<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/NCT04400383</url>
  </required_header>
  <id_info>
    <org_study_id>AB011-ST-01</org_study_id>
    <nct_id>NCT04400383</nct_id>
  </id_info>
  <brief_title>Clinical Trial to Evaluate AB011 Injection in Patients With CLDN18.2-positive Advanced Solid Tumors</brief_title>
  <official_title>An Open, Two-stage, Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of AB011 Injection in Patients With CLDN18.2-positive Advanced Solid Tumors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>CARsgen Therapeutics Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Shanghai East Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>CARsgen Therapeutics Co., Ltd.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <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 an open, two-stage, phase I study to evaluate the safety, tolerability,&#xD;
      pharmacokinetics and preliminary efficacy of AB011 injection in patients with&#xD;
      CLDN18.2-positive advanced solid tumors.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is an open, two-stage, phase I study to evaluate the safety, tolerability,&#xD;
      pharmacokinetics and preliminary efficacy of AB011 injection in patients with&#xD;
      CLDN18.2-positive advanced solid tumors. The study is composed of two stages: stage I is&#xD;
      single treatment and stage II is combo treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">June 4, 2020</start_date>
  <completion_date type="Anticipated">June 1, 2024</completion_date>
  <primary_completion_date type="Anticipated">July 27, 2023</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Stage1：Incidence of adverse events AE of single and multiple dose (according to NCI CTCAE 5.0)</measure>
    <time_frame>From First dose to last patient progression or 6 months, whichever came first</time_frame>
    <description>An AE or SAE is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Stage1：Incidence of adverse events SAE of single and multiple dose (according to NCI CTCAE 5.0)</measure>
    <time_frame>From First dose to last patient progression or 6 months, whichever came first</time_frame>
    <description>An AE or SAE is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Stage 1: The incidence and case number of DLT (Dose Limiting Toxicity) during observation period</measure>
    <time_frame>From first dose up to 28 days</time_frame>
    <description>DLT is short for Dose Limiting Toxicity. dose-limiting describes side effects of a drug or other treatment that are serious enough to prevent an increase in dose or level of that treatment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Stage 2：Incidence of adverse events AE of single and multiple dose for AB011 combinate with XELOX or Gem/nab-P (according to NCI CTCAE 5.0)</measure>
    <time_frame>From First dose to last patient progression or 12 months, whichever came first</time_frame>
    <description>An AE or SAE is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Stage 2：Incidence of adverse events SAE of single and multiple dose for AB011 combinate with XELOX or Gem/nab-P (according to NCI CTCAE 5.0)</measure>
    <time_frame>From First dose to last patient progression or 12 months, whichever came first</time_frame>
    <description>An AE or SAE is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Stage 2: The incidence and case number of DLT (Dose Limiting Toxicity) during observation period</measure>
    <time_frame>From first dose up to 21 days</time_frame>
    <description>DLT is short for Dose Limiting Toxicity. dose-limiting describes side effects of a drug or other treatment that are serious enough to prevent an increase in dose or level of that treatment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Stage 1: Pharmacokinetics: Area Under Curve (AUC) with immunoanalytical method</measure>
    <time_frame>Up to progression of disease after injection, or end of 6 cycle( each cycle is 28 days), whichever came first</time_frame>
    <description>AUC will be recorded from the PK serum samples collected.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage 2: Pharmacokinetics: Area Under Curve (AUC) with immunoanalytical method</measure>
    <time_frame>Up to progression of disease after injection, or end of cycle 6 (each cycle is 21 days), whichever came first</time_frame>
    <description>AUC will be recorded from the PK serum samples collected.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage 1: Pharmacokinetics: clearance rate (CL) with immunoanalytical method</measure>
    <time_frame>Up to progression of disease after injection, or 6 cycle( dose increase), 8 cycle (dose extension), whichever came first</time_frame>
    <description>AUC will be recorded from the PK serum samples collected.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage 2: Pharmacokinetics: clearance rate (CL) with immunoanalytical method</measure>
    <time_frame>Up to progression of disease after injection, or end of cycle 6 (each cycle is 21 days), whichever came first</time_frame>
    <description>AUC will be recorded from the PK serum samples collected.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage 1: Pharmacokinetics: minimum concentration (Cmin) with immunoanalytical method</measure>
    <time_frame>Up to progression of disease after injection, or end of cycle 6（dose increase stage), or cycle 8 (dose expansion stage), each cycle is 28 days, whichever came first</time_frame>
    <description>AUC will be recorded from the PK serum samples collected.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage 2: Pharmacokinetics: minimum concentration (Cmin) with immunoanalytical method</measure>
    <time_frame>Up to progression of disease after injection, or end of cycle 6 (each cycle is 21 days), whichever came first</time_frame>
    <description>AUC will be recorded from the PK serum samples collected.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage 1: Pharmacokinetics: maximum concentration (Cmax) with immunoanalytical method</measure>
    <time_frame>Up to progression of disease after injection, or end of cycle 6（dose increase stage), or cycle 8 (dose expansion stage), each cycle is 28 days, whichever came first</time_frame>
    <description>AUC will be recorded from the PK serum samples collected.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage 2: Pharmacokinetics: maximum concentration (Cmax) with immunoanalytical method</measure>
    <time_frame>Up to progression of disease after injection, or end of cycle 6 (each cycle is 21 days), whichever came first</time_frame>
    <description>AUC will be recorded from the PK serum samples collected.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage 1: Pharmacokinetics: half-life (T1/2) with immunoanalytical method</measure>
    <time_frame>Up to progression of disease after injection, or end of cycle 6（dose increase stage), or cycle 8 (dose expansion stage), each cycle is 28 days, whichever came first</time_frame>
    <description>AUC will be recorded from the PK serum samples collected.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage 2: Pharmacokinetics: half-life (T1/2) with immunoanalytical method</measure>
    <time_frame>Up to progression of disease after injection, or end of cycle 6 (each cycle is 21 days), whichever came first</time_frame>
    <description>AUC will be recorded from the PK serum samples collected.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage 1: volume of distribution (Vd) with immunoanalytical method</measure>
    <time_frame>Up to progression of disease after injection, or end of cycle 6（dose increase stage), or cycle 8 (dose expansion stage), each cycle is 28 days, whichever came first</time_frame>
    <description>AUC will be recorded from the PK serum samples collected.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage 2: volume of distribution (Vd) with immunoanalytical method</measure>
    <time_frame>Up to progression of disease after injection, or end of cycle 6 (each cycle is 21 days), whichever came first</time_frame>
    <description>AUC will be recorded from the PK serum samples collected.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Immunogenicity</measure>
    <time_frame>Up to 8 months (end of treatment)</time_frame>
    <description>Incidence of anti-drug antibodies</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficacy: objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1)</measure>
    <time_frame>Up to progression of disease after injection, or 6 months( stage 1), 12 months (stage 2) whichever came first</time_frame>
    <description>These measure are defined as the proportion of subjects with complete or partial objective response based on RECIST V1.1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficacy: disease control rate (DCR) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1)</measure>
    <time_frame>Up to progression of disease after injection, or 6 months( stage 1), 12 months (stage 2) whichever came first</time_frame>
    <description>These measure are defined as the proportion of subjects with complete or partial objective response based on RECIST V1.1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficacy: duration of response (DOR) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1)</measure>
    <time_frame>Up to progression of disease after injection, or 6 months( stage 1), 12 months (stage 2) whichever came first</time_frame>
    <description>These measure are defined as the proportion of subjects with complete or partial objective response based on RECIST V1.1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficacy: progression free survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1)</measure>
    <time_frame>Up to progression of disease after injection, or 6 months( stage 1), 12 months (stage 2) whichever came first</time_frame>
    <description>These measure are defined as the proportion of subjects with complete or partial objective response based on RECIST V1.1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficacy: overall survival (OS) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1)</measure>
    <time_frame>Up to progression of disease after injection, or 6 months( stage 1), 12 months (stage 2) whichever came first</time_frame>
    <description>These measure are defined as the proportion of subjects with complete or partial objective response based on RECIST V1.1.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">62</enrollment>
  <condition>Solid Tumor</condition>
  <condition>Gastric Cancer</condition>
  <condition>Pancreatic Adenocarcinoma</condition>
  <arm_group>
    <arm_group_label>AB011 Injection</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>AB011 Injection treatment. This phase 1 trial will include two stages, a single treatment stage and a Combo treatment stage.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>AB011 Injection</intervention_name>
    <description>Stage 1 Single treatment: AB011 Injection with dose escalation of 1mg/kg up to 40mg/kg, as well as dose expansion with recommended dose level from dose escalation.&#xD;
Stage 2 Combo Treatment: AB011 combine XELOX( GC) or Gem/nab-P (PC) Injection with dose escalation of 10mg/kg up to 30mg/kg, as well as dose expansion with recommended dose level from dose escalation.</description>
    <arm_group_label>AB011 Injection</arm_group_label>
    <other_name>recombinant humanized anti-Claudin 18.2 monoclonal antibody injection</other_name>
    <other_name>recombinant humanized anti-CLDN 18.2 monoclonal antibody injection</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Stage 1:&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  1. Aged 18 to 80 years, either sex;&#xD;
&#xD;
          -  2. Patients with histologically or cytologic confirmed advanced solid tumors should&#xD;
             have failed the standard treatment, or have no standard treatment regimen available,&#xD;
             or have no access to standard treatment;&#xD;
&#xD;
          -  3. Tumor tissue samples is CLDN18.2 positive;&#xD;
&#xD;
          -  4. According to RECIST1.1, there are at least one evaluable tumor lesion during dose&#xD;
             escalation period (stage 1), and at least one measurable tumor lesion during dose&#xD;
             expansion period (stage 2);&#xD;
&#xD;
          -  5. The ECOG score is 0 to 1;&#xD;
&#xD;
          -  6. Expected survival &gt; 3 months;&#xD;
&#xD;
          -  7. Various organs in good condition;&#xD;
&#xD;
          -  8. Fertile eligible patients (male and female) and their partners are willing to use a&#xD;
             reliable method of contraception (hormones, barriers or abstinence) during the study&#xD;
             and within 90 days after the last study treatment; women of childbearing potential&#xD;
             must be tested for serum or urine pregnancy within 7 days before enrollment with&#xD;
             negative results;&#xD;
&#xD;
          -  9. Patients are informed of this study before the trial and sign written informed&#xD;
             consent form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  1. Received anti-tumor therapies within 4 weeks prior to first administration of study&#xD;
             drug, except: within 6 weeks for nitrosoureas or mitomycin C, within 2 weeks or 5&#xD;
             half-life of drugs (whichever longer) for oral fluorouracils and small molecular&#xD;
             targeted drugs, and within 2 weeks for traditional Chinese medicines with indications&#xD;
             of anti-tumor;&#xD;
&#xD;
          -  2. Received other non-marketed clinical trial drugs within 4 weeks prior to first&#xD;
             administration of study drugs;&#xD;
&#xD;
          -  3. Received major surgery or had significant trauma within 4 weeks prior to first&#xD;
             administration of study drug;&#xD;
&#xD;
          -  4. Received systemic corticosteroids or other immunosuppressors within 14 days prior&#xD;
             to first administration of study drug;&#xD;
&#xD;
          -  5. Patients with AEs from previous treatment that have not recovered to ≤1 (CTCAE 5.0&#xD;
             );&#xD;
&#xD;
          -  6. Patients have central nervous system (CNS) metastasis or meningeal metastasis, or&#xD;
             other evidences which demonstrate the CNS metastasis or meningeal metastasis are not&#xD;
             controlled, resulting that patients are not eligible for enrollment at the&#xD;
             investigator's discretion;&#xD;
&#xD;
          -  7. Patients with any active infection which requires systemic treatment with of&#xD;
             anti-infection currently;&#xD;
&#xD;
          -  8. Patients with medical history of immune deficiency;&#xD;
&#xD;
          -  9. Patients with hepatitis B;&#xD;
&#xD;
          -  10.Patients with HCV infection but who with the HCV-RNA lower than the lower limit of&#xD;
             detection can be enrolled ;&#xD;
&#xD;
          -  11.Patients with interstitial lung disease or Pulmonary function abnormalities which&#xD;
             were identified by the investigator as clinically significant;&#xD;
&#xD;
          -  12.Patients who received any anti-CLDN18.2 treatment;&#xD;
&#xD;
          -  13.Patients with significant medical history of cardiovascular and cerebrovascular&#xD;
             diseases;&#xD;
&#xD;
          -  14.Patient with high risks of gastrointestinal hemorrhage at the investigator's&#xD;
             discretion;&#xD;
&#xD;
          -  15.Patients who need long-term use of non-steroidal anti-inflammatory drugs (NSAIDs) ;&#xD;
&#xD;
          -  16.Known alcohol use or drug dependence;&#xD;
&#xD;
          -  17.Patients with mental disorders or poor compliance;&#xD;
&#xD;
          -  18.Pregnant or lactating women;&#xD;
&#xD;
          -  19.Past severe allergic reactions or allergies to known components of AB011 injection&#xD;
             ;&#xD;
&#xD;
          -  20.Persistent recurrent vomiting (defined as ≥3 vomiting in 24 hours);&#xD;
&#xD;
          -  21. Have other uncured malignant tumors in the past 5 years or at the same time,&#xD;
             except cervical carcinoma in situ, basal cell carcinoma of the skin and other tumors&#xD;
             with very low malignant degree;&#xD;
&#xD;
          -  22.Live attenuated vaccine was administered within 4 weeks prior to initial&#xD;
             administration of the study drug;&#xD;
&#xD;
          -  23.Patients who with other serious systemic diseases or cannot participate in this&#xD;
             trial due to other reasons, at the investigator's discretion.&#xD;
&#xD;
        Stage 2:&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  1. Aged 18 to 80 years, either sex;&#xD;
&#xD;
          -  2. Patients with histologically or cytologic confirmed advanced gastric/oesophagus-&#xD;
             gastric junction cancer or pancreatic cancer without systemic therapy (neoadjuvant&#xD;
             therapy or postoperative adjuvant therapy, no tumor progression or recurrence within 6&#xD;
             months of last medication)&#xD;
&#xD;
          -  3. Tumor tissue samples is CLDN18.2 positive ;&#xD;
&#xD;
          -  4. According to RECIST1.1, there are at least one evaluable tumor lesion during dose&#xD;
             escalation period (stage 1), and at least one measurable tumor lesion during dose&#xD;
             expansion period (stage 2);&#xD;
&#xD;
          -  5. The ECOG score is 0 to 1;&#xD;
&#xD;
          -  6. Expected survival &gt; 3 months;&#xD;
&#xD;
          -  7. Various organs in good condition;&#xD;
&#xD;
          -  8. Fertile eligible patients (male and female) and their partners are willing to use a&#xD;
             reliable method of contraception (hormones, barriers or abstinence) during the study&#xD;
             and within 90 days after the last study treatment; women of childbearing potential&#xD;
             must be tested for serum or urine pregnancy within 7 days before enrollment with&#xD;
             negative results;&#xD;
&#xD;
          -  9. Patients are informed of this study before the trial and sign written informed&#xD;
             consent form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  1. Received any other unmarketed investigational drug within 4 weeks prior to initial&#xD;
             use of the investigational drug;&#xD;
&#xD;
          -  2. Patients with gastric adenocarcinoma and gastric cancer/esophagogastric junction&#xD;
             adenocarcinoma have allergies, intolerations, contraindications or other unsuitable&#xD;
             applications of capecitabine or oxaliplatin regimen (such as complete lack of known&#xD;
             dihydropyrimidine dehydrogenase activity, etc.);Subjects with pancreatic cancer have&#xD;
             allergies, intolerations, contraindications, or other inappropriate use of&#xD;
             gemcitabine, other drugs or any of the components that may be used in the&#xD;
             albumin-bound paclitaxel regimen;&#xD;
&#xD;
          -  3. If the patient has received local treatment such as radiotherapy for locally&#xD;
             advanced unresectable or metastatic gastric/oesophagogastric junction cancer or&#xD;
             pancreatic cancer, unless the treatment was completed &gt;28 days before the first&#xD;
             administration of the study drug.Patients who received palliative radiotherapy with&#xD;
             peripheral bone metastases and recovered from all acute toxicity ≥ 14 days prior to&#xD;
             initial administration of the study therapy were eligible for inclusion;&#xD;
&#xD;
          -  4. Patients with gastric/oesophagogastric junction carcinoma are known to have grade&#xD;
             ≥2 peripheral sensory neuropathy, unless loss of deep tendon reflex is the only&#xD;
             neurological abnormality;&#xD;
&#xD;
          -  5. Major organ surgery (excluding needle biopsy) or significant trauma within 4 weeks&#xD;
             prior to initial use of the study drug;&#xD;
&#xD;
          -  6.Received systemic glucocorticoid (prednisone &gt; 10mg/ day or equivalent dose of the&#xD;
             same drug) or other immunosuppressant treatment within 14 days prior to initial use of&#xD;
             the study drug; The exceptions are: local, ocular, intraarticular, intranasal, and&#xD;
             inhaled glucocorticoids;Short-term use of glucocorticoids for prophylactic treatment&#xD;
             (e.g. to prevent contrast allergy);&#xD;
&#xD;
          -  7.Patients with AEs from previous treatment that have not recovered to ≤1(CTCAE 5.0）;&#xD;
&#xD;
          -  8. Patients have central nervous system (CNS) metastasis or meningeal metastasis, or&#xD;
             other evidences which demonstrate the CNS metastasis or meningeal metastasis are not&#xD;
             controlled, resulting that patients are not eligible for enrollment at the&#xD;
             investigator's discretion;&#xD;
&#xD;
          -  9. Patients with any active infection which requires systemic treatment with of&#xD;
             anti-infection currently;&#xD;
&#xD;
          -  10. Patients with medical history of immune deficiency, Including positive HIV&#xD;
             antibodies;&#xD;
&#xD;
          -  11. Patients with hepatitis B;&#xD;
&#xD;
          -  12.Patients with HCV infection but who with the HCV-RNA lower than the lower limit of&#xD;
             detection can be enrolled ;&#xD;
&#xD;
          -  13.Patients who have interstitial lung disease or Pulmonary function abnormalities&#xD;
             which were identified by the investigator as clinically significant;&#xD;
&#xD;
          -  14.Patients received any anti-CLDN18.2 treatment;&#xD;
&#xD;
          -  15.Patients with have significant medical history of cardiovascular and&#xD;
             cerebrovascular diseases;&#xD;
&#xD;
          -  16.Patient with high risks of gastrointestinal hemorrhage at the investigator's&#xD;
             discretion;&#xD;
&#xD;
          -  17.Patients who need long-term use of non-steroidal anti-inflammatory drugs (NSAIDs) ;&#xD;
&#xD;
          -  18.Known alcohol use or drug dependence;&#xD;
&#xD;
          -  19.Patients with mental disorders or poor compliance;&#xD;
&#xD;
          -  20.Pregnant or lactating women;&#xD;
&#xD;
          -  21.Past severe allergic reactions or allergies to known components of AB011 injection;&#xD;
&#xD;
          -  22.Persistent recurrent vomiting (defined as ≥3 vomiting in 24 hours);&#xD;
&#xD;
          -  23. Have other uncured malignant tumors in the past 5 years or at the same time,&#xD;
             except cervical carcinoma in situ, basal cell carcinoma of the skin and other tumors&#xD;
             with very low malignant degree;&#xD;
&#xD;
          -  24.Live attenuated vaccine was administered within 4 weeks prior to initial&#xD;
             administration of the study drug;&#xD;
&#xD;
          -  25.Patients have other serious systemic diseases or cannot participate in this trial&#xD;
             due to other reasons, at the investigator's discretion.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jin Li</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shanghai East Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Anhui Provincial Hospital</name>
      <address>
        <city>Hefei</city>
        <state>Anhui</state>
        <zip>230036</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beijing Cancer Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100142</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Harbin Medical University Cancer Hospital</name>
      <address>
        <city>Harbin</city>
        <state>Heilongjiang</state>
        <zip>150081</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Henan Cancer Hospital</name>
      <address>
        <city>Zhengzhou</city>
        <state>Henan</state>
        <zip>450003</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Zhengzhou University</name>
      <address>
        <city>Zhengzhou</city>
        <state>Henan</state>
        <zip>450052</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Xiangya Hospital Central South University</name>
      <address>
        <city>Changsha</city>
        <state>Hunan</state>
        <zip>410008</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Huaihua Second People's Hospital</name>
      <address>
        <city>Huaihua</city>
        <state>Hunan</state>
        <zip>418099</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Linyi Cancer Hospital</name>
      <address>
        <city>Linyi</city>
        <state>Shandong</state>
        <zip>276002</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zhongshan Hospital, Zhongshan University</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200032</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shanghai East Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200123</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital, Zhejiang University</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310003</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sir Run Run Shaw Hospital</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310016</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>May 18, 2020</study_first_submitted>
  <study_first_submitted_qc>May 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 22, 2020</study_first_posted>
  <last_update_submitted>January 4, 2023</last_update_submitted>
  <last_update_submitted_qc>January 4, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>advanced solid tumors</keyword>
  <keyword>Gastric Cancer</keyword>
  <keyword>Esophagogastric Junction Cancer</keyword>
  <keyword>Pancreatic Adenocarcinoma</keyword>
  <keyword>Claudin 18.2</keyword>
  <keyword>CLDN18.2</keyword>
  <keyword>monoclonal antibody</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adenocarcinoma</mesh_term>
    <mesh_term>Stomach Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Antineoplastic Agents, Immunological</mesh_term>
    <mesh_term>Antibodies</mesh_term>
    <mesh_term>Immunoglobulins</mesh_term>
    <mesh_term>Antibodies, Monoclonal</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT04400383
org study id: AB011-ST-01
nct id: NCT04400383
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is an open, two-stage, phase I study to evaluate the safety, tolerability,
      pharmacokinetics and preliminary efficacy of AB011 injection in patients with
      CLDN18.2-positive advanced solid tumors.
This study is an open, two-stage, phase I study to evaluate the safety, tolerability,
      pharmacokinetics and preliminary efficacy of AB011 injection in patients with
      CLDN18.2-positive advanced solid tumors. The study is composed of two stages: stage I is
      single treatment and stage II is combo treatment.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Stage1：Incidence of adverse events AE of single and multiple dose (according to NCI CTCAE 5.0)
time frame: From First dose to last patient progression or 6 months, whichever came first
description: An AE or SAE is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
measure: Stage1：Incidence of adverse events SAE of single and multiple dose (according to NCI CTCAE 5.0)
time frame: From First dose to last patient progression or 6 months, whichever came first
description: An AE or SAE is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
measure: Stage 1: The incidence and case number of DLT (Dose Limiting Toxicity) during observation period
time frame: From first dose up to 28 days
description: DLT is short for Dose Limiting Toxicity. dose-limiting describes side effects of a drug or other treatment that are serious enough to prevent an increase in dose or level of that treatment.
measure: Stage 2：Incidence of adverse events AE of single and multiple dose for AB011 combinate with XELOX or Gem/nab-P (according to NCI CTCAE 5.0)
time frame: From First dose to last patient progression or 12 months, whichever came first
description: An AE or SAE is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
measure: Stage 2：Incidence of adverse events SAE of single and multiple dose for AB011 combinate with XELOX or Gem/nab-P (according to NCI CTCAE 5.0)
time frame: From First dose to last patient progression or 12 months, whichever came first
description: An AE or SAE is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
measure: Stage 2: The incidence and case number of DLT (Dose Limiting Toxicity) during observation period
time frame: From first dose up to 21 days
description: DLT is short for Dose Limiting Toxicity. dose-limiting describes side effects of a drug or other treatment that are serious enough to prevent an increase in dose or level of that treatment.
measure: Stage 1: Pharmacokinetics: Area Under Curve (AUC) with immunoanalytical method
time frame: Up to progression of disease after injection, or end of 6 cycle( each cycle is 28 days), whichever came first
description: AUC will be recorded from the PK serum samples collected.
measure: Stage 2: Pharmacokinetics: Area Under Curve (AUC) with immunoanalytical method
time frame: Up to progression of disease after injection, or end of cycle 6 (each cycle is 21 days), whichever came first
description: AUC will be recorded from the PK serum samples collected.
measure: Stage 1: Pharmacokinetics: clearance rate (CL) with immunoanalytical method
time frame: Up to progression of disease after injection, or 6 cycle( dose increase), 8 cycle (dose extension), whichever came first
description: AUC will be recorded from the PK serum samples collected.
measure: Stage 2: Pharmacokinetics: clearance rate (CL) with immunoanalytical method
time frame: Up to progression of disease after injection, or end of cycle 6 (each cycle is 21 days), whichever came first
description: AUC will be recorded from the PK serum samples collected.
measure: Stage 1: Pharmacokinetics: minimum concentration (Cmin) with immunoanalytical method
time frame: Up to progression of disease after injection, or end of cycle 6（dose increase stage), or cycle 8 (dose expansion stage), each cycle is 28 days, whichever came first
description: AUC will be recorded from the PK serum samples collected.
measure: Stage 2: Pharmacokinetics: minimum concentration (Cmin) with immunoanalytical method
time frame: Up to progression of disease after injection, or end of cycle 6 (each cycle is 21 days), whichever came first
description: AUC will be recorded from the PK serum samples collected.
measure: Stage 1: Pharmacokinetics: maximum concentration (Cmax) with immunoanalytical method
time frame: Up to progression of disease after injection, or end of cycle 6（dose increase stage), or cycle 8 (dose expansion stage), each cycle is 28 days, whichever came first
description: AUC will be recorded from the PK serum samples collected.
measure: Stage 2: Pharmacokinetics: maximum concentration (Cmax) with immunoanalytical method
time frame: Up to progression of disease after injection, or end of cycle 6 (each cycle is 21 days), whichever came first
description: AUC will be recorded from the PK serum samples collected.
measure: Stage 1: Pharmacokinetics: half-life (T1/2) with immunoanalytical method
time frame: Up to progression of disease after injection, or end of cycle 6（dose increase stage), or cycle 8 (dose expansion stage), each cycle is 28 days, whichever came first
description: AUC will be recorded from the PK serum samples collected.
measure: Stage 2: Pharmacokinetics: half-life (T1/2) with immunoanalytical method
time frame: Up to progression of disease after injection, or end of cycle 6 (each cycle is 21 days), whichever came first
description: AUC will be recorded from the PK serum samples collected.
measure: Stage 1: volume of distribution (Vd) with immunoanalytical method
time frame: Up to progression of disease after injection, or end of cycle 6（dose increase stage), or cycle 8 (dose expansion stage), each cycle is 28 days, whichever came first
description: AUC will be recorded from the PK serum samples collected.
measure: Stage 2: volume of distribution (Vd) with immunoanalytical method
time frame: Up to progression of disease after injection, or end of cycle 6 (each cycle is 21 days), whichever came first
description: AUC will be recorded from the PK serum samples collected.
measure: Immunogenicity
time frame: Up to 8 months (end of treatment)
description: Incidence of anti-drug antibodies
measure: Efficacy: objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
time frame: Up to progression of disease after injection, or 6 months( stage 1), 12 months (stage 2) whichever came first
description: These measure are defined as the proportion of subjects with complete or partial objective response based on RECIST V1.1.
measure: Efficacy: disease control rate (DCR) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
time frame: Up to progression of disease after injection, or 6 months( stage 1), 12 months (stage 2) whichever came first
description: These measure are defined as the proportion of subjects with complete or partial objective response based on RECIST V1.1.
measure: Efficacy: duration of response (DOR) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
time frame: Up to progression of disease after injection, or 6 months( stage 1), 12 months (stage 2) whichever came first
description: These measure are defined as the proportion of subjects with complete or partial objective response based on RECIST V1.1.
measure: Efficacy: progression free survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
time frame: Up to progression of disease after injection, or 6 months( stage 1), 12 months (stage 2) whichever came first
description: These measure are defined as the proportion of subjects with complete or partial objective response based on RECIST V1.1.
measure: Efficacy: overall survival (OS) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
time frame: Up to progression of disease after injection, or 6 months( stage 1), 12 months (stage 2) whichever came first
description: These measure are defined as the proportion of subjects with complete or partial objective response based on RECIST V1.1.
arm group label: AB011 Injection
arm group type: Experimental
description: AB011 Injection treatment. This phase 1 trial will include two stages, a single treatment stage and a Combo treatment stage.
intervention type: Drug
intervention name: AB011 Injection
description: Stage 1 Single treatment: AB011 Injection with dose escalation of 1mg/kg up to 40mg/kg, as well as dose expansion with recommended dose level from dose escalation.
Stage 2 Combo Treatment: AB011 combine XELOX( GC) or Gem/nab-P (PC) Injection with dose escalation of 10mg/kg up to 30mg/kg, as well as dose expansion with recommended dose level from dose escalation.
arm group label: AB011 Injection
other name: recombinant humanized anti-Claudin 18.2 monoclonal antibody injection
other name: recombinant humanized anti-CLDN 18.2 monoclonal antibody injection
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Jin Li
role: Principal Investigator
affiliation: Shanghai East Hospital
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
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country: China
responsible party type: Sponsor
mesh term: Adenocarcinoma
mesh term: Stomach Neoplasms
mesh term: Antineoplastic Agents, Immunological
mesh term: Antibodies
mesh term: Immunoglobulins
mesh term: Antibodies, Monoclonal
sharing ipd: No