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/NCT06028373</url>
    </required_header>
    <id_info>
      <org_study_id>ATG-031-001</org_study_id>
      <nct_id>NCT06028373</nct_id>
    </id_info>
    <brief_title>A Study of ATG-031 in Advanced Solid Tumors or B-cell Non-Hodgkin Lymphomas</brief_title>
    <official_title>A First-in-Human Phase I Study of ATG-031 in Patients With Advanced Solid Tumors or B-cell Non-Hodgkin Lymphomas</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Antengene Biologics Limited</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Antengene Corporation</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>
        ATG-031 study (alias: PERFORM) is a multicenter, open-label, Phase 1 study of ATG-031 in&#xD;
        patients with advanced solid tumors or B-NHL. The study design includes a Dose Escalation&#xD;
        Phase and a Dose Expansion Phase, and will enroll patients with advanced solid tumors (i.e.,&#xD;
        preferred tumor types) or relapsed/refractory (R/R) B-NHLs. The study's primary objective is&#xD;
        to evaluate the safety and tolerability of ATG-031 and determine the RP2D of ATG-031.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a multicenter, open-label, Phase 1 study of ATG-031 in patients with advanced solid&#xD;
        tumors or B-NHL. The study design includes a Dose Escalation Phase and a Dose Expansion&#xD;
        Phase. Dose Escalation Phase: approximately 30-48 patients . Dose Expansion Phase: the number&#xD;
        of patients enrolled will depend on the number of disease cohorts to be expanded and data&#xD;
        observed in the Dose Escalation Phase.The Dose Escalation Phase will enroll patients with&#xD;
        advanced solid tumors. Based on data from dose escalation (e.g., adverse events [AEs],&#xD;
        dose-limiting toxicity [DLT], efficacy data, pharmacodynamic [PDx] data, or pharmacokinetic&#xD;
        [PK] data), the Dose Expansion Phase will enroll patients with selected advanced solid tumors&#xD;
        or B-NHL.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 13, 2023</start_date>
    <completion_date type="Anticipated">June 30, 2026</completion_date>
    <primary_completion_date type="Anticipated">December 31, 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>Sequential Assignment</intervention_model>
      <intervention_model_description>Dose levels are 0.03 mg/kg、 0.1 mg/kg、0.3 mg/kg 、1.0 mg/kg 、2.0 mg/kg、4.0 mg/kg 、6.0 mg/kg 、9.0 mg/kg</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>AE</measure>
      <time_frame>90 days after last dose of treatment</time_frame>
      <description>Evaluate the safety and tolerability of ATG-031</description>
    </primary_outcome>
    <primary_outcome>
      <measure>DLT</measure>
      <time_frame>at the end of cycle 2 ( each cycle is 21 days)</time_frame>
      <description>Evaluate the safety and tolerability of ATG-031</description>
    </primary_outcome>
    <primary_outcome>
      <measure>RP2D</measure>
      <time_frame>at the end of dose escalation, about 1 year</time_frame>
      <description>RP2D will be determined based on safety, tolerability, PK, and preliminary efficacy data</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">48</enrollment>
    <condition>Advanced Solid Tumors</condition>
    <condition>B-cell Non-Hodgkin Lymphomas</condition>
    <arm_group>
      <arm_group_label>ATG-031</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients with advanced solid tumors or B-cell non-Hodgkin lymphomas will be enrolled in the Dose-Escalation Phase.&#xD;
  Dose levels are 0.03 mg/kg、 0.1 mg/kg、0.3 mg/kg 、1.0 mg/kg 、2.0 mg/kg、4.0 mg/kg 、6.0 mg/kg 、9.0 mg/kg.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>ATG-031</intervention_name>
      <description>ATG-031 will be infused Q3W on Day 1 of each cycle, at the starting dose of 0.03 mg/kg and a maximum dose of 9 mg/kg in the Dose Escalation Phase, and the defined MTD if available or OBD in the Dose Expansion Phase. Based on the emerging PK, PDx, safety, and other relevant data, SRC may decide to explore alternative dosing schedules.</description>
      <arm_group_label>ATG-031</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Key Inclusion Criteria:&#xD;
  &#xD;
            1. Histological or cytologically confirmed advanced solid tumor or B-NHL which have&#xD;
               relapsed from or been refractory to all locally available standard therapies.&#xD;
  &#xD;
            2. Adequate hepatic function:&#xD;
  &#xD;
                 1. AST and ALT ≤ 2.5×times ULN (≤ 5 × ULN if liver metastases).&#xD;
  &#xD;
                 2. Total bilirubin ≤ 1.5×ULN (except Gilbert syndrome).&#xD;
  &#xD;
                 3. Lipase and amylase ≤ 2×ULN.&#xD;
  &#xD;
            3. Adequate renal function: calculated creatinine clearance of ≥ 40 mL/min using the&#xD;
               Cockroft- Gault formula.&#xD;
  &#xD;
            4. Adequate bone marrow function without growth factors or blood transfusion within 7&#xD;
               days of the first dose of study treatment.&#xD;
  &#xD;
                 1. Absolute neutrophil count (ANC) ≥ 1.5×109/L.&#xD;
  &#xD;
                 2. Platelet count ≥ 100×109/L.&#xD;
  &#xD;
                 3. Hemoglobin ≥ 90 g/L.&#xD;
  &#xD;
          Key Exclusion Criteria:&#xD;
  &#xD;
            1. Patients with CNS malignancies, except those who are clinically stable for ≥ 4 weeks&#xD;
               and off corticosteroids following prior surgery, whole-brain radiation, or&#xD;
               stereotactic radiosurgery.&#xD;
  &#xD;
            2. Received any other investigational product or prior systemic anticancer therapy&#xD;
               including chemotherapy, immunotherapy, radiotherapy, or other anticancer within 21&#xD;
               days prior to first dose of study&#xD;
  &#xD;
            3. Grade ≥3 irAEs or irAEs that lead to discontinuation of prior immunotherapy.8. Other&#xD;
               primary malignancies developed within 5 years prior to the first dose of the study&#xD;
               treatment&#xD;
  &#xD;
            4. Other primary malignancies developed within 5 years prior to the first dose of the&#xD;
               study treatment&#xD;
  &#xD;
            5. Have active or previous autoimmune diseases that are likely to recur or are at risk of&#xD;
               such diseases judged by the investigator.&#xD;
  &#xD;
            6. Major cardiovascular disease&#xD;
  &#xD;
            7. Active hepatitis B and/or hepatitis C (HBV-DNA or HCV-RNA detectable by local&#xD;
               laboratory, respectively).&#xD;
  &#xD;
            8. Patients with history of human immunodeficiency virus (HIV) infection or acquired&#xD;
               immunodeficiency syndrome (AIDS).&#xD;
  &#xD;
            9. A history of allograft organ transplantation for solid tumor or allogeneic&#xD;
               hematopoietic stem cell transplantation for B-NHL patients).&#xD;
  &#xD;
           10. Patients who are pregnant or lactating.&#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>Ashley Liu</last_name>
      <phone>0431292256</phone>
      <email>ting.liu@antengene.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Ran Wei</last_name>
      <phone>13810001510</phone>
      <email>ran.wei@antengene.com</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 25, 2023</study_first_submitted>
    <study_first_submitted_qc>August 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 8, 2023</study_first_posted>
    <last_update_submitted>August 31, 2023</last_update_submitted>
    <last_update_submitted_qc>August 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>ATG-031</keyword>
    <keyword>solid tumor</keyword>
    <keyword>CD 24</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Lymphoma</mesh_term>
      <mesh_term>Lymphoma, Non-Hodgkin</mesh_term>
      <mesh_term>Lymphoma, B-Cell</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/NCT06028373
  org study id: ATG-031-001
  nct id: NCT06028373
  lead sponsor: 
  is fda regulated drug: Yes
  is fda regulated device: No
  ATG-031 study (alias: PERFORM) is a multicenter, open-label, Phase 1 study of ATG-031 in
        patients with advanced solid tumors or B-NHL. The study design includes a Dose Escalation
        Phase and a Dose Expansion Phase, and will enroll patients with advanced solid tumors (i.e.,
        preferred tumor types) or relapsed/refractory (R/R) B-NHLs. The study's primary objective is
        to evaluate the safety and tolerability of ATG-031 and determine the RP2D of ATG-031.
  This is a multicenter, open-label, Phase 1 study of ATG-031 in patients with advanced solid
        tumors or B-NHL. The study design includes a Dose Escalation Phase and a Dose Expansion
        Phase. Dose Escalation Phase: approximately 30-48 patients . Dose Expansion Phase: the number
        of patients enrolled will depend on the number of disease cohorts to be expanded and data
        observed in the Dose Escalation Phase.The Dose Escalation Phase will enroll patients with
        advanced solid tumors. Based on data from dose escalation (e.g., adverse events [AEs],
        dose-limiting toxicity [DLT], efficacy data, pharmacodynamic [PDx] data, or pharmacokinetic
        [PK] data), the Dose Expansion Phase will enroll patients with selected advanced solid tumors
        or B-NHL.
  allocation: N/A
  intervention model: Sequential Assignment
  intervention model description: Dose levels are 0.03 mg/kg、 0.1 mg/kg、0.3 mg/kg 、1.0 mg/kg 、2.0 mg/kg、4.0 mg/kg 、6.0 mg/kg 、9.0 mg/kg
  primary purpose: Treatment
  masking: None (Open Label)
  measure: AE
  time frame: 90 days after last dose of treatment
  description: Evaluate the safety and tolerability of ATG-031
  measure: DLT
  time frame: at the end of cycle 2 ( each cycle is 21 days)
  description: Evaluate the safety and tolerability of ATG-031
  measure: RP2D
  time frame: at the end of dose escalation, about 1 year
  description: RP2D will be determined based on safety, tolerability, PK, and preliminary efficacy data
  arm group label: ATG-031
  arm group type: Experimental
  description: Patients with advanced solid tumors or B-cell non-Hodgkin lymphomas will be enrolled in the Dose-Escalation Phase.
  Dose levels are 0.03 mg/kg、 0.1 mg/kg、0.3 mg/kg 、1.0 mg/kg 、2.0 mg/kg、4.0 mg/kg 、6.0 mg/kg 、9.0 mg/kg.
  intervention type: Drug
  intervention name: ATG-031
  description: ATG-031 will be infused Q3W on Day 1 of each cycle, at the starting dose of 0.03 mg/kg and a maximum dose of 9 mg/kg in the Dose Escalation Phase, and the defined MTD if available or OBD in the Dose Expansion Phase. Based on the emerging PK, PDx, safety, and other relevant data, SRC may decide to explore alternative dosing schedules.
  arm group label: ATG-031
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Ashley Liu
  phone: 0431292256
  email: ting.liu@antengene.com
  last name: Ran Wei
  phone: 13810001510
  email: ran.wei@antengene.com
  responsible party type: Sponsor
  mesh term: Lymphoma
  mesh term: Lymphoma, Non-Hodgkin
  mesh term: Lymphoma, B-Cell