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/NCT06009835</url>
    </required_header>
    <id_info>
      <org_study_id>DOTr/DOTa for Solid Tumor</org_study_id>
      <nct_id>NCT06009835</nct_id>
    </id_info>
    <brief_title>DOTr/DOTa Algorithm Guidance for Refractory Solid Tumors</brief_title>
    <official_title>An Open, Single Center Clinical Study Based on DarwinOncoTreatTM (DOTr) and DarwinOncoTargetTM (DOTa) Algorithm Guidance for Treating Solid Tumor Patients Who Are Exhausted or Unable to Tolerate Standard Treatment Regimens</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Tianjin Medical University Second Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Tianjin Medical University Second Hospital</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
    </oversight_info>
    <brief_summary>
      <textblock>
        This study is an open, single center clinical study targeting solid tumor patients who have&#xD;
        exhausted or cannot tolerate standard treatment regimens. The main purpose of this study is&#xD;
        to investigate the feasibility, efficacy, and safety of selecting treatment regimens based on&#xD;
        DOTr/DOTa results for solid tumor patients who have exhausted or cannot tolerate standard&#xD;
        treatment regimens.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Both OncoTarget(DarwinOncoTargetTM (DOTa)), which identifies high-affinity inhibitors of&#xD;
        individual master regulator (MR) proteins, and OncoTreat(DarwinOncoTreatTM (DOTr)), which&#xD;
        identifies drugs that invert the transcriptional activity of hyperconnected MR modules,&#xD;
        produced highly significant 30-day disease control rates (68% and 91%, respectively).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 7, 2022</start_date>
    <completion_date type="Anticipated">September 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">August 7, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Only</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Feasibility of selecting treatment plans based on DOTr/DOTA result</measure>
      <time_frame>Through study completion, an expected average of 2year</time_frame>
      <description>The proportion of patients who successfully develop treatment plans based on DOTr and DOTa test</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>ORR</measure>
      <time_frame>Through study completion, an expected average of 1 year</time_frame>
      <description>Objective response rate (ORR) based on RECIST 1.1 criteria for patients receiving recommended treatment regimens</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>PFS2/PFS1</measure>
      <time_frame>Through study completion, an expected average of 1 year</time_frame>
      <description>he progression free survival (PFS1) after the most recent treatment before enrollment is defined as the progression of the disease from the most recent treatment before enrollment;&#xD;
  The progression free survival period (PFS2) after enrollment is defined as the time from matched targeted therapy or unmatched therapy to disease progression or death</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>AEs</measure>
      <time_frame>Through study completion, an expected average of 1 year</time_frame>
      <description>Number of participants with adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 5.0</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">15</enrollment>
    <condition>Solid Tumor</condition>
    <condition>Individuation</condition>
    <arm_group>
      <arm_group_label>Treatment group based on DOTr/DOTA detection result</arm_group_label>
      <description>Develop a final treatment plan based on DOTr/DOTA test results, MTB consultation expert opinions, and drug accessibility</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Recommended treatment plan</intervention_name>
      <description>Develop a final treatment plan based on DOTr/DOTA test results, MTB consultation expert opinions, and drug accessibility</description>
      <arm_group_label>Treatment group based on DOTr/DOTA detection result</arm_group_label>
    </intervention>
    <biospec_retention>Samples With DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        Tumor tissue&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          Solid tumor patients who are exhausted or unable to tolerate standard treatment regimens&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. The subjects must be able to understand the procedures and methods of this study, be&#xD;
               willing to strictly follow the clinical trial protocol to complete this trial, and&#xD;
               voluntarily sign a written informed consent form;&#xD;
  &#xD;
            2. Patients aged ≥ 18 years old;&#xD;
  &#xD;
            3. Solid tumor patients who are depleted of standard treatment or unable to tolerate&#xD;
               standard treatment regimens;&#xD;
  &#xD;
            4. According to the RECIST solid tumor efficacy evaluation criteria, there should be at&#xD;
               least one measurable lesion;&#xD;
  &#xD;
            5. ECOG PS score 0-4 (3-4 score only for patients caused by tumor);&#xD;
  &#xD;
            6. The expected survival period is not less than 12 weeks;&#xD;
  &#xD;
            7. Women of childbearing age must have a Pregnancy test (serum) within 7 days before&#xD;
               enrollment, and the result is negative, and are willing to use appropriate methods of&#xD;
               contraception during the test period and within 8 weeks after the last administration&#xD;
               of the test drug;&#xD;
  &#xD;
            8. The subjects voluntarily joined this study, signed an informed consent form, had good&#xD;
               compliance, and cooperated with follow-up;&#xD;
  &#xD;
            9. If the main organs function normally, they meet the following standards:&#xD;
  &#xD;
          The blood routine examination standard must comply with (no blood transfusion or blood&#xD;
          products within 14 days, no correction using G-CSF or other hematopoietic stimulating&#xD;
          factors): Hb ≥ 90g/L; ANC ≥ 1.5 × 109/L; PLT ≥ 90 × 109/L;Biochemical examination must meet&#xD;
          the following standards: TBIL ≤ 1 × ULN; ALT, AST ≤ 1.5 × ULN; ALP ≤ 2.5 × ULN; BUN and Cr&#xD;
          ≤ 1.5 × ULN; Color Doppler echocardiography: left ventricular Ejection fraction (LVEF) ≥&#xD;
          50%.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Severe heart disease or discomfort that cannot be treated;&#xD;
  &#xD;
            2. Those who suffer from mental illness or abuse of psychotropic substances and are&#xD;
               unable to cooperate;&#xD;
  &#xD;
            3. Pregnant or lactating female patients;&#xD;
  &#xD;
            4. Participating in other clinical trials at the same time;&#xD;
  &#xD;
            5. Researchers believe that individuals are not suitable for enrollment.&#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>HaiTao Wang, Ph.D</last_name>
      <role>Principal Investigator</role>
      <affiliation>Tianjin Medical University Second Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>HaiTao Wang, Ph.D</last_name>
      <phone>+86-022-88326385</phone>
      <email>peterrock2000@126.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Lili Wang, Ph.D</last_name>
      <phone>+86-022-88326610</phone>
      <email>wangliliaigang@163.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Tianjin Medical Unversity Second Hospital</name>
        <address>
          <city>Tianjin</city>
          <state>Tianjin</state>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Haitao Wang, Ph.D</last_name>
        <phone>+86-022-88326385</phone>
        <email>peterrock2000@126.com</email>
      </contact>
      <contact_backup>
        <last_name>Lili Wang, MM</last_name>
        <phone>+86-022-88326610</phone>
        <email>wangliliaigang@163.com</email>
      </contact_backup>
      <investigator>
        <last_name>Haitao Wang</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Lili Wang</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Jinhuan Wang</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Dingkun Hou</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <reference>
      <citation>Mundi PS, Dela Cruz FS, Grunn A, Diolaiti D, Mauguen A, Rainey AR, Guillan K, Siddiquee A, You D, Realubit R, Karan C, Ortiz MV, Douglass EF, Accordino M, Mistretta S, Brogan F, Bruce JN, Caescu CI, Carvajal RD, Crew KD, Decastro G, Heaney M, Henick BS, Hershman DL, Hou JY, Iwamoto FM, Jurcic JG, Kiran RP, Kluger MD, Kreisl T, Lamanna N, Lassman AB, Lim EA, Manji GA, McKhann GM, McKiernan JM, Neugut AI, Olive KP, Rosenblat T, Schwartz GK, Shu CA, Sisti MB, Tergas A, Vattakalam RM, Welch M, Wenske S, Wright JD, Canoll P, Hibshoosh H, Kalinsky K, Aburi M, Sims PA, Alvarez MJ, Kung AL, Califano A. A Transcriptome-Based Precision Oncology Platform for Patient-Therapy Alignment in a Diverse Set of Treatment-Resistant Malignancies. Cancer Discov. 2023 Jun 2;13(6):1386-1407. doi: 10.1158/2159-8290.CD-22-1020.</citation>
      <PMID>37061969</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 19, 2023</study_first_submitted>
    <study_first_submitted_qc>August 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 24, 2023</study_first_posted>
    <last_update_submitted>August 23, 2023</last_update_submitted>
    <last_update_submitted_qc>August 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 24, 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>
    <!-- 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/NCT06009835
  org study id: DOTr/DOTa for Solid Tumor
  nct id: NCT06009835
  lead sponsor: 
  is fda regulated drug: No
  This study is an open, single center clinical study targeting solid tumor patients who have
        exhausted or cannot tolerate standard treatment regimens. The main purpose of this study is
        to investigate the feasibility, efficacy, and safety of selecting treatment regimens based on
        DOTr/DOTa results for solid tumor patients who have exhausted or cannot tolerate standard
        treatment regimens.
  Both OncoTarget(DarwinOncoTargetTM (DOTa)), which identifies high-affinity inhibitors of
        individual master regulator (MR) proteins, and OncoTreat(DarwinOncoTreatTM (DOTr)), which
        identifies drugs that invert the transcriptional activity of hyperconnected MR modules,
        produced highly significant 30-day disease control rates (68% and 91%, respectively).
  observational model: Case-Only
  time perspective: Prospective
  measure: Feasibility of selecting treatment plans based on DOTr/DOTA result
  time frame: Through study completion, an expected average of 2year
  description: The proportion of patients who successfully develop treatment plans based on DOTr and DOTa test
  measure: ORR
  time frame: Through study completion, an expected average of 1 year
  description: Objective response rate (ORR) based on RECIST 1.1 criteria for patients receiving recommended treatment regimens
  measure: PFS2/PFS1
  time frame: Through study completion, an expected average of 1 year
  description: he progression free survival (PFS1) after the most recent treatment before enrollment is defined as the progression of the disease from the most recent treatment before enrollment;
  The progression free survival period (PFS2) after enrollment is defined as the time from matched targeted therapy or unmatched therapy to disease progression or death
  measure: AEs
  time frame: Through study completion, an expected average of 1 year
  description: Number of participants with adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 5.0
  arm group label: Treatment group based on DOTr/DOTA detection result
  description: Develop a final treatment plan based on DOTr/DOTA test results, MTB consultation expert opinions, and drug accessibility
  intervention type: Other
  intervention name: Recommended treatment plan
  description: Develop a final treatment plan based on DOTr/DOTA test results, MTB consultation expert opinions, and drug accessibility
  arm group label: Treatment group based on DOTr/DOTA detection result
  Tumor tissue
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: HaiTao Wang, Ph.D
  role: Principal Investigator
  affiliation: Tianjin Medical University Second Hospital
  last name: HaiTao Wang, Ph.D
  phone: +86-022-88326385
  email: peterrock2000@126.com
  last name: Lili Wang, Ph.D
  phone: +86-022-88326610
  email: wangliliaigang@163.com
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  country: China
  citation: Mundi PS, Dela Cruz FS, Grunn A, Diolaiti D, Mauguen A, Rainey AR, Guillan K, Siddiquee A, You D, Realubit R, Karan C, Ortiz MV, Douglass EF, Accordino M, Mistretta S, Brogan F, Bruce JN, Caescu CI, Carvajal RD, Crew KD, Decastro G, Heaney M, Henick BS, Hershman DL, Hou JY, Iwamoto FM, Jurcic JG, Kiran RP, Kluger MD, Kreisl T, Lamanna N, Lassman AB, Lim EA, Manji GA, McKhann GM, McKiernan JM, Neugut AI, Olive KP, Rosenblat T, Schwartz GK, Shu CA, Sisti MB, Tergas A, Vattakalam RM, Welch M, Wenske S, Wright JD, Canoll P, Hibshoosh H, Kalinsky K, Aburi M, Sims PA, Alvarez MJ, Kung AL, Califano A. A Transcriptome-Based Precision Oncology Platform for Patient-Therapy Alignment in a Diverse Set of Treatment-Resistant Malignancies. Cancer Discov. 2023 Jun 2;13(6):1386-1407. doi: 10.1158/2159-8290.CD-22-1020.
  PMID: 37061969
  responsible party type: Sponsor
  mesh term: Neoplasms