence of DLT (Dose limit toxicity) of VIP943</measure>
      <time_frame>Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 28 days</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Response rate to VIP943 as assessed by investigators using disease-specific response criteria</measure>
      <time_frame>Cycle 1 Day 1 up to 30 days after the last dose, where each cycle is up to 28 days (up to approximately 10 months)</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Maximum observed drug concentration in measured matrix after single dose administration (Cmax) of VIP943</measure>
      <time_frame>Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 28 days</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Area under the concentration versus time curve from zero to infinity after single (first) dose (AUC) of VIP943</measure>
      <time_frame>Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 28 days</time_frame>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">36</enrollment>
    <condition>Acute Myeloid Leukemia</condition>
    <condition>B-cell Acute Lymphoblastic Leukemia</condition>
    <condition>High-risk Myelodysplastic Syndrome</condition>
    <arm_group>
      <arm_group_label>Dose Escalation of VIP943</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Investigating VIP943 in dose escalation cohorts in subjects with AML, MDS, and B-ALL with CD123 expression</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>VIP943</intervention_name>
      <description>VIP943 will be administered by IV Infusion weekly</description>
      <arm_group_label>Dose Escalation of VIP943</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Histologically confirmed AML, B-ALL or MDS. Subjects must have exhausted all available&#xD;
               standard therapies or be deemed ineligible for potential available therapies.&#xD;
  &#xD;
            -  Evidence of ≥5% bone marrow or blood blasts (acute leukemia) or ≥5% bone marrow or&#xD;
               blood myeloblasts (MDS) to allow for assessment of drug activity.&#xD;
  &#xD;
            -  Evidence of CD123 expression from a local laboratory.&#xD;
  &#xD;
            -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Known central nervous system (CNS) metastases and/or carcinomatous meningitis.&#xD;
  &#xD;
            -  Clinically significant cardiac disease including congestive heart failure &gt; New York&#xD;
               Heart Association (NYHA) Class II), evidence for coronary artery disease (eg, unstable&#xD;
               angina (anginal symptoms at rest) or new-onset angina (within the last 6 months or&#xD;
               myocardial infarction within the past 6 months before first dose.&#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>Vincerx Study Director</last_name>
      <role>Study Director</role>
      <affiliation>Vincerx Pharma, Inc.</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Vincerx Clinical Trials Contact</last_name>
      <phone>16508006676</phone>
      <email>clinicaltrials@vincerx.com</email>
    </overall_contact>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 5, 2023</study_first_submitted>
    <study_first_submitted_qc>September 5, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 5, 2023</last_update_submitted>
    <last_update_submitted_qc>September 5, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>ADC</keyword>
    <keyword>Hematologic Malignancies</keyword>
    <keyword>Leukemia</keyword>
    <keyword>CD123</keyword>
    <keyword>B-ALL</keyword>
    <keyword>AML</keyword>
    <keyword>MDS</keyword>
    <keyword>Relapsed/ Refractory</keyword>
    <keyword>Hematologic Diseases</keyword>
    <keyword>Bone Marrow Diseases</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Leukemia</mesh_term>
      <mesh_term>Neoplasms</mesh_term>
      <mesh_term>Precursor Cell Lymphoblastic Leukemia-Lymphoma</mesh_term>
      <mesh_term>Hematologic Neoplasms</mesh_term>
      <mesh_term>Myelodysplastic Syndromes</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/NCT06034275
  org study id: VNC-943-101
  nct id: NCT06034275
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  Dose Escalation - Determine the maximum tolerated dose (MTD), if possible, or minimum optimal
        biologic dose (OBD), and evaluate the safety and tolerability of VIP943 in subjects with
        advanced CD123+ hematologic malignancies
  Relapsed or refractory AML, MDS, or B-ALL subjects who are CD123 positive. Subjects must have
        exhausted all available standard therapies or be deemed ineligible for potential available
        therapies.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: Sequential Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Incidence of DLT (Dose limit toxicity) of VIP943
  time frame: Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 28 days
  measure: Response rate to VIP943 as assessed by investigators using disease-specific response criteria
  time frame: Cycle 1 Day 1 up to 30 days after the last dose, where each cycle is up to 28 days (up to approximately 10 months)
  measure: Maximum observed drug concentration in measured matrix after single dose administration (Cmax) of VIP943
  time frame: Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 28 days
  measure: Area under the concentration versus time curve from zero to infinity after single (first) dose (AUC) of VIP943
  time frame: Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 28 days
  arm group label: Dose Escalation of VIP943
  arm group type: Experimental
  description: Investigating VIP943 in dose escalation cohorts in subjects with AML, MDS, and B-ALL with CD123 expression
  intervention type: Drug
  intervention name: VIP943
  description: VIP943 will be administered by IV Infusion weekly
  arm group label: Dose Escalation of VIP943
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Vincerx Study Director
  role: Study Director
  affiliation: Vincerx Pharma, Inc.
  last name: Vincerx Clinical Trials Contact
  phone: 16508006676
  email: clinicaltrials@vincerx.com
  responsible party type: Sponsor
  mesh term: Leukemia
  mesh term: Neoplasms
  mesh term: Precursor Cell Lymphoblastic Leukemia-Lymphoma
  mesh term: Hematologic Neoplasms
  mesh term: Myelodysplastic Syndromes
  sharing ipd: No