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/NCT06036121</url>
    </required_header>
    <id_info>
      <org_study_id>ADRX-0706-001</org_study_id>
      <nct_id>NCT06036121</nct_id>
    </id_info>
    <brief_title>A Study of ADRX-0706 in Select Advanced Solid Tumors</brief_title>
    <official_title>A Phase 1a/b Study of ADRX-0706 in Subjects With Select Advanced Solid Tumors</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Adcentrx Therapeutics</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Adcentrx Therapeutics</source>
    <oversight_info>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The primary purpose of this study is to assess the safety, tolerability, and&#xD;
        pharmacokinetics, and to identify the optimal dose of ADRX-0706 in patients with select&#xD;
        advanced solid tumors.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a 2 part study. The Phase 1a will consist of a dose escalation of ADRX-0706 to&#xD;
        evaluate initial safety and tolerability in patients with select advanced solid tumors, and&#xD;
        to identify the recommended dose to be used in the Phase 1b. The Phase 1b will further&#xD;
        evaluate the safety and tolerability, as well as preliminary efficacy, and identify the&#xD;
        optimal dose of ADRX-0706 in 3 disease-specific expansion cohorts.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>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 2025</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>Incidence of adverse events</measure>
      <time_frame>Until study completion (estimated 3 years)</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Measurement of maximum plasma concentration (Cmax) of ADRX-0706</measure>
      <time_frame>Until study completion (estimated 3 years)</time_frame>
      <description>Measured from pharmacokinetic (PK) blood samples</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Measurement of trough concentration (Ctrough) of ADRX-0706</measure>
      <time_frame>Until study completion (estimated 3 years)</time_frame>
      <description>Measured from PK blood samples</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Measurement of area under the serum concentration-time curve (AUC) of ADRX-0706</measure>
      <time_frame>Until study completion (estimated 3 years)</time_frame>
      <description>Measured from PK blood samples</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Measurement of terminal half-life (t1/2) of ADRX-0706</measure>
      <time_frame>Until study completion (estimated 3 years)</time_frame>
      <description>Measured from PK blood samples</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Measurement of systemic clearance (CL) of ADRX-0706</measure>
      <time_frame>Until study completion (estimated 3 years)</time_frame>
      <description>Measured from PK blood samples</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Measurement of volume of distribution at steady state (Vss) of ADRX-0706</measure>
      <time_frame>Until study completion (estimated 3 years)</time_frame>
      <description>Measured from PK blood samples</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of anti-drug antibodies (ADA)</measure>
      <time_frame>Until study completion (estimated 3 years)</time_frame>
      <description>Measured from ADA blood samples</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Measurement of objective response rate (ORR) per RECIST 1.1</measure>
      <time_frame>Until study completion (estimated 3 years)</time_frame>
      <description>Percentage of subjects achieving complete response (CR) or partial response (PR)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Measurement of duration of response (DOR)</measure>
      <time_frame>Until study completion (estimated 3 years)</time_frame>
      <description>Time from first response until first evidence of disease progression (PD) or death from any cause</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Measurement of disease control rate (DCR)</measure>
      <time_frame>Until study completion (estimated 3 years)</time_frame>
      <description>Percentage of subjects achieving CR, PR or stable disease (SD)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Measurement of progression free survival (PFS)</measure>
      <time_frame>Until study completion (estimated 3 years)</time_frame>
      <description>Time from the start of study drug until first evidence of PD or death from any cause</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Measurement of overall survival (OS)</measure>
      <time_frame>Until study completion (estimated 3 years)</time_frame>
      <description>Time from the start of study drug until death from any cause</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">114</enrollment>
    <condition>Solid Tumors</condition>
    <arm_group>
      <arm_group_label>Phase 1a Dose Escalation</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Increasing doses of ADRX-0706 will be administered to identify the maximum tolerated dose (MTD) and the recommended dose to be used in the Phase 1b part.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Phase 1b Dose Expansion</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>ADRX-0706 will be initially administered at the dose recommended from the Phase 1a part in 3 disease-specific cohorts.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>ADRX-0706</intervention_name>
      <description>Antibody drug conjugate targeting Nectin-4</description>
      <arm_group_label>Phase 1a Dose Escalation</arm_group_label>
      <arm_group_label>Phase 1b Dose Expansion</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Phase 1a Dose Escalation: Subjects with histologically confirmed select advanced solid&#xD;
               tumors, including urothelial carcinoma (UC), head and neck squamous cell carcinoma&#xD;
               (HNSCC), breast cancer, cervical cancer, ovarian cancer, non-small cell lung cancer&#xD;
               (NSCLC), and pancreatic cancer. Subjects must have received at least one prior&#xD;
               systemic regimen and have no other therapy available known to provide meaningful&#xD;
               clinical benefit in the opinion of the investigator.&#xD;
  &#xD;
            -  Measurable disease according to RECIST version 1.1&#xD;
  &#xD;
            -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1&#xD;
  &#xD;
            -  Adequate hematologic, liver, and renal function&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Active and uncontrolled central nervous system metastases&#xD;
  &#xD;
            -  Significant cardiovascular disease&#xD;
  &#xD;
            -  History of another malignancy other than the one for which the subject is being&#xD;
               treated on this study within 3 years&#xD;
  &#xD;
            -  Receipt of any anticancer or investigational therapy within 5 elimination half-lives&#xD;
               or 14 days (whichever is less)&#xD;
  &#xD;
            -  Any P-gp inducers/inhibitors or strong CYP3A inhibitors received within 14 days prior&#xD;
               to the first dose of study drug&#xD;
  &#xD;
            -  Receiving systemic antimicrobial treatment for active infection; routine antimicrobial&#xD;
               prophylaxis is permitted&#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_contact>
      <last_name>Adcentrx Therapeutics</last_name>
      <phone>858-428-9502</phone>
      <email>clinicaltrials@adcentrx.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>USC Norris Comprehensive Cancer Center</name>
        <address>
          <city>Los Angeles</city>
          <state>California</state>
          <zip>90033</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>START Midwest</name>
        <address>
          <city>Grand Rapids</city>
          <state>Michigan</state>
          <zip>49546</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>START San Antonio</name>
        <address>
          <city>San Antonio</city>
          <state>Texas</state>
          <zip>78229</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>START Mountain Region</name>
        <address>
          <city>West Valley City</city>
          <state>Utah</state>
          <zip>84119</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 6, 2023</study_first_submitted>
    <study_first_submitted_qc>September 12, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 12, 2023</last_update_submitted>
    <last_update_submitted_qc>September 12, 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>
    <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/NCT06036121
  org study id: ADRX-0706-001
  nct id: NCT06036121
  lead sponsor: 
  is fda regulated drug: Yes
  is fda regulated device: No
  The primary purpose of this study is to assess the safety, tolerability, and
        pharmacokinetics, and to identify the optimal dose of ADRX-0706 in patients with select
        advanced solid tumors.
  This is a 2 part study. The Phase 1a will consist of a dose escalation of ADRX-0706 to
        evaluate initial safety and tolerability in patients with select advanced solid tumors, and
        to identify the recommended dose to be used in the Phase 1b. The Phase 1b will further
        evaluate the safety and tolerability, as well as preliminary efficacy, and identify the
        optimal dose of ADRX-0706 in 3 disease-specific expansion cohorts.
  allocation: Non-Randomized
  intervention model: Sequential Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Incidence of adverse events
  time frame: Until study completion (estimated 3 years)
  measure: Measurement of maximum plasma concentration (Cmax) of ADRX-0706
  time frame: Until study completion (estimated 3 years)
  description: Measured from pharmacokinetic (PK) blood samples
  measure: Measurement of trough concentration (Ctrough) of ADRX-0706
  time frame: Until study completion (estimated 3 years)
  description: Measured from PK blood samples
  measure: Measurement of area under the serum concentration-time curve (AUC) of ADRX-0706
  time frame: Until study completion (estimated 3 years)
  description: Measured from PK blood samples
  measure: Measurement of terminal half-life (t1/2) of ADRX-0706
  time frame: Until study completion (estimated 3 years)
  description: Measured from PK blood samples
  measure: Measurement of systemic clearance (CL) of ADRX-0706
  time frame: Until study completion (estimated 3 years)
  description: Measured from PK blood samples
  measure: Measurement of volume of distribution at steady state (Vss) of ADRX-0706
  time frame: Until study completion (estimated 3 years)
  description: Measured from PK blood samples
  measure: Incidence of anti-drug antibodies (ADA)
  time frame: Until study completion (estimated 3 years)
  description: Measured from ADA blood samples
  measure: Measurement of objective response rate (ORR) per RECIST 1.1
  time frame: Until study completion (estimated 3 years)
  description: Percentage of subjects achieving complete response (CR) or partial response (PR)
  measure: Measurement of duration of response (DOR)
  time frame: Until study completion (estimated 3 years)
  description: Time from first response until first evidence of disease progression (PD) or death from any cause
  measure: Measurement of disease control rate (DCR)
  time frame: Until study completion (estimated 3 years)
  description: Percentage of subjects achieving CR, PR or stable disease (SD)
  measure: Measurement of progression free survival (PFS)
  time frame: Until study completion (estimated 3 years)
  description: Time from the start of study drug until first evidence of PD or death from any cause
  measure: Measurement of overall survival (OS)
  time frame: Until study completion (estimated 3 years)
  description: Time from the start of study drug until death from any cause
  arm group label: Phase 1a Dose Escalation
  arm group type: Experimental
  description: Increasing doses of ADRX-0706 will be administered to identify the maximum tolerated dose (MTD) and the recommended dose to be used in the Phase 1b part.
  arm group label: Phase 1b Dose Expansion
  arm group type: Experimental
  description: ADRX-0706 will be initially administered at the dose recommended from the Phase 1a part in 3 disease-specific cohorts.
  intervention type: Drug
  intervention name: ADRX-0706
  description: Antibody drug conjugate targeting Nectin-4
  arm group label: Phase 1a Dose Escalation
  arm group label: Phase 1b Dose Expansion
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Adcentrx Therapeutics
  phone: 858-428-9502
  email: clinicaltrials@adcentrx.com
  facility: 
  status: Not yet recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  country: United States
  responsible party type: Sponsor
  mesh term: Neoplasms
  sharing ipd: No