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/NCT05979155</url>
    </required_header>
    <id_info>
      <org_study_id>NWY001-101</org_study_id>
      <nct_id>NCT05979155</nct_id>
    </id_info>
    <brief_title>A Study of NWY001 in Subjects With Advanced Solid Tumors</brief_title>
    <official_title>A Multicenter, Non-randomized, Open-label, Multiple-Dose Phase I Study of NWY001, in Subjects With Advanced Solid Tumors</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Chipscreen Biosciences, Ltd.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Chipscreen Biosciences, Ltd.</source>
    <oversight_info>
      <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 Phase 1, single-arm, open-label, dose-escalation study in patients with advanced&#xD;
        solid tumors including 2 parts:&#xD;
  &#xD;
        Part 1: Dose-Escalation Part Part 2: Dose-Expansion Part&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Part 1: Patients with advanced solid tumors that has relapsed from or is refractory to&#xD;
        standard therapy or for which no standard therapy exists will be enrolled in different&#xD;
        cohorts.&#xD;
  &#xD;
        Part 2: Recommended Phase 2 dose (RP2D) of NWY001 will be given to all patients enrolled in&#xD;
        this part.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2023</start_date>
    <completion_date type="Anticipated">May 2028</completion_date>
    <primary_completion_date type="Anticipated">January 2026</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>Dose-limiting toxicity (DLT)</measure>
      <time_frame>Up to 21 days</time_frame>
      <description>Number of patients experienced any dose limited toxicity</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Incidence of adverse events (AEs)</measure>
      <time_frame>Until 30 days after the last dose of the study drug</time_frame>
      <description>Number of patients experienced AEs</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Objective response rate (ORR)</measure>
      <time_frame>Until 30 days after the last dose of the study drug</time_frame>
      <description>The proportion of patients who have a complete response (CR) or partial response (PR), as determined by the Investigator at local site per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Disease control rate (DCR)</measure>
      <time_frame>Until 30 days after the last dose of the study drug</time_frame>
      <description>The proportion of patients who have a CR or PR or stable disease (SD), as determined by the Investigator at local site per RECIST 1.1</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Progression free survival (PFS)</measure>
      <time_frame>Until 30 days after the last dose of the study drug</time_frame>
      <description>Time to progression as assessed by the Investigator at local site per RECIST 1.1, or death due to any cause</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Maximum plasma concentration (Cmax)</measure>
      <time_frame>From pre-dose to 30 days after the last dose of the study drug</time_frame>
      <description>Pharmacokinetic profile of NWY001</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to Cmax (Tmax)</measure>
      <time_frame>From pre-dose to 30 days after the last dose of the study drug</time_frame>
      <description>Pharmacokinetic profile of NWY001</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Area under the plasma concentration-time curve from 0 to infinity (AUC 0-inf)</measure>
      <time_frame>From pre-dose to 30 days after the last dose of the study drug</time_frame>
      <description>Pharmacokinetic profile of NWY001</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Tumor necrosis factor-α (TNF-α)</measure>
      <time_frame>From pre-dose to 30 days after the last dose of the study drug</time_frame>
      <description>Pharmacodynamic profile of NWY001</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Interleukin-6 (IL-6)</measure>
      <time_frame>From pre-dose to 30 days after the last dose of the study drug</time_frame>
      <description>Pharmacodynamic profile of NWY001</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of anti-drug antibody (ADA)</measure>
      <time_frame>From pre-dose to 30 days after the last dose of the study drug</time_frame>
      <description>Immunogenicity of NWY001</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of neutralizing antibody (NAb)</measure>
      <time_frame>From pre-dose to 30 days after the last dose of the study drug</time_frame>
      <description>Immunogenicity of NWY001</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">196</enrollment>
    <condition>Advanced Solid Tumor</condition>
    <arm_group>
      <arm_group_label>Study arm (multiple doses of NWY001)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Part 1: dose-escalation of monotherapy NWY001</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Study arm (RP2D of NWY001)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Part 2: dose-expansion of monotherapy NWY001</description>
    </arm_group>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>NWY001</intervention_name>
      <description>Part 1: Participants will be given a single-dose of NWY001 intravenously once every 3 weeks until a discontinuation criteria was met during treatment period.</description>
      <arm_group_label>Study arm (multiple doses of NWY001)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>NWY001</intervention_name>
      <description>Part 2: Participants will be given RP2D of NWY001 intravenously once every 3 weeks until a discontinuation criteria was met during treatment period.</description>
      <arm_group_label>Study arm (RP2D of NWY001)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Willingness to sign a written informed consent document&#xD;
  &#xD;
            2. Participant with advanced solid malignant tumor that has relapsed from or is&#xD;
               refractory to standard therapy or for which no standard therapy exists&#xD;
  &#xD;
            3. 18~75 years of age at the time of screening&#xD;
  &#xD;
            4. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1&#xD;
  &#xD;
            5. Life expectancy ≥3 months&#xD;
  &#xD;
            6. Laboratory tests meet the following criteria (no corrective treatment, such as G-CSF,&#xD;
               erythropoietin, and blood transfusion, within 14 days before first dose):&#xD;
  &#xD;
          1) absolute neutrophil count (ANC) ≥1.5×109/L 2) platelet ≥100×109/L 3) hemoglobin ≥90 g/L&#xD;
          4) creatinine clearance &gt;50 mL/min (according to Cockcroft-Gault equation) 5) both alanine&#xD;
          aminotransferase (ALT) and aspartate aminotransferase (AST) ≤1.5×upper limit of normal&#xD;
          (ULN) (≤5×ULN for patients with hepatic metastasis) 6) total bilirubin ≤1.5×ULN (≤3×ULN for&#xD;
          patients with gilbert syndrome) 7) international normalized ratio (INR) &lt;2.0, activated&#xD;
          partial thromboplastin time (aPTT) ≤1.5×ULN&#xD;
  &#xD;
          7. Prior anti-cancer therapy meets the following criteria:&#xD;
  &#xD;
            1. major surgery ≥4 weeks&#xD;
  &#xD;
            2. radiotherapy ≥4 weeks&#xD;
  &#xD;
            3. endocrine therapy ≥2 weeks&#xD;
  &#xD;
            4. chemotherapy (including antibody) ≥3 weeks&#xD;
  &#xD;
            5. immunotherapy ≥4 weeks&#xD;
  &#xD;
          8. At least one measurable target lesion as defined by RECIST1.1&#xD;
  &#xD;
          9. For part 2a: Participant has a diagnosis of histologically confirmed advanced&#xD;
          (unresectable) or metastatic gastric or gastroesophageal junction adenocarcinoma&#xD;
  &#xD;
            1. participant with HER2 overexpression (IHC 3+ or IHC 2+/ISH+) is refractory or&#xD;
               intolerant to standard therapy or for which no standard therapy exists. Prior&#xD;
               treatment with trastuzumab or HER2-targeted drugs&#xD;
  &#xD;
            2. participant with no HER2 expression is refractory or intolerant to standard therapy or&#xD;
               for which no standard therapy exists&#xD;
  &#xD;
          10. For part 2b: Participant has a diagnosis of histologically confirmed advanced&#xD;
          esophageal squamous carcinoma&#xD;
  &#xD;
          11. For part 2c: Participant has a diagnosis of histologically confirmed advanced&#xD;
          pancreatic ductal adenocarcinoma&#xD;
  &#xD;
          12. For part 2d: Participant has a diagnosis of histologically confirmed advanced&#xD;
          hepatocellular carcinoma&#xD;
  &#xD;
          13. For part 2e: Participant has a diagnosis of histologically confirmed advanced&#xD;
          intrahepatic cholangiocarcinoma&#xD;
  &#xD;
          14. For part 2f: Participant has a diagnosis of histologically confirmed advanced&#xD;
          MSI-H/dMMR colorectal cancer&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          1. Current or previous history of other active aggressive malignancies in the last 5 years,&#xD;
          except :&#xD;
  &#xD;
            1. previous history of non-aggressive malignancies, such as cervical carcinoma in situ,&#xD;
               melanoma in situ, or ductal carcinoma in situ of the breast that remains in complete&#xD;
               remission for years after curative treatment&#xD;
  &#xD;
            2. malignancies with negligible risk of metastasis or death (such as adequately treated&#xD;
               basal or squamous cell skin cancer and focal prostate cancer)&#xD;
  &#xD;
          2. Current or previous history of hematological malignancies&#xD;
  &#xD;
          3. Primary central nervous system (CNS) malignancies or CNS metastases&#xD;
  &#xD;
          4. History of allergy or hypersensitivity to monoclonal antibodies or excipients, or a&#xD;
          known history of allergy to antibodies produced by Chinese hamster ovary cell&#xD;
  &#xD;
          5. Uncontrolled infection that requires intravenous antibiotics, antivirals, or antifungal&#xD;
          medications&#xD;
  &#xD;
          6. History of clinically significant lung diseases (such as interstitial pneumonia,&#xD;
          pneumonia, pulmonary fibrosis, and severe radiation pneumonia), or patients suspected of&#xD;
          having these diseases on radiographic examination during the screening period&#xD;
  &#xD;
          7. Uncontrolled complications, including, but not limited to, persistent active infections,&#xD;
          active coagulopathy, uncontrolled cardiovascular disease, uncontrolled immune disease,&#xD;
          uncontrolled diabetes, uncontrolled chest and abdominal fluid accumulation, psychiatric&#xD;
          disorders that do not meet study requirements, and other serious conditions requiring&#xD;
          systemic treatment&#xD;
  &#xD;
          8. Known history of HIV, active infections of hepatitis B or hepatitis C&#xD;
  &#xD;
          9. Active pulmonary tuberculosis. Participants vaccinated with BCG vaccine may be false&#xD;
          positive for PPD, and they could be enrolled if negative for IGRA&#xD;
  &#xD;
          10. Women who are pregnant or breastfeeding or intended to become pregnant during the study&#xD;
          period&#xD;
  &#xD;
          11. Participants of childbearing potential who refuse to take highly effective&#xD;
          contraceptive measures during the entire study treatment period and for 120 days after the&#xD;
          last dose of study drug&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Ruihua Xu, Ph.D.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Sun Yat-sen University Cancer Cancer</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Xinhao Wang</last_name>
      <phone>+86 0755-36993550</phone>
      <email>xinhwang@chipscreen.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Sun Yat-sen University Cancer Cancer</name>
        <address>
          <city>Guangzhou</city>
          <state>Guangdong</state>
          <zip>510060</zip>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Ruihua Xu, Ph.D.</last_name>
        <phone>+86 020-87343795</phone>
        <email>xurh@sysucc.org.cn</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 20, 2023</study_first_submitted>
    <study_first_submitted_qc>August 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>August 6, 2023</last_update_submitted>
    <last_update_submitted_qc>August 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 9, 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/NCT05979155
  org study id: NWY001-101
  nct id: NCT05979155
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This is a Phase 1, single-arm, open-label, dose-escalation study in patients with advanced
        solid tumors including 2 parts:
  
        Part 1: Dose-Escalation Part Part 2: Dose-Expansion Part
  Part 1: Patients with advanced solid tumors that has relapsed from or is refractory to
        standard therapy or for which no standard therapy exists will be enrolled in different
        cohorts.
  
        Part 2: Recommended Phase 2 dose (RP2D) of NWY001 will be given to all patients enrolled in
        this part.
  allocation: Non-Randomized
  intervention model: Sequential Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Dose-limiting toxicity (DLT)
  time frame: Up to 21 days
  description: Number of patients experienced any dose limited toxicity
  measure: Incidence of adverse events (AEs)
  time frame: Until 30 days after the last dose of the study drug
  description: Number of patients experienced AEs
  measure: Objective response rate (ORR)
  time frame: Until 30 days after the last dose of the study drug
  description: The proportion of patients who have a complete response (CR) or partial response (PR), as determined by the Investigator at local site per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1
  measure: Disease control rate (DCR)
  time frame: Until 30 days after the last dose of the study drug
  description: The proportion of patients who have a CR or PR or stable disease (SD), as determined by the Investigator at local site per RECIST 1.1
  measure: Progression free survival (PFS)
  time frame: Until 30 days after the last dose of the study drug
  description: Time to progression as assessed by the Investigator at local site per RECIST 1.1, or death due to any cause
  measure: Maximum plasma concentration (Cmax)
  time frame: From pre-dose to 30 days after the last dose of the study drug
  description: Pharmacokinetic profile of NWY001
  measure: Time to Cmax (Tmax)
  time frame: From pre-dose to 30 days after the last dose of the study drug
  description: Pharmacokinetic profile of NWY001
  measure: Area under the plasma concentration-time curve from 0 to infinity (AUC 0-inf)
  time frame: From pre-dose to 30 days after the last dose of the study drug
  description: Pharmacokinetic profile of NWY001
  measure: Tumor necrosis factor-α (TNF-α)
  time frame: From pre-dose to 30 days after the last dose of the study drug
  description: Pharmacodynamic profile of NWY001
  measure: Interleukin-6 (IL-6)
  time frame: From pre-dose to 30 days after the last dose of the study drug
  description: Pharmacodynamic profile of NWY001
  measure: Incidence of anti-drug antibody (ADA)
  time frame: From pre-dose to 30 days after the last dose of the study drug
  description: Immunogenicity of NWY001
  measure: Incidence of neutralizing antibody (NAb)
  time frame: From pre-dose to 30 days after the last dose of the study drug
  description: Immunogenicity of NWY001
  arm group label: Study arm (multiple doses of NWY001)
  arm group type: Experimental
  description: Part 1: dose-escalation of monotherapy NWY001
  arm group label: Study arm (RP2D of NWY001)
  arm group type: Experimental
  description: Part 2: dose-expansion of monotherapy NWY001
  intervention type: Biological
  intervention name: NWY001
  description: Part 1: Participants will be given a single-dose of NWY001 intravenously once every 3 weeks until a discontinuation criteria was met during treatment period.
  arm group label: Study arm (multiple doses of NWY001)
  intervention type: Biological
  intervention name: NWY001
  description: Part 2: Participants will be given RP2D of NWY001 intravenously once every 3 weeks until a discontinuation criteria was met during treatment period.
  arm group label: Study arm (RP2D of NWY001)
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Ruihua Xu, Ph.D.
  role: Principal Investigator
  affiliation: Sun Yat-sen University Cancer Cancer
  last name: Xinhao Wang
  phone: +86 0755-36993550
  email: xinhwang@chipscreen.com
  facility: 
  contact: 
  country: China
  responsible party type: Sponsor
  mesh term: Neoplasms
  sharing ipd: No