xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05994001</url>
    </required_header>
    <id_info>
      <org_study_id>ZSAB-Calm</org_study_id>
      <nct_id>NCT05994001</nct_id>
    </id_info>
    <brief_title>Candonilimab in Combination With LM-302 for Claudin 18.2 Positive-advanced Biliary Tract Cancer After Failure of Standard of Chemotherapy and PD1/PD-L1 Antibody</brief_title>
    <official_title>Two Stage, Multi-center Trial of Candonilimab in Combination With LM-302 for Treatment of Patients With Claudin 18.2 Positive-advanced Biliary Tract Cancer After Failure of Standard of Chemotherapy and PD1/PD-L1 Antibody</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Shanghai Zhongshan Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Shanghai Zhongshan Hospital</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>
        In this clinical study, we will evaluate the efficacy and safety of cardonilimumab (PD1&#xD;
        monoclonal antibody and CTLA-4 monoclonal antibody bisspecific antibodies) and LM-302&#xD;
        (Claudin18.2-ADC) in Claudin18.2-positive advanced BTC patients who have progressed after SOC&#xD;
        and PD1/PD-L1 monoclonal antibody treatment.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The prognosis for unresectable and metastatic biliary malignancies (BTC) is extremely poor,&#xD;
        with a median overall survival of only about 1 year for advanced biliary tumors treated with&#xD;
        gemcitabine and cisplatin or combined with duvaliumab (PD-L1) as recommended by NCCN&#xD;
        guidelines. At present, the NCCN guidelines recommend that the posterior line treatment of&#xD;
        advanced BTC, such as FOLFOX, has a very limited effect, with an objective response rate of&#xD;
        only about 5% and a median survival time of only about 6 months. There is an urgent need to&#xD;
        develop new therapeutic methods to improve patient survival. Chronic inflammation caused by&#xD;
        viral infection and bile duct stones are the most common potential risk factors for BTC, and&#xD;
        immune system abnormalities play a key role in the occurrence and development of BTC. BTC,&#xD;
        including intrahepatic cholangiocarcinoma (iCCA), showed abnormal expression of immune&#xD;
        checkpoint molecules PD-L1 and CTLA-4 and obvious heterogeneity. Therefore, immunotherapy is&#xD;
        of great value. TOPAZ-1 and KENOTE-966 studies both showed the value of PD-L1/PD1 monoclonal&#xD;
        antibody in the treatment of advanced BTC. There is currently a lack of treatment options for&#xD;
        progression after treatment with standard chemotherapy (SOC) combined with PD-L1/PD1&#xD;
        monoclonal antibodies. CTLA-4 inhibitors combined with PD-1/PD-L1 inhibitors have shown&#xD;
        significantly enhanced clinical effects. Clinical studies on treating CTLA-4 inhibitors&#xD;
        combined with PD-1/PD-L1 inhibitors have been carried out in several solid tumors. Although&#xD;
        significant therapeutic effects have been achieved, adverse reactions (AEs) that cannot be&#xD;
        ignored limit the benefit of patients. Claudin18.2 is a newly discovered tumor therapeutic&#xD;
        target. Multiple clinical studies have shown that Claudin18.2 monoclonal antibody,&#xD;
        Claudin18.2-ADC, and Cart-Claudin18.2 have good ORR in Claudin18.2-positive gastric cancer.&#xD;
        At present, no independent research data on advanced BTC has been reported.&#xD;
  &#xD;
        In this clinical study, we will evaluate the efficacy and safety of cardonilimumab (PD1&#xD;
        monoclonal antibody and CTLA-4 monoclonal antibody bispecific antibodies) and LM-302&#xD;
        (Claudin18.2-ADC) in Claudin18.2-positive advanced BTC patients who have progressed after SOC&#xD;
        and PD1/PD-L1 monoclonal antibody treatment.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 1, 2023</start_date>
    <completion_date type="Anticipated">August 1, 2026</completion_date>
    <primary_completion_date type="Anticipated">August 1, 2025</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>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>Each cycle of the first phase was defined as cardonilizumab (6mg/kg,Q2W) combined with different concentrations of 1.6mg/kg or 1.8mg/kg LM-302 (Q2W), 14 days as a course of treatment, and the combined dose (RP2D) of LM-302 during combination therapy was determined according to the 3+3 design.&#xD;
  In the second phase, Claudin18.2 expression was positive, and the positive population was randomly assigned to trial group 1, trial group 2, and trial group 3.&#xD;
  Group 1:6 mg/kg cardonilizumab, 14 days for 1 course. Group 2:1.8mg /mg LM-302 was treated for 1 course for 14 days. Group 3: 6 mg/kg cardonilizumab for 14 days was a course of treatment; RP2D LM-302 is 1 course of treatment for 14 days.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Participant)</masking>
      <masking_description>Each cycle of the first phase was defined as cardonilizumab (6mg/kg,Q2W) combined with different concentrations of 1.6mg/kg or 1.8mg/kg LM-302 (Q2W), 14 days as a course of treatment, and the combined dose (RP2D) of LM-302 during combination therapy was determined according to the 3+3 design.&#xD;
  In the second phase, Claudin18.2 expression was positive, and the positive population was randomly assigned to trial group 1, trial group 2, and trial group 3.&#xD;
  Group 1:6 mg/kg cardonilizumab, 14 days for 1 course. Group 2:1.8mg /mg LM-302 was treated for 1 course for 14 days. Group 3: 6 mg/kg cardonilizumab for 14 days was a course of treatment; RP2D LM-302 is 1 course of treatment for 14 days.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>ORR(Phase II)</measure>
      <time_frame>24months</time_frame>
      <description>Objective response rate (ORR) in patients with Claudin18.2-positive treated with cardonillizumab combined with LM302 (RECIST 1.1)(Phase II)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Incidence of Treatment-Emergent Adverse Events(Phase I)</measure>
      <time_frame>24months</time_frame>
      <description>Safety of cardonilizumab in combination with different doses of LM-302 in patients with advanced BTC</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>DOR</measure>
      <time_frame>24months</time_frame>
      <description>duration of overall response</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>DCR</measure>
      <time_frame>24months</time_frame>
      <description>disease control rate</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>OS</measure>
      <time_frame>24months</time_frame>
      <description>Overall survival</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">96</enrollment>
    <condition>Biliary Tract Cancer</condition>
    <condition>Candonilimab</condition>
    <condition>Claudin 18.2</condition>
    <arm_group>
      <arm_group_label>Group 1</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>6 mg/kg cardonilizumab, 14 days for 1 course.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group 2</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>1.8mg /mg LM-302 was treated for 1 course for 14 days.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group 3</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>6 mg/kg cardonilizumab for 14 days was a course of treatment; RP2D LM-302 is 1 course of treatment for 14 days</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>cardonilizumab</intervention_name>
      <description>cardonilizumab:PD1 and CTLA-4 bispecific antibody</description>
      <arm_group_label>Group 1</arm_group_label>
      <arm_group_label>Group 3</arm_group_label>
      <other_name>PD1 and CTLA-4 bispecific antibody</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>LM-302</intervention_name>
      <description>LM-302 :ClAUDIN 18.2-ADC</description>
      <arm_group_label>Group 2</arm_group_label>
      <arm_group_label>Group 3</arm_group_label>
      <other_name>ClAUDIN 18.2-ADC</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Advanced BTC that is not resectable or metastatic or recurred after surgery,&#xD;
               histologically confirmed, and sufficient tissue specimens are provided for PD-L1,&#xD;
               CTLA-4, Claudin18.2 immunohistochemistry and exon sequencing. Claudin18.2 expression&#xD;
               is not required at the first stage. In the second stage, Claudin18.2-positive patients&#xD;
               were required to be enrolled (≥40% immunohistochemical expression of Claudin18.2 was&#xD;
               considered positive, &lt;40% was considered negative, and two independent pathologists&#xD;
               made the judgment. If there was any discrepancy, the third pathologist was asked to&#xD;
               make the judgment together).&#xD;
  &#xD;
            2. Failure of standard chemotherapy (gemcitabine or platinum or fluorouracil) and&#xD;
               PD1/PD-L1 for advanced BTC due to disease progression or toxicity;&#xD;
  &#xD;
            3. Measurable lesions;&#xD;
  &#xD;
            4. For patients with a prior history of hepatic chemoembolization, radiofrequency&#xD;
               ablation/intervention, or radiotherapy, measurable lesions outside the&#xD;
               chemoembolization or radiotherapy area or measurable progression lesions at the&#xD;
               chemoembolization or radiotherapy site must be present;&#xD;
  &#xD;
            5. ECOG physical state ≤ 2;&#xD;
  &#xD;
            6. Life expectancy &gt; 3 months;&#xD;
  &#xD;
            7. Adequate renal function: creatinine (Cr) ≤ 1.5 × upper limit of normal (ULN) or&#xD;
               glomerular filtration rate (GFR) ≥ 60mL/min/ 1.73m2;&#xD;
  &#xD;
            8. Adequate liver function: bilirubin ≤ 1.5 × ULN and alanine aminotransferase (ALT) and&#xD;
               aspartate aminotransferase (AST) ≤ 2.5 × ULN;&#xD;
  &#xD;
            9. Adequate bone marrow reserve: absolute value of neutrophil (ANC) &gt; 1500/mcl, platelets&#xD;
               (Plts) &gt; 75,000/mcl, hemoglobin (Hgb) ≥ 9.0g/dl;&#xD;
  &#xD;
           10. Prothrombin time/activated partial thromboplastin time (PT/PTT) &lt;1.5 × ULN;&#xD;
  &#xD;
           11. Age ≥18 years old, male or female;&#xD;
  &#xD;
           12. Participants with a prior history or persistent hepatitis C virus (HCV) infection will&#xD;
               be eligible to participate in the study. Participants receiving antiviral therapy must&#xD;
               complete treatment at least 1 month before the start of the study intervention. For&#xD;
               HCV subjects who have not received or have not completed antiviral therapy, treatment&#xD;
               should be initiated only after liver function has remained stable for at least 3&#xD;
               months during the study intervention.&#xD;
  &#xD;
           13. Hepatitis B controlled subjects are eligible to participate in the study as long as&#xD;
               they meet the following criteria:&#xD;
  &#xD;
               Subjects with chronic hepatitis B virus (HBV) infection (defined as hepatitis B&#xD;
               surface antigen [HBsAg] positive and/or detectable HBV DNA) must have a HBV viral load&#xD;
               of less than 2000 IU/ml prior to first dosing of the study intervention or a 10-fold&#xD;
               reduction in HBV viral load with antiviral therapy. Subjects treated with active HBV&#xD;
               with a viral load below 2000 IU/ml should receive antiviral therapy throughout the&#xD;
               study intervention.&#xD;
  &#xD;
           14. Subjects who are clinically cured of HBV infection (defined as HBsAg negative and&#xD;
               anti-HBC positive) and whose HBV viral load is not detectable at screening should have&#xD;
               their HBV viral load checked every 8 weeks and should be treated for HBV if the viral&#xD;
               load exceeds 2000 IU/ml. Antiviral therapy after completion of the study intervention&#xD;
               should follow local guidelines.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  1) Previous treatment with checkpoint inhibitor CTLA-4 monoclonal antibody, targeting&#xD;
               Claudin18.2; 2) Major surgery or radiotherapy or intervention or ablation within 4&#xD;
               weeks before enrollment; 3) Active, known, or suspected autoimmune disease; 4)&#xD;
               Congestive heart failure or symptomatic coronary artery disease within 3 months prior&#xD;
               to enrollment; 5) Cerebrovascular accident occurred within the past 6 months; 6)&#xD;
               Clinically significant bleeding, bleeding event, or thromboembolic disease within 6&#xD;
               months; 7) History of intestinal perforation; 8) Have a history of (non-infectious)&#xD;
               pneumonia requiring steroid treatment or currently have pneumonia; 9) Known history of&#xD;
               human immunodeficiency virus (HIV) infection; 10) A history of severely impaired lung&#xD;
               function or interstitial lung disease; 11) Concurrent malignancies (other than&#xD;
               adequately treated non-melanoma skin cancer, superficial transitional cell carcinoma&#xD;
               of the bladder and cervical carcinoma in situ [CIS]) or any currently active&#xD;
               malignancies have been diagnosed within the last 5 years; 12) Past or current evidence&#xD;
               indicates any condition, treatment, or laboratory abnormality that may confuse the&#xD;
               study results, interfere with the subject's participation throughout the study, or the&#xD;
               investigator determines that participation in the study is not in the subject's best&#xD;
               interest.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Jia Fan, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Fudan University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Guo-Ming Shi, MD</last_name>
      <phone>+86-13916969578</phone>
      <email>shi.guoming@zs-hospital.sh.cn</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Xiao-Yong Huang, MD</last_name>
      <phone>+86-15021519215</phone>
      <email>huang.xiaoyong@zs-hospital.sh.cn</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Zhongshan hospital, Fudan University</name>
        <address>
          <city>Shanghai</city>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Guo-Ming Shi, MD</last_name>
        <phone>+8613916969578</phone>
        <email>shi.guoming@zs-hospital.sh.cn</email>
      </contact>
      <contact_backup>
        <last_name>Xiao-Yong Huang, MD</last_name>
        <phone>+8615021519215</phone>
        <email>huang.xiaoyong@zs-hospital.sh.cn</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <reference>
      <citation>Kelley RK, Ueno M, Yoo C, Finn RS, Furuse J, Ren Z, Yau T, Klumpen HJ, Chan SL, Ozaka M, Verslype C, Bouattour M, Park JO, Barajas O, Pelzer U, Valle JW, Yu L, Malhotra U, Siegel AB, Edeline J, Vogel A; KEYNOTE-966 Investigators. Pembrolizumab in combination with gemcitabine and cisplatin compared with gemcitabine and cisplatin alone for patients with advanced biliary tract cancer (KEYNOTE-966): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2023 Jun 3;401(10391):1853-1865. doi: 10.1016/S0140-6736(23)00727-4. Epub 2023 Apr 16.</citation>
      <PMID>37075781</PMID>
    </reference>
    <reference>
      <citation>Oh DY, Lee KH, Lee DW, Yoon J, Kim TY, Bang JH, Nam AR, Oh KS, Kim JM, Lee Y, Guthrie V, McCoon P, Li W, Wu S, Zhang Q, Rebelatto MC, Kim JW. Gemcitabine and cisplatin plus durvalumab with or without tremelimumab in chemotherapy-naive patients with advanced biliary tract cancer: an open-label, single-centre, phase 2 study. Lancet Gastroenterol Hepatol. 2022 Jun;7(6):522-532. doi: 10.1016/S2468-1253(22)00043-7. Epub 2022 Mar 9. Erratum In: Lancet Gastroenterol Hepatol. 2023 Jun;8(6):e5.</citation>
      <PMID>35278356</PMID>
    </reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 21, 2023</study_first_submitted>
    <study_first_submitted_qc>August 12, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 16, 2023</study_first_posted>
    <last_update_submitted>August 12, 2023</last_update_submitted>
    <last_update_submitted_qc>August 12, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 16, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Biliary Tract Neoplasms</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Antibodies, Bispecific</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05994001
  org study id: ZSAB-Calm
  nct id: NCT05994001
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  In this clinical study, we will evaluate the efficacy and safety of cardonilimumab (PD1
        monoclonal antibody and CTLA-4 monoclonal antibody bisspecific antibodies) and LM-302
        (Claudin18.2-ADC) in Claudin18.2-positive advanced BTC patients who have progressed after SOC
        and PD1/PD-L1 monoclonal antibody treatment.
  The prognosis for unresectable and metastatic biliary malignancies (BTC) is extremely poor,
        with a median overall survival of only about 1 year for advanced biliary tumors treated with
        gemcitabine and cisplatin or combined with duvaliumab (PD-L1) as recommended by NCCN
        guidelines. At present, the NCCN guidelines recommend that the posterior line treatment of
        advanced BTC, such as FOLFOX, has a very limited effect, with an objective response rate of
        only about 5% and a median survival time of only about 6 months. There is an urgent need to
        develop new therapeutic methods to improve patient survival. Chronic inflammation caused by
        viral infection and bile duct stones are the most common potential risk factors for BTC, and
        immune system abnormalities play a key role in the occurrence and development of BTC. BTC,
        including intrahepatic cholangiocarcinoma (iCCA), showed abnormal expression of immune
        checkpoint molecules PD-L1 and CTLA-4 and obvious heterogeneity. Therefore, immunotherapy is
        of great value. TOPAZ-1 and KENOTE-966 studies both showed the value of PD-L1/PD1 monoclonal
        antibody in the treatment of advanced BTC. There is currently a lack of treatment options for
        progression after treatment with standard chemotherapy (SOC) combined with PD-L1/PD1
        monoclonal antibodies. CTLA-4 inhibitors combined with PD-1/PD-L1 inhibitors have shown
        significantly enhanced clinical effects. Clinical studies on treating CTLA-4 inhibitors
        combined with PD-1/PD-L1 inhibitors have been carried out in several solid tumors. Although
        significant therapeutic effects have been achieved, adverse reactions (AEs) that cannot be
        ignored limit the benefit of patients. Claudin18.2 is a newly discovered tumor therapeutic
        target. Multiple clinical studies have shown that Claudin18.2 monoclonal antibody,
        Claudin18.2-ADC, and Cart-Claudin18.2 have good ORR in Claudin18.2-positive gastric cancer.
        At present, no independent research data on advanced BTC has been reported.
  
        In this clinical study, we will evaluate the efficacy and safety of cardonilimumab (PD1
        monoclonal antibody and CTLA-4 monoclonal antibody bispecific antibodies) and LM-302
        (Claudin18.2-ADC) in Claudin18.2-positive advanced BTC patients who have progressed after SOC
        and PD1/PD-L1 monoclonal antibody treatment.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Each cycle of the first phase was defined as cardonilizumab (6mg/kg,Q2W) combined with different concentrations of 1.6mg/kg or 1.8mg/kg LM-302 (Q2W), 14 days as a course of treatment, and the combined dose (RP2D) of LM-302 during combination therapy was determined according to the 3+3 design.
  In the second phase, Claudin18.2 expression was positive, and the positive population was randomly assigned to trial group 1, trial group 2, and trial group 3.
  Group 1:6 mg/kg cardonilizumab, 14 days for 1 course. Group 2:1.8mg /mg LM-302 was treated for 1 course for 14 days. Group 3: 6 mg/kg cardonilizumab for 14 days was a course of treatment; RP2D LM-302 is 1 course of treatment for 14 days.
  primary purpose: Treatment
  masking: Single (Participant)
  masking description: Each cycle of the first phase was defined as cardonilizumab (6mg/kg,Q2W) combined with different concentrations of 1.6mg/kg or 1.8mg/kg LM-302 (Q2W), 14 days as a course of treatment, and the combined dose (RP2D) of LM-302 during combination therapy was determined according to the 3+3 design.
  In the second phase, Claudin18.2 expression was positive, and the positive population was randomly assigned to trial group 1, trial group 2, and trial group 3.
  Group 1:6 mg/kg cardonilizumab, 14 days for 1 course. Group 2:1.8mg /mg LM-302 was treated for 1 course for 14 days. Group 3: 6 mg/kg cardonilizumab for 14 days was a course of treatment; RP2D LM-302 is 1 course of treatment for 14 days.
  measure: ORR(Phase II)
  time frame: 24months
  description: Objective response rate (ORR) in patients with Claudin18.2-positive treated with cardonillizumab combined with LM302 (RECIST 1.1)(Phase II)
  measure: Incidence of Treatment-Emergent Adverse Events(Phase I)
  time frame: 24months
  description: Safety of cardonilizumab in combination with different doses of LM-302 in patients with advanced BTC
  measure: DOR
  time frame: 24months
  description: duration of overall response
  measure: DCR
  time frame: 24months
  description: disease control rate
  measure: OS
  time frame: 24months
  description: Overall survival
  arm group label: Group 1
  arm group type: Experimental
  description: 6 mg/kg cardonilizumab, 14 days for 1 course.
  arm group label: Group 2
  arm group type: Experimental
  description: 1.8mg /mg LM-302 was treated for 1 course for 14 days.
  arm group label: Group 3
  arm group type: Experimental
  description: 6 mg/kg cardonilizumab for 14 days was a course of treatment; RP2D LM-302 is 1 course of treatment for 14 days
  intervention type: Drug
  intervention name: cardonilizumab
  description: cardonilizumab:PD1 and CTLA-4 bispecific antibody
  arm group label: Group 1
  arm group label: Group 3
  other name: PD1 and CTLA-4 bispecific antibody
  intervention type: Drug
  intervention name: LM-302
  description: LM-302 :ClAUDIN 18.2-ADC
  arm group label: Group 2
  arm group label: Group 3
  other name: ClAUDIN 18.2-ADC
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Jia Fan, MD
  role: Principal Investigator
  affiliation: Fudan University
  last name: Guo-Ming Shi, MD
  phone: +86-13916969578
  email: shi.guoming@zs-hospital.sh.cn
  last name: Xiao-Yong Huang, MD
  phone: +86-15021519215
  email: huang.xiaoyong@zs-hospital.sh.cn
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: China
  citation: Kelley RK, Ueno M, Yoo C, Finn RS, Furuse J, Ren Z, Yau T, Klumpen HJ, Chan SL, Ozaka M, Verslype C, Bouattour M, Park JO, Barajas O, Pelzer U, Valle JW, Yu L, Malhotra U, Siegel AB, Edeline J, Vogel A; KEYNOTE-966 Investigators. Pembrolizumab in combination with gemcitabine and cisplatin compared with gemcitabine and cisplatin alone for patients with advanced biliary tract cancer (KEYNOTE-966): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2023 Jun 3;401(10391):1853-1865. doi: 10.1016/S0140-6736(23)00727-4. Epub 2023 Apr 16.
  PMID: 37075781
  citation: Oh DY, Lee KH, Lee DW, Yoon J, Kim TY, Bang JH, Nam AR, Oh KS, Kim JM, Lee Y, Guthrie V, McCoon P, Li W, Wu S, Zhang Q, Rebelatto MC, Kim JW. Gemcitabine and cisplatin plus durvalumab with or without tremelimumab in chemotherapy-naive patients with advanced biliary tract cancer: an open-label, single-centre, phase 2 study. Lancet Gastroenterol Hepatol. 2022 Jun;7(6):522-532. doi: 10.1016/S2468-1253(22)00043-7. Epub 2022 Mar 9. Erratum In: Lancet Gastroenterol Hepatol. 2023 Jun;8(6):e5.
  PMID: 35278356
  responsible party type: Sponsor
  mesh term: Biliary Tract Neoplasms
  mesh term: Antibodies, Bispecific
  sharing ipd: No