<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/NCT04495296</url>
  </required_header>
  <id_info>
    <org_study_id>TST001-1002</org_study_id>
    <nct_id>NCT04495296</nct_id>
  </id_info>
  <brief_title>A Trial to Evaluate Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of TST001 in Advanced or Metastatic Solid Tumors</brief_title>
  <official_title>A Phase I/IIa Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of TST001 - Claudin18.2 Monoclonal Antibody in the Treatment of Locally Advanced or Metastatic Solid Tumors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Suzhou Transcenta Therapeutics Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Bristol-Myers Squibb</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Suzhou Transcenta 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-label, multi-center, Phase I trial of TST001. Subjects with locally advanced&#xD;
      or metastatic solid tumors will be enrolled. The study will consist of two parts: Part A is&#xD;
      dose escalation and dose expansion phase for mono-therapy, and Part B is dose escalation and&#xD;
      dose expansion phase for combination therapy in gastric, gastroesophageal junction(G/GEJ) and&#xD;
      biliary tract cancer, etc.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      There are two parts in the study. Part I is mono-therapy dose escalation and dose expansion&#xD;
      study, and Part II is dose escalation and dose expansion study of combination therapy.&#xD;
&#xD;
      The dose escalation study will be conducted utilizing 3+3 design with two dosing regimens,&#xD;
      i.e. &quot;once every 2 weeks (Q2W)&quot; and &quot;once every 3 weeks (Q3W)&quot;.&#xD;
&#xD;
      After MTD/RP2D determined, three cohorts may be included in the expansion plan, with about 30&#xD;
      (20-40) subjects with positive CLDN18.2 expression be treated in each cohort, as shown below&#xD;
      (during the study, the treatment cohorts may be adjusted or added based on the clinical and&#xD;
      pre-clinical study data).&#xD;
&#xD;
      Approximately 320-540 treated subjects in total&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 13, 2020</start_date>
  <completion_date type="Anticipated">April 1, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Participant Safety as characterized by frequency and severity of adverse events(according to NCI CTCAE 5.0).</measure>
    <time_frame>up to 30 days following last dose.</time_frame>
    <description>An AE 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>Maximum Tolerated Dose (MTD）</measure>
    <time_frame>up to 28 days following first dose</time_frame>
    <description>The maximum tolerated dose (MTD) is commonly estimated to be the maximum dose that can be determined through DLT of two among 6 subjects administered with TST001 Q2W in 28 days cycles.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum Tolerated Dose (MTD）</measure>
    <time_frame>up to 21days following first dose</time_frame>
    <description>The maximum tolerated dose (MTD) is commonly estimated to be the maximum dose that can be determined through DLT of two among 6 subjects administered with TST001 once every 3 weeks in 21 days cycles.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Recommended Phase 2 Dose (RP2D)</measure>
    <time_frame>up to 30 days following last dose</time_frame>
    <description>The RP2D will be determined during the dose expansion stage of the study. RP2D will be determined using available safety and efficacy data.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The incidence and case number of DLT (Dose Limiting Toxicity) in subjects administered with TST001 Q2W in 28 days cycles during observation period</measure>
    <time_frame>up to 28 days following first dose</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>The incidence and case number of DLT (Dose Limiting Toxicity) in subjects administered with TST001 once every 3 weeks in 21 days cycles during observation period</measure>
    <time_frame>up to 21days following first dose</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>Safety and Tolerability of TST001 in combination with other therapies, e.g. CAPOX, paclitaxel, GP, nivolumab as characterized by frequency and severity of adverse events</measure>
    <time_frame>Up to 30 or 90 days following last dose</time_frame>
    <description>Characterization of TST001 + CAPOX safety profile including frequency and severity of adverse events that are related to treatment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Area under plasma concentration vs time curve (AUC) for TST001</measure>
    <time_frame>up to 30 days following last dose</time_frame>
    <description>Changes in AUC over time in participants with TST001.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peak plasma concentration (Cmax) for TST001</measure>
    <time_frame>up to 30 days following last dose</time_frame>
    <description>Cmax is the maximum plasma concentration.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to maximum observed plasma concentration (Tmax)</measure>
    <time_frame>up to 30 days following last dose</time_frame>
    <description>Tmax is the time in hrs/days it takes to reach Cmax after dosing with TST001</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Terminal elimination half life (t1/2)</measure>
    <time_frame>up to 30 days following last dose</time_frame>
    <description>Time for the plasma level of TST001 to decrease b y 1/2 during the terminal elimination phase.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Immunogenicity</measure>
    <time_frame>up to 30 days following last dose</time_frame>
    <description>by measurement of Incidence of anti-drug antibodies (ADA)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective response rate (ORR)</measure>
    <time_frame>up to 30 days following last dose</time_frame>
    <description>as measured by RECIST 1.1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Response (DOR)</measure>
    <time_frame>up to 30 days following last dose</time_frame>
    <description>DOR is defined as the time from the date of the first response CR (complete remission)/PR (partial remission) (whichever is first recorded) to the date of radiographical progression/death or date of censoring.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease Control Rate</measure>
    <time_frame>up to 30 days following last dose</time_frame>
    <description>DCR: CR+PR+SD</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression free survival (PFS) and OS</measure>
    <time_frame>up to 30 days following last dose</time_frame>
    <description>as measured by RECIST v1.1</description>
  </secondary_outcome>
  <number_of_arms>10</number_of_arms>
  <enrollment type="Anticipated">320</enrollment>
  <condition>Advanced Cancer</condition>
  <arm_group>
    <arm_group_label>dose escalation Q2W</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dosed every 2 weeks IV with TST001, multiple dose levels will be tested.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>dose escalation Q3W</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dosed every 3 weeks IV with TST001, multiple dose levels will be tested.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants with gastric or gastroesophageal junction cancers and CLDN18.2 expression</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants with ductal adenocarcinoma of pancreas and CLDN18.2 expression and CLDN18.2 expression</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort E</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants with advanced or metastatic solid tumors other than G/GEJ adenocarcinoma and CLDN18.2 expression</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort C</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants with HER2 negative or unknown locally advanced or metastatic G/GEJ adenocarcinoma</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort D</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants with locally advanced or metastatic G/GEJ adenocarcinoma</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort F</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants with locally advanced or metastatic biliary tract cancer</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort G</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants with HER2 negative or unknown locally advanced or metastatic G/GEJ adenocarcinoma</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort H (TST001 plus nivolumab)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants with locally advanced or metastatic G/GEJ adenocarcinoma</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>TST001</intervention_name>
    <description>TST001 will be administered by specified doses on specified day</description>
    <arm_group_label>Cohort A</arm_group_label>
    <arm_group_label>Cohort B</arm_group_label>
    <arm_group_label>Cohort C</arm_group_label>
    <arm_group_label>Cohort D</arm_group_label>
    <arm_group_label>Cohort E</arm_group_label>
    <arm_group_label>Cohort F</arm_group_label>
    <arm_group_label>Cohort G</arm_group_label>
    <arm_group_label>Cohort H (TST001 plus nivolumab)</arm_group_label>
    <arm_group_label>dose escalation Q2W</arm_group_label>
    <arm_group_label>dose escalation Q3W</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oxaliplatin</intervention_name>
    <description>Oxaliplatin will be administered by specified doses on specified day</description>
    <arm_group_label>Cohort C</arm_group_label>
    <arm_group_label>Cohort G</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Capecitabine</intervention_name>
    <description>Capecitabine will be administered by specified doses on specified day</description>
    <arm_group_label>Cohort C</arm_group_label>
    <arm_group_label>Cohort G</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Paclitaxel</intervention_name>
    <description>Paclitaxel will be administered by specified doses on specified day</description>
    <arm_group_label>Cohort D</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Gemcitabine</intervention_name>
    <description>Gemcitabine will be administered by specified doses on specified day</description>
    <arm_group_label>Cohort F</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cisplatin</intervention_name>
    <description>Cisplatin will be administered by specified doses on specified days Oxaliplatin will be administered by specified doses on specified day Drug: Capecitabine Capecitabine will be administered by specified doses on specified day</description>
    <arm_group_label>Cohort F</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nivolumab</intervention_name>
    <description>Nivolumab will be administered by specified doses on specified day</description>
    <arm_group_label>Cohort G</arm_group_label>
    <arm_group_label>Cohort H (TST001 plus nivolumab)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        The subjects who meet all inclusion criteria can be enrolled into the trial:&#xD;
&#xD;
          1. Sign the Informed Consent Form (ICF) voluntarily, understand the study and be willing&#xD;
             and able to comply with all study procedures;&#xD;
&#xD;
          2. Male or female ≥ 18 years at signing the ICF;&#xD;
&#xD;
          3. Suffer from histologically confirmed locally unresectable advanced or metastatic solid&#xD;
             tumors and meet the criteria of corresponding cohort as follows:&#xD;
&#xD;
             Part I - Mono-therapy dose escalation and expansion phase:&#xD;
&#xD;
               1. Mono-therapy dose escalation study: The subjects who have no option of or are&#xD;
                  intolerable to SOC.&#xD;
&#xD;
               2. Mono-therapy dose expansion study: The subjects with positive CDLN18.2 expression&#xD;
                  in tumor tissue (defined as CLDN18.2 membranous staining ≥1+ in ≥10% of tumor&#xD;
                  cells by immunohistochemistry (IHC) in the central laboratory) confirmed by the&#xD;
                  central laboratory at enrollment. The dose expansion study may include the&#xD;
                  following 3 cohorts:&#xD;
&#xD;
             Cohort A: Subjects with G/GEJ adenocarcinoma who have no option of or are intolerable&#xD;
             to SOC; Cohort B: Subjects with ductal adenocarcinoma of pancreas who have no option&#xD;
             of or are intolerable to SOC; Cohort E: Subjects with other locally advanced or&#xD;
             metastatic solid tumors excluding G/GEJ adenocarcinoma (limited to biliary tract&#xD;
             neoplasms, lung adenocarcinoma or colorectal cancer) who have no option of or are&#xD;
             intolerable to SOC; Part II - Dose escalation and expansion phase for combination&#xD;
             medication&#xD;
&#xD;
               1. Dose escalation study of combination medication (dose escalation part):&#xD;
&#xD;
                  Cohort C/G: Subjects with HER2 negative or unknown G/GEJ adenocarcinoma who have&#xD;
                  not received prior systemic chemotherapy. The subjects who have completed&#xD;
                  neoadjuvant or adjuvant chemotherapy within at least 6 months prior to the&#xD;
                  initial dosing of the study can be enrolled.&#xD;
&#xD;
                  Cohort D: The subjects with G/GEJ adenocarcinoma who have received at least prior&#xD;
                  first-line systemic chemotherapy; Cohort F: The subjects with biliary neoplasm&#xD;
                  who have not received prior systematic chemotherapy. The subjects who have&#xD;
                  completed neoadjuvant or adjuvant chemotherapy within at least 6 months prior to&#xD;
                  the initial dosing of the study can be enrolled.&#xD;
&#xD;
                  Cohort H: The subjects with G/GEJ adenocarcinoma who have received at least prior&#xD;
                  second-line systemic chemotherapy;&#xD;
&#xD;
               2. Dose expansion study of combination medication (dose expansion part):&#xD;
&#xD;
             The subjects with positive CDLN18.2 expression in tumor tissue confirmed by the&#xD;
             central laboratory will be enrolled as follows:&#xD;
&#xD;
             Cohort C/G: Subjects with HER2 negative or unknown G/GEJ adenocarcinoma who have not&#xD;
             received prior systemic chemotherapy. The subjects who have completed neoadjuvant or&#xD;
             adjuvant chemotherapy within at least 6 months prior to the initial dosing of the&#xD;
             study can be enrolled.&#xD;
&#xD;
             Cohort D: The subjects with G/GEJ adenocarcinoma who have received at least prior&#xD;
             first-line systemic chemotherapy; Cohort F: The subjects with biliary neoplasm who&#xD;
             have not received prior systematic chemotherapy. The subjects who have completed&#xD;
             neoadjuvant or adjuvant chemotherapy within at least 6 months prior to the initial&#xD;
             dosing of the study can be enrolled.&#xD;
&#xD;
             Cohort H: The subjects with G/GEJ adenocarcinoma who have received at least prior&#xD;
             second-line systemic chemotherapy;&#xD;
&#xD;
          4. ECOG performance status of 0-1;&#xD;
&#xD;
          5. Life expectancy ≥ 3 months;&#xD;
&#xD;
          6. The results of laboratory examinations at screening must meet all the following&#xD;
             criteria:&#xD;
&#xD;
               1. Absolute neutrophil count (ANC) ≥ 1.5×109/L;&#xD;
&#xD;
               2. Absolute white blood cell (WBC) count ≥2.5×109/L;&#xD;
&#xD;
               3. Platelets ≥ 100×109/L;&#xD;
&#xD;
               4. Haemoglobin ≥ 9 g/dL;&#xD;
&#xD;
               5. International normalized ratio (INR) ≤ 1.5 times upper limit of normal (ULN) / or&#xD;
                  activated partial thromboplastin time (APTT) ≤ 1.5 times ULN (for the test&#xD;
                  without anticoagulant);&#xD;
&#xD;
               6. INR ≤ 2.5 times ULN / or APTT ≤ 2.5 times ULN (for the test with anticoagulant);&#xD;
&#xD;
               7. Total bilirubin &lt;= 1.5 x ULN (except participants with Gilbert Syndrome who must&#xD;
                  have a total bilirubin level of &lt; 3.0 mg/dL).;&#xD;
&#xD;
               8. AST and ALT ≤ 2.5 times ULN (≤ 5 times ULN for subjects with hepatic cancer or&#xD;
                  liver metastases); ALT/AST ≤ 3xULN regardless of liver metastasis for cohort G&#xD;
                  and H only;&#xD;
&#xD;
               9. Albumin ≥ 30g/L;&#xD;
&#xD;
              10. Serum creatinine ≤ 1.5 times ULN, or creatinine clearance rate ≥ 60 ml/min&#xD;
                  (creatinine clearance rate will be calculated using Cock-croft-Gault Equation);&#xD;
&#xD;
          7. Male and female of childbearing age should agree to take effective contraception&#xD;
             measures (refer to Appendix 3. Contraception) from signing the ICF till at least 120&#xD;
             days post the last dose of TST001 and other study drugs except nivolumab; female of&#xD;
             childbearing age should agree to take effective contraception measures (refer to&#xD;
             Appendix 3. Contraception) from signing the ICF till at least 5 months post the last&#xD;
             dose of nivolumab; Serum β-HCG test for women of childbearing age within 72 hours&#xD;
             prior to the initial dosing must be negative;&#xD;
&#xD;
          8. (For dose expansion phase only) At least one measurable lesion conforming to per&#xD;
             RECIST v1.1;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        The subjects who meet any one of the following criteria will be excluded from participation&#xD;
        in this study:&#xD;
&#xD;
          1. The subjects with locally advanced or metastatic G/GEJ adenocarcinoma who are supposed&#xD;
             to be enrolled into the combination therapy cohorts with CAPOX and CAPOX+nivolumab&#xD;
             (Cohort C and G) have previously received systemic chemotherapy; and the subjects in&#xD;
             the Cohort G have previously received PD1/PD-L1/CTLA4 antibody treatment. The subjects&#xD;
             will be eligible provided that they have completed neoadjuvant or adjuvant&#xD;
             chemotherapy at least 6 months prior to the initial dosing of the study; The subjects&#xD;
             with locally advanced or metastatic G/GEJ adenocarcinoma who are supposed to be&#xD;
             enrolled into the combination therapy cohort with paclitaxel (Cohort D) have&#xD;
             previously received taxane drugs.&#xD;
&#xD;
          2. The subjects who previously received radiotherapy within 4 weeks prior to the initial&#xD;
             dosing of the investigational drug (the subjects who previously received local&#xD;
             radiotherapy for bone metastases treatment within 4 weeks with the radiotherapy&#xD;
             related AE resolved to ≤ Grade 1 will be eligible);&#xD;
&#xD;
          3. The subjects who previously received other systematic anti-tumor drug therapies within&#xD;
             4 weeks or 5 half-lives prior to the initial dosing of the investigational drug&#xD;
             (whichever is shorter); The medication (such as zoledronic acid) for bone metastases&#xD;
             related events will not influence on the enrollment;&#xD;
&#xD;
          4. The subjects who previously received major surgery (exclusive of aspiration biopsy)&#xD;
             within 8 weeks prior to the initial dosing of the investigational drug, or who are&#xD;
             expected to undergo major surgery, or who are in the conditions such as severe&#xD;
             unhealed wound, trauma, and ulcer;&#xD;
&#xD;
          5. The subjects who previously received targeted CLDN18.2 therapy (including CLDN18.2&#xD;
             monoclonal antibody, ADC, double antibody, CART);&#xD;
&#xD;
          6. The subjects who have previous serious allergic reactions, or are intolerable to the&#xD;
             known component of TST001 or other monoclonal antibodies (including humanized or&#xD;
             chimeric antibodies);&#xD;
&#xD;
          7. The subjects who are known to have immediate or delayed hypersensitivity to, be&#xD;
             intolerable to or be forbidden from any component of the investigational drugs;&#xD;
&#xD;
          8. The subjects who have previous serious allergic reaction or intolerance to taxane&#xD;
             drugs (Cohort D only) or any component of CAPOX (Cohort C and G), PD1 antibody (Cohort&#xD;
             G and H) or GP (Cohort F);&#xD;
&#xD;
          9. The subjects in whom symptoms of brain or leptomeningeal metastases are present;&#xD;
&#xD;
             The subjects with central nerve system (CNS) metastasis who meets the following&#xD;
             conditions can be enrolled:&#xD;
&#xD;
             The subjects with brain metastasis who have not received to any treatment and are&#xD;
             asymptomatic, or who are radiologically stable for at least 8 weeks following&#xD;
             treatment and do not require hormone or anti epilepsy treatment at least within 8&#xD;
             weeks;&#xD;
&#xD;
         10. The subjects with body cavity effusion (hydrothorax, ascites and pericardial effusion)&#xD;
             requiring local treatment or repeated drainage which is not well controlled at the&#xD;
             discretion of the investigators;&#xD;
&#xD;
         11. The subjects with concurrent malignant tumors within 3 years other than adequately&#xD;
             treated cervical carcinoma in situ, localized squamous cell cancer of the skin, basal&#xD;
             cell carcinoma, prostate cancer with no treatment required (with or without&#xD;
             resection), ductal carcinoma in situ of the breast, or ≤ T1 urothelial carcinoma (for&#xD;
             the dose expansion phase only);&#xD;
&#xD;
         12. Any adverse reactions caused by previous treatment have not resolved to ≤ Grade 1 as&#xD;
             per CTCAE v5.0 (exclusive of alopecia and anaemia) before the initial dosing of the&#xD;
             investigational drug. If the adverse reaction has no clinical influence, the Sponsor&#xD;
             and investigators will decide whether the subject can be enrolled in the study after&#xD;
             discussion.&#xD;
&#xD;
         13. The subjects who received growth factor, transfusion or other blood products in&#xD;
             treatment of anaemia or decreased platelet within 14 days prior to the initial dose;&#xD;
&#xD;
         14. The subjects who experienced clinically significant cardiovascular and cerebrovascular&#xD;
             diseases within 6 months before the initial dosing of the investigational drug,&#xD;
             including:&#xD;
&#xD;
             i. Myocardial infarction, ii. Unstable angina pectoris, iii. Cerebrovascular accident&#xD;
             or iv. Other acute uncontrollable cardiovascular diseases; Clinically significant&#xD;
             ventricular arrhythmia history (such as ongoing ventricular tachycardia, ventricular&#xD;
             fibrillation and torsade de pointes); New York Heart Association (NYHA) Class III or&#xD;
             IV congestive cardiac failure; QTc ≥470ms (female) or QTc ≥450ms (male), or medical&#xD;
             history or family history of congenital long-QT syndrome (Naring A, 2012); The&#xD;
             subjects with heart rhythm disorders requiring the treatment with antiarrhythmic drugs&#xD;
             (The subjects who suffer from atrial fibrillation with heart rate controllable more&#xD;
             than 1 month before the initial dosing of the investigational drug will be eligible);&#xD;
&#xD;
         15. The subjects who are known to have dihydropyrimidine dehydrogenase (DPD) deficiency.&#xD;
             (Note: DPD deficiency screening should be performed according to local requirement.)&#xD;
             (The screening will be performed only in the subjects receiving CAPOX.)&#xD;
&#xD;
         16. Subjects with recent gastrointestinal bleeding as evidenced by hematemesis,&#xD;
             hematochezia, or melena in the past 3 months without evidence of resolution documented&#xD;
             by endoscopy or colonoscopy;&#xD;
&#xD;
         17. The subjects who have evidenced risk of gastric haemorrhage or gastric perforation&#xD;
             will be excluded from the study at the discretion of the investigators;&#xD;
&#xD;
         18. The subjects with documented obstruction pyloric and persistent repeated vomiting&#xD;
             defined as ≥ 3 episodes within 24 hours;&#xD;
&#xD;
         19. Documented active colitis within 4 weeks prior to study entry, including infectious&#xD;
             colitis, radiation colitis and ischemic colitis.&#xD;
&#xD;
         20. History of ulcerative colitis or Crohn's disease;&#xD;
&#xD;
         21. Uncontrolled diarrhea is present;&#xD;
&#xD;
         22. The subjects who are known to have &gt; Grade 1 peripheral sensory neuropathy, unless a&#xD;
             lack of deep tendon reflexes is the only neurological abnormality;&#xD;
&#xD;
         23. Active infection requiring systematically intravenous antibiotic therapy within 2&#xD;
             weeks prior to dosing;&#xD;
&#xD;
         24. HIV infection history or positive HIV viral test;&#xD;
&#xD;
         25. The subjects who are known to have the history of hepatitis C or chronic active&#xD;
             hepatitis B;&#xD;
&#xD;
             Except for:&#xD;
&#xD;
               1. HBV virus carriers or subjects with hepatitis B infection that is stable after&#xD;
                  medications (HBV-DNA titer should be no more than 1000 copies [cps]/mL or 200&#xD;
                  IU/mL); Patients who are not currently on viral suppressive therapy may be&#xD;
                  eligible and should be discussed with the Medical Monitor and if enrolled,&#xD;
                  antiviral therapy is required throughout study treatment.&#xD;
&#xD;
               2. Subjects with hepatitis C infection that is stable after medications (HCV-RNA&#xD;
                  test negative);&#xD;
&#xD;
         26. Subjects with active autoimmune disorders requiring systemic immunosuppressive therapy&#xD;
             within the past 2 years (Subjects with type 1 diabetes mellitus (TD1M), hypothyroidism&#xD;
             requiring hormone replacement therapy only, or skin diseases that do not require&#xD;
             systemic treatment are eligible);&#xD;
&#xD;
         27. Any disease requiring systemic treatment with corticosteroids (&gt; 10 mg/day prednisone&#xD;
             or equivalent drugs) or other immunosuppressive drugs for ≤14 days prior to the first&#xD;
             dose of the investigational drug, except for:&#xD;
&#xD;
             Adrenal replacement steroids (≤10 mg/day prednisone or equivalent drugs) Topical,&#xD;
             ophthalmic, intra-articular, intranasal or inhaled corticosteroids with low systemic&#xD;
             absorption Preventive corticosteroids (e.g. prevention of contrast media allergy) for&#xD;
             short term (≤ 7 days), or corticosteroids for the treatment of non-autoimmune&#xD;
             disorders (e.g. delayed type hypersensitivity caused by contactant);&#xD;
&#xD;
         28. Any conditions that the investigators judge that the patient is not appropriate for&#xD;
             PD-1 antibody treatment, including but not limited to a history of interstitial lung&#xD;
             disease or non-infectious pneumonia, uncontrollable lung diseases, such as pulmonary&#xD;
             fibrosis, active pneumonia, etc. (Cohort G and H);&#xD;
&#xD;
         29. Subjects vaccinated live vaccine within 4 weeks before the first dose of the&#xD;
             investigational drug;&#xD;
&#xD;
         30. Pregnant or lactating women;&#xD;
&#xD;
         31. Subject with other conditions (such as psychological, geographic or medical&#xD;
             conditions) that do not allow them to follow the study schedule and follow-up&#xD;
             procedures. Or the subjects who are unsuitable to be enrolled into the study at the&#xD;
             discretion of the investigators.&#xD;
&#xD;
        As of protocol version 4.2, enrollment of subjects on the combination protocol no longer&#xD;
        requires a positive CLDN18.2 expression result, but enrolled subjects must provide&#xD;
        sufficient formalin-fixed paraffin-embedded (FFPE) wax blocks of tumor tissue specimens or&#xD;
        at least 10 consecutive white slices) for retrospective CLDN18.2 and PD-L1 testing.&#xD;
        (Patients may be enrolled if they have less than 10 specimens, but not less than 7, and&#xD;
        meet the requirements of the other inclusion criteria and receive approval from the&#xD;
        sponsor's medical ombudsman).&#xD;
&#xD;
        Other protocol defined inclusion/exclusion criteria could apply&#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>Qian Wu</last_name>
    <phone>860512-67079200</phone>
    <email>Qian.wu@transcenta.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Henry Mao</last_name>
    <phone>860512-67079200</phone>
    <email>henry.mao@transcenta.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Bengbu Medical College</name>
      <address>
        <city>Bengbu</city>
        <state>Anhui</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Fuyou Zhao</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Beijing Cancer Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100036</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>lin Shen</last_name>
      <phone>010-88196340</phone>
      <email>doctorshenlin@sina.cn</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Beijing Friendship Hospital, Capital Medical University</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Bangwei Cao</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Peking Union Medical College Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Lin Zhao</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Peking University International Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Jun Liang</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Chongqing Medical University</name>
      <address>
        <city>Chongqing</city>
        <state>Chongqing</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jun Zhang</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Fujian Cancer Hospital</name>
      <address>
        <city>Fuzhou</city>
        <state>Fujian</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Zengqing Guo</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Fujian Medical University Union Hospital</name>
      <address>
        <city>Fuzhou</city>
        <state>Fujian</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Chunmei Shi</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Xiamen University</name>
      <address>
        <city>Xiamen</city>
        <state>Fujian</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jiayi Li</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>The Sixth Affiliated Hospital of Sun Yat-sen University</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yanhong Deng</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>The People's Hospital of Guangxi Zhuang Autonomous Region</name>
      <address>
        <city>Guangxi</city>
        <state>Guangxi</state>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Kehe Chen</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hainan Provincial People's Hospital</name>
      <address>
        <city>Haikou</city>
        <state>Hainan</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lin Wang</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Zhengzhou University</name>
      <address>
        <city>Zhengzhou</city>
        <state>Heibei</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Qingxia Fan</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Harbin Medical University Cancer Hospital</name>
      <address>
        <city>Ha'erbin</city>
        <state>Heilongjiang</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yuxian Bai</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Henan Cancer Hospital</name>
      <address>
        <city>Zhengzhou</city>
        <state>Henan</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ning li</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hubei Cancer Hospital</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Huiting Xu</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Zhongnan Hospital of Wuhan University</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Fuxiang Zhou</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hunan Cancer Hospital</name>
      <address>
        <city>Changsha</city>
        <state>Hunan</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xianli Yin</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Xiangya Hospital, Central South University</name>
      <address>
        <city>Changsha</city>
        <state>Hunan</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Shan Zeng</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Suzhou Municipal Hospital</name>
      <address>
        <city>Suzhou</city>
        <state>Jiangsu</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Feng Guo</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>The Second Affiliated Hospital of Soochow University</name>
      <address>
        <city>Suzhou</city>
        <state>Jiangsu</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Zhixiang Zhuang</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Xuzhou Central Hospital</name>
      <address>
        <city>Xuzhou</city>
        <state>Jiangsu</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Liang Han</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>The Second Affiliated Hospital of Nanchang University</name>
      <address>
        <city>Nanchang</city>
        <state>Jiangxi</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hua Wang</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Jilin Cancer Hospital</name>
      <address>
        <city>Chang chun</city>
        <state>Jilin</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ying Cheng</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>The First Hospital of Jilin University</name>
      <address>
        <city>Chang chun</city>
        <state>Jilin</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Wei Li</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Jinzhou Medical University</name>
      <address>
        <city>Jinzhou</city>
        <state>Liaoning</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Zhitu Zhu</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Liaoning Cancer Hospital &amp; Institute</name>
      <address>
        <city>Shenyang</city>
        <state>Liaoning</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jingdong Zhang</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>The First Hospital of China Medical University</name>
      <address>
        <city>Shenyang</city>
        <state>Liaoning</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xiujuan Qu</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Jinan Central Hospital</name>
      <address>
        <city>Jinan</city>
        <state>Shandong</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Meili Sun</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Linyi Cancer Hospital</name>
      <address>
        <city>Linyi</city>
        <state>Shandong</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jianhua Shi</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>The Affiliated Hospital of Qingdao University</name>
      <address>
        <city>Qingdao</city>
        <state>Shandong</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xiaochun Zhang</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Fudan University Shanghai Cance Center</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>guo weijian</last_name>
      <email>guoweijian1@hotmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Zhongshan Hospital Fudan University</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tianshu Liu</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>West China Hospital, Sichuan University</name>
      <address>
        <city>Chendu</city>
        <state>Sichuan</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dan Cao</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Sichuan Cancer Hospital</name>
      <address>
        <city>Chengdu</city>
        <state>Sichuan</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jin Lu</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Tianjin Medical University Cancer Institute &amp; Hospital</name>
      <address>
        <city>Tianjin</city>
        <state>Tianjin</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hongli Li</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Tianjin Medical University General Hospital</name>
      <address>
        <city>Tianjin</city>
        <state>Tianjin</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Diansheng Zhong</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>First Affiliated Hospital of Zhejiang University</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>nong xu</last_name>
      <phone>0571-87236560</phone>
      <email>xunongclinicltrial@126.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>The Second Affiliated Hospital of Zhejiang University School of Medicine</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ying Yuan</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Zhejiang Cancer Hospital</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Haijun Zhong</last_name>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>July 23, 2020</study_first_submitted>
  <study_first_submitted_qc>July 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 31, 2020</study_first_posted>
  <last_update_submitted>March 27, 2023</last_update_submitted>
  <last_update_submitted_qc>March 27, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 30, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Paclitaxel</mesh_term>
    <mesh_term>Gemcitabine</mesh_term>
    <mesh_term>Capecitabine</mesh_term>
    <mesh_term>Oxaliplatin</mesh_term>
    <mesh_term>Nivolumab</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/NCT04495296
org study id: TST001-1002
nct id: NCT04495296
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is an open-label, multi-center, Phase I trial of TST001. Subjects with locally advanced
      or metastatic solid tumors will be enrolled. The study will consist of two parts: Part A is
      dose escalation and dose expansion phase for mono-therapy, and Part B is dose escalation and
      dose expansion phase for combination therapy in gastric, gastroesophageal junction(G/GEJ) and
      biliary tract cancer, etc.
There are two parts in the study. Part I is mono-therapy dose escalation and dose expansion
      study, and Part II is dose escalation and dose expansion study of combination therapy.

      The dose escalation study will be conducted utilizing 3+3 design with two dosing regimens,
      i.e. "once every 2 weeks (Q2W)" and "once every 3 weeks (Q3W)".

      After MTD/RP2D determined, three cohorts may be included in the expansion plan, with about 30
      (20-40) subjects with positive CLDN18.2 expression be treated in each cohort, as shown below
      (during the study, the treatment cohorts may be adjusted or added based on the clinical and
      pre-clinical study data).

      Approximately 320-540 treated subjects in total
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Participant Safety as characterized by frequency and severity of adverse events(according to NCI CTCAE 5.0).
time frame: up to 30 days following last dose.
description: An AE 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: Maximum Tolerated Dose (MTD）
time frame: up to 28 days following first dose
description: The maximum tolerated dose (MTD) is commonly estimated to be the maximum dose that can be determined through DLT of two among 6 subjects administered with TST001 Q2W in 28 days cycles.
measure: Maximum Tolerated Dose (MTD）
time frame: up to 21days following first dose
description: The maximum tolerated dose (MTD) is commonly estimated to be the maximum dose that can be determined through DLT of two among 6 subjects administered with TST001 once every 3 weeks in 21 days cycles.
measure: Recommended Phase 2 Dose (RP2D)
time frame: up to 30 days following last dose
description: The RP2D will be determined during the dose expansion stage of the study. RP2D will be determined using available safety and efficacy data.
measure: The incidence and case number of DLT (Dose Limiting Toxicity) in subjects administered with TST001 Q2W in 28 days cycles during observation period
time frame: up to 28 days following first dose
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: The incidence and case number of DLT (Dose Limiting Toxicity) in subjects administered with TST001 once every 3 weeks in 21 days cycles during observation period
time frame: up to 21days following first dose
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: Safety and Tolerability of TST001 in combination with other therapies, e.g. CAPOX, paclitaxel, GP, nivolumab as characterized by frequency and severity of adverse events
time frame: Up to 30 or 90 days following last dose
description: Characterization of TST001 + CAPOX safety profile including frequency and severity of adverse events that are related to treatment.
measure: Area under plasma concentration vs time curve (AUC) for TST001
time frame: up to 30 days following last dose
description: Changes in AUC over time in participants with TST001.
measure: Peak plasma concentration (Cmax) for TST001
time frame: up to 30 days following last dose
description: Cmax is the maximum plasma concentration.
measure: Time to maximum observed plasma concentration (Tmax)
time frame: up to 30 days following last dose
description: Tmax is the time in hrs/days it takes to reach Cmax after dosing with TST001
measure: Terminal elimination half life (t1/2)
time frame: up to 30 days following last dose
description: Time for the plasma level of TST001 to decrease b y 1/2 during the terminal elimination phase.
measure: Immunogenicity
time frame: up to 30 days following last dose
description: by measurement of Incidence of anti-drug antibodies (ADA)
measure: Objective response rate (ORR)
time frame: up to 30 days following last dose
description: as measured by RECIST 1.1
measure: Duration of Response (DOR)
time frame: up to 30 days following last dose
description: DOR is defined as the time from the date of the first response CR (complete remission)/PR (partial remission) (whichever is first recorded) to the date of radiographical progression/death or date of censoring.
measure: Disease Control Rate
time frame: up to 30 days following last dose
description: DCR: CR+PR+SD
measure: Progression free survival (PFS) and OS
time frame: up to 30 days following last dose
description: as measured by RECIST v1.1
arm group label: dose escalation Q2W
arm group type: Experimental
description: Dosed every 2 weeks IV with TST001, multiple dose levels will be tested.
arm group label: dose escalation Q3W
arm group type: Experimental
description: Dosed every 3 weeks IV with TST001, multiple dose levels will be tested.
arm group label: Cohort A
arm group type: Experimental
description: Participants with gastric or gastroesophageal junction cancers and CLDN18.2 expression
arm group label: Cohort B
arm group type: Experimental
description: Participants with ductal adenocarcinoma of pancreas and CLDN18.2 expression and CLDN18.2 expression
arm group label: Cohort E
arm group type: Experimental
description: Participants with advanced or metastatic solid tumors other than G/GEJ adenocarcinoma and CLDN18.2 expression
arm group label: Cohort C
arm group type: Experimental
description: Participants with HER2 negative or unknown locally advanced or metastatic G/GEJ adenocarcinoma
arm group label: Cohort D
arm group type: Experimental
description: Participants with locally advanced or metastatic G/GEJ adenocarcinoma
arm group label: Cohort F
arm group type: Experimental
description: Participants with locally advanced or metastatic biliary tract cancer
arm group label: Cohort G
arm group type: Experimental
description: Participants with HER2 negative or unknown locally advanced or metastatic G/GEJ adenocarcinoma
arm group label: Cohort H (TST001 plus nivolumab)
arm group type: Experimental
description: Participants with locally advanced or metastatic G/GEJ adenocarcinoma
intervention type: Drug
intervention name: TST001
description: TST001 will be administered by specified doses on specified day
arm group label: Cohort A
arm group label: Cohort B
arm group label: Cohort C
arm group label: Cohort D
arm group label: Cohort E
arm group label: Cohort F
arm group label: Cohort G
arm group label: Cohort H (TST001 plus nivolumab)
arm group label: dose escalation Q2W
arm group label: dose escalation Q3W
intervention type: Drug
intervention name: Oxaliplatin
description: Oxaliplatin will be administered by specified doses on specified day
arm group label: Cohort C
arm group label: Cohort G
intervention type: Drug
intervention name: Capecitabine
description: Capecitabine will be administered by specified doses on specified day
arm group label: Cohort C
arm group label: Cohort G
intervention type: Drug
intervention name: Paclitaxel
description: Paclitaxel will be administered by specified doses on specified day
arm group label: Cohort D
intervention type: Drug
intervention name: Gemcitabine
description: Gemcitabine will be administered by specified doses on specified day
arm group label: Cohort F
intervention type: Drug
intervention name: Cisplatin
description: Cisplatin will be administered by specified doses on specified days Oxaliplatin will be administered by specified doses on specified day Drug: Capecitabine Capecitabine will be administered by specified doses on specified day
arm group label: Cohort F
intervention type: Drug
intervention name: Nivolumab
description: Nivolumab will be administered by specified doses on specified day
arm group label: Cohort G
arm group label: Cohort H (TST001 plus nivolumab)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Qian Wu
phone: 860512-67079200
email: Qian.wu@transcenta.com
last name: Henry Mao
phone: 860512-67079200
email: henry.mao@transcenta.com
facility: 
status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Not yet recruiting
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status: Not yet recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Not yet recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Paclitaxel
mesh term: Gemcitabine
mesh term: Capecitabine
mesh term: Oxaliplatin
mesh term: Nivolumab
sharing ipd: No