[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07444541":3,"trial-entities:NCT07444541":92,"trial-summary:NCT07444541":96},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":15,"conditions":17,"keywords":19,"study_type":20,"primary_purpose":21,"phases":22,"enrollment_info":25,"interventions":28,"primary_outcomes":48,"secondary_outcomes":57,"sex":58,"minimum_age":59,"maximum_age":15,"healthy_volunteers":60,"eligibility_criteria":61,"std_ages":65,"locations":68,"central_contacts":84,"overall_officials":89,"references":90,"see_also_links":91},"NCT07444541","ANO31905-204","ANO31905 in Combination With Chemotherapy for CLDN18.2-Positive Locally Advanced Unresectable or Metastatic Pancreatic Cancer","A Phase Ib\u002FⅡ Clinical Study to Evaluate the Safety and Efficacy of ANO31905 for Injection in Combination With Chemotherapy as the First-line Treatment for Patients With CLDN18.2-Positive Locally Advanced Unresectable or Metastatic Pancreatic Cancer","RECRUITING","2028-12","2026-04","2026-07-27","2026-08","Anova Innovation Limited","INDUSTRY",null,"The goal of this clinical trial is to assess the safety and efficacy of ANO31905 in combination with chemotherapy as the first-line treatment for subjects with CLDN18.2-positive locally advanced unresectable or metastatic pancreatic cancer.",[18],"Pancreatic Cancer",[],"INTERVENTIONAL","TREATMENT",[23,24],"PHASE1","PHASE2",{"count":26,"type":27},84,"ESTIMATED",[29,35,39,44],{"type":30,"name":31,"description":32,"armGroupLabels":33},"BIOLOGICAL","ANO31905","The initial dose is 500 μg\u002Fkg Q2W. The drug will be administered on D1\u002FD15 of each cycle. The maximum duration of administration is tentatively set at 2 years.",[34],"ANO31905 (low dose) plus GEM+Nab-P",{"type":30,"name":31,"description":36,"armGroupLabels":37},"ANO31905: If the lower dose is tolerated, a higher dose of 800 μg\u002Fkg will be administered to the subjects. ANO31905 will be administered on D1\u002FD15 of each cycle. The maximum duration of administration is tentatively set at 2 years.",[38],"ANO31905 (high dose) plus GEM+Nab-P",{"type":40,"name":41,"description":42,"armGroupLabels":43},"DRUG","Nanoparticle Albumin-Bound Paclitaxel","125 mg\u002Fm\\^2, intravenous infusion, D1\u002FD8\u002FD15 per cycle until PD, intolerable toxicity, or other discontinuation criteria specified in the protocol (whichever occurs first).",[38,34],{"type":40,"name":45,"description":46,"armGroupLabels":47},"Gemcitabine","1000 mg\u002Fm\\^2, intravenous infusion, D1\u002FD8\u002FD15 per cycle until PD, intolerable toxicity, or other discontinuation criteria specified in the protocol (whichever occurs first).",[38,34],[49,53],{"measure":50,"description":51,"timeFrame":52},"Dose-limiting toxicity (DLT) (Phase Ib).","The severity of adverse events (AEs) will be graded according to the Common Terminology Criteria for Adverse Events Version 6.0. AEs that occur during the DLT observation period and are judged to be \"definitely related\", \"probably related\", or \"possibly related\" to any investigational products will be deemed as a DLT event.","At the end of Cycle 1 (each cycle is 28 days)",{"measure":54,"description":55,"timeFrame":56},"Objective response rate (ORR) assessed by the investigator according to Response Evaluation Criteria for Solid Tumors Version 1.1 (RECIST v1.1) (Phase Ⅱ)","Objective response rate (ORR) is defined as the proportion of patients with the best efficacy evaluation of complete response (CR) or partial response (PR) during the study. From date of treatment start until disease progression, date of death or withdrawal from study, whichever came first.","Up to 12 months",[],"ALL","18 Years",false,{"inclusion":62,"exclusion":63,"raw_text":64},[],[],"Inclusion Criteria:\n\n1. Males or females aged ≥ 18 at the time of signing the ICF;\n2. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;\n3. Expected survival ≥ 3 months;\n4. Histologically or cytologically confirmed diagnosis of pancreatic ductal adenocarcinoma;\n5. At least one measurable lesion according to RECIST v1.1;\n6. Tumor tissue samples are determined to be CLDN18.2-positive by immunohistochemistry (IHC) in the central laboratory;\n7. Patients with sufficient organ function within 7 days before the first study dose;\n8. Non-pregnant or -lactating women.\n\nExclusion Criteria:\n\n1. Patients with other malignant tumors except pancreatic adenocarcinoma within 5 years before the first dose of the study treatment; Any previous systematic anti-cancer therapy\n2. Any previous systematic anti-cancer therapy;\n3. Previous treatment targeting CLDN18.2;\n4. Patients with a history of active autoimmune disorders or autoimmune disorders requiring systemic treatment;\n5. Patients with known hypersensitivity to any component or excipient of ANO31905, gemcitabine, and nanoparticle albumin-bound paclitaxel;\n6. Patients with known metastases to the central nervous system;\n7. Patients with severe cardiovascular and cardiovascular diseases;\n8. Presence risks of thrombosis or bleeding;\n9. Patients who have received attenuated live vaccines within 28 days before the first study dose or are expected to receive attenuated live vaccines during study treatment;\n10. Patients with gastrointestinal diseases that are not suitable for enrollment as judged by the investigator;\n11. Patients with other conditions that may place the patients at increased undue study-related risks.",[66,67],"ADULT","OLDER_ADULT",[69],{"facility":70,"status":8,"city":71,"state":72,"zip":73,"country":74,"contacts":75,"geoPoint":81},"California Research Institute","Los Angeles","California","90027","United States",[76],{"name":77,"role":78,"phone":79,"email":80},"Ghassan Al-Jazayrly","CONTACT","323-660-6200","pi@caresinst.com",{"lat":82,"lon":83},34.05223,-118.24368,[85],{"name":86,"role":78,"phone":87,"email":88},"Lei Zheng Mays Cancer Center","210-450-5798","zhengl@uthscsa.edu",[],[],[],{"nct_id":4,"conditions":93,"biomarkers":95},[94],"Pancreatic Ductal Adenocarcinoma",[],{"nct_id":4,"found":97,"summary":98,"prompt_version":108},true,{"design":99,"status":100,"heading":101,"summary":102,"follow_up":103,"word_count":104,"commitments":105,"compensation":106,"drugs_mentioned":107},"This is an interventional study with a planned enrollment of 84 participants. The phase of the study is not specified.","completed","ANO31905 with Chemotherapy for CLDN18.2-Positive Pancreatic Cancer","This study is testing a new treatment called ANO31905 combined with standard chemotherapy (Nanoparticle Albumin-Bound Paclitaxel and Gemcitabine) for people with pancreatic cancer that has spread or cannot be removed by surgery. This specific type of pancreatic cancer is called CLDN18.2-positive. Researchers want to see how safe and effective this combination treatment is. To join, you must be at least 18 years old, have a good general health status, and your cancer must be CLDN18.2-positive. The study aims to find the best dose of ANO31905 and measure how many participants respond to the treatment. The current recruitment status is unclear.","The study will measure how well participants respond to treatment for up to 12 months.",100,"Participants will receive ANO31905 and chemotherapy on specific days of each cycle, potentially for up to 2 years.","Not stated in the trial record.",[31,41,45],"v2"]