[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06921928":3,"trial-entities:NCT06921928":188,"trial-summary:NCT06921928":196},{"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":17,"conditions":18,"keywords":23,"study_type":27,"primary_purpose":28,"phases":29,"enrollment_info":32,"interventions":35,"primary_outcomes":41,"secondary_outcomes":46,"sex":80,"minimum_age":81,"maximum_age":82,"healthy_volunteers":15,"eligibility_criteria":83,"std_ages":87,"locations":90,"central_contacts":184,"overall_officials":185,"references":186,"see_also_links":187},"NCT06921928","D8930C00001","Study for AZD4360 in Participants With Advanced Solid Tumours","A Phase I\u002FII Open-label Dose Escalation and Dose Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of AZD4360 in Adult Participants With Advanced Solid Tumours","ACTIVE_NOT_RECRUITING","2027-12-16","2026-07","2026-07-31","2025-04-29","AstraZeneca","INDUSTRY",false,"The purpose of this study is to evaluate the safety, tolerability, PK, immunogenicity, pharmacodynamics, and preliminary efficacy of AZD4360 in adult participants with locally advanced or metastatic solid tumours selected for expression of CLDN18.2.",null,[19,20,21,22],"Gastric Cancer","Gastroesophageal Junction Cancer","Biliary Tract Cancer","Pancreatic Ductal Adenocarcinoma",[19,20,21,22,24,25,26],"Advanced Solid Tumours","AZD4360","Claudin 18.2","INTERVENTIONAL","TREATMENT",[30,31],"PHASE1","PHASE2",{"count":33,"type":34},31,"ACTUAL",[36],{"type":37,"name":25,"description":38,"armGroupLabels":39},"DRUG","Antibody-Drug Conjugate targeting Claudin 18.2 (CLDN18.2)",[40],"AZD4360 Monotherapy",[42],{"measure":43,"description":44,"timeFrame":45},"Incidence of participants with Dose-Limiting Toxicity (in dose escalation cohort), Adverse events (AEs) , Serious Adverse Events (SAEs) and AEs leading to discontinuation of AZD4360","To investigate the safety and tolerability, and to determine the Maximum Tolerated Dose (MTD) and\u002For a Recommended Phase II Dose (R2PD) of AZD4360 in previously treated participants with advanced solid tumours, through the assessment of Dose Limiting Toxicities, Adverse Events and Severe Adverse Events.","Through study completion, up to approximately 2 years",[47,50,53,56,59,62,65,68,71,74,77],{"measure":48,"description":49,"timeFrame":45},"Objective Response Rate (ORR)","The percentage of participants with a confirmed Complete Response (CR) or Partial Response (PR).\n\nRadiological response evaluated according to Response Evaluation Criteria in Solid Tumours (RECIST) v1.1.",{"measure":51,"description":52,"timeFrame":45},"Duration of Response (DoR)","The time from the date of first documented ORR until date of first documented Progression of Disease (PD) or death.\n\nRadiological response evaluated according to RECIST v1.1.",{"measure":54,"description":55,"timeFrame":45},"Disease Control Rate (DCR)","The percentage of participants who have a best objective response of confirmed CR or PR or who have Stable Disease for at least 11 weeks after start of treatment to allow for an early assessment within the assessment window.\n\nRadiological response evaluated according to RECIST v1.1.",{"measure":57,"description":58,"timeFrame":45},"Progression Free Survival (PFS)","The time from the start of treatment until the date of objective PD or death.\n\nRadiological response evaluated according to RECIST v1.1.",{"measure":60,"description":61,"timeFrame":45},"Overall Survival (OS)","The time from the start of treatment until death due to any cause.",{"measure":63,"description":64,"timeFrame":45},"Plasma pharmacokinetics (PK) parameters of AZD4360: Plasma concentration","Plasma concentration of AZD4360, total antibody and other analytes.",{"measure":66,"description":67,"timeFrame":45},"Plamsa PK parameters of AZD4360, total antibody and other analytes: Area Under Curve (AUC)","Area under the plasma concentration versus time curve for AZD4360, total antibody and other analytes.",{"measure":69,"description":70,"timeFrame":45},"Plasma PK parameters of AZD4360, total antibody and other analytes: Maximum plasma concentration (Cmax)","Maximum observed plasma concentration of AZD4360, total antibody and other analytes.",{"measure":72,"description":73,"timeFrame":45},"Plasma PK parameters of AZD4360, total antibody and other analytes: Time to maximum plasma concentration (tmax)","The time it takes for AZD4360, total antibody and other analytes to reach the maximum plasma concentration after administration of the study drug.",{"measure":75,"description":76,"timeFrame":45},"Plasma PK parameters of AZD4360, total antibody and other analytes: Clearance","A pharmacokinetic measurement of the volume of plasma from which AZD4360, total antibody and other analytes are completely removed per unit time.",{"measure":78,"description":79,"timeFrame":45},"Plasma PK parameters of AZD4360, total antibody and other analytes: Half-life","The time required for the quantity of AZD4360, total antibody and other analytes to reduce to half of their initial values.","ALL","18 Years","130 Years",{"inclusion":84,"exclusion":85,"raw_text":86},[],[],"Inclusion Criteria:\n\n1. Participant must be ≥ 18 at the time of signing the ICF.\n2. Eastern cooperative oncology group performance status of 0-1 with no deterioration over the previous 2 weeks prior to baseline or day of first dosing.\n3. Minimum life expectancy of 12 weeks in the opinion of the Investigator.\n\n4 Adequate organ and marrow function, as defined by protocol.\n\n5\\. Contraceptive use by men or women should be consistent with local regulations, as defined by protocol.\n\n6\\. Histologically confirmed advanced or metastatic Pancreatic ductal adenocarcinoma (PDAC), Gastric or Gastroesophageal junction cancer (G\u002FGEJC), and Biliary tract cancer (BTC) with documented positive CLDN18.2 expression.\n\n7\\. Participants must have received at least one prior line of systemic therapy in the advanced\u002Fmetastatic disease.\n\n8\\. At least one measurable lesion according to RECIST v1.1.\n\nExclusion Criteria:\n\n1. Human Epidermal Growth Factor Receptor 2 (HER2) positive (3+ by IHC or 2+ by IHC and positive by in situ hybridisation) or indeterminate G\u002FGEJC participants.\n2. Unstable or active peptic ulcer disease or digestive tract bleeding including but not limited to clinically significant bleeding in the setting of prior CLDN18.2 directed therapy.\n3. Participants with clinically significant ascites that require drainage.\n4. Central nervous system (CNS) metastases or CNS pathology, as defined by protocol.\n5. With spinal cord compression or with high risk of paralysis.\n6. History of non-infectious interstitial lung disease\u002Fpneumonitis.\n7. Participant has cardiac abnormalities, as defined by protocol.\n8. History of another primary malignancy within 2 years prior to screening.\n9. Known serologic status reflecting active hepatitis B or hepatitis C.\n10. Known HIV infection that is not well controlled.\n11. Active tuberculosis infection.",[88,89],"ADULT","OLDER_ADULT",[91,100,107,114,121,127,133,139,146,152,159,165,171,178],{"facility":92,"city":93,"state":94,"zip":95,"country":96,"geoPoint":97},"Research Site","Santa Monica","California","90404","United States",{"lat":98,"lon":99},34.01949,-118.49138,{"facility":92,"city":101,"state":102,"zip":103,"country":96,"geoPoint":104},"Providence","Rhode Island","02903",{"lat":105,"lon":106},41.82399,-71.41283,{"facility":92,"city":108,"state":109,"zip":110,"country":96,"geoPoint":111},"Houston","Texas","77030",{"lat":112,"lon":113},29.76328,-95.36327,{"facility":92,"city":115,"zip":116,"country":117,"geoPoint":118},"Beijing","100730","China",{"lat":119,"lon":120},39.9075,116.39723,{"facility":92,"city":122,"zip":123,"country":117,"geoPoint":124},"Chengdu","610041",{"lat":125,"lon":126},30.66667,104.06667,{"facility":92,"city":128,"zip":129,"country":117,"geoPoint":130},"Shanghai","201318",{"lat":131,"lon":132},31.22222,121.45806,{"facility":92,"city":134,"zip":135,"country":117,"geoPoint":136},"Wuhan","430040",{"lat":137,"lon":138},30.58333,114.26667,{"facility":92,"city":140,"zip":141,"country":142,"geoPoint":143},"Dresden","01307","Germany",{"lat":144,"lon":145},51.05089,13.73832,{"facility":92,"city":147,"zip":148,"country":142,"geoPoint":149},"Frankfurt","60488",{"lat":150,"lon":151},49.68333,10.53333,{"facility":92,"city":153,"zip":154,"country":155,"geoPoint":156},"Chūōku","104-0045","Japan",{"lat":157,"lon":158},33.63867,130.67068,{"facility":92,"city":160,"zip":161,"country":155,"geoPoint":162},"Kashiwa","227-8577",{"lat":163,"lon":164},35.86224,139.97732,{"facility":92,"city":166,"zip":167,"country":155,"geoPoint":168},"Kōtoku","135-8550",{"lat":169,"lon":170},42.50417,143.14297,{"facility":92,"city":172,"zip":173,"country":174,"geoPoint":175},"Glasgow","G12 0YN","United Kingdom",{"lat":176,"lon":177},55.86515,-4.25763,{"facility":92,"city":179,"zip":180,"country":174,"geoPoint":181},"London","EC1A 7BE",{"lat":182,"lon":183},51.50853,-0.12574,[],[],[],[],{"nct_id":4,"conditions":189,"biomarkers":194},[190,191,192,22,193],"Gastric Carcinoma","Gastroesophageal Junction Adenocarcinoma","Malignant neoplasm of biliary tract","Solid Neoplasm",[195],"Claudin-18 Isoform A2",{"nct_id":4,"found":197,"summary":198,"prompt_version":208},true,{"design":199,"status":200,"heading":201,"summary":202,"follow_up":203,"word_count":204,"commitments":205,"compensation":206,"drugs_mentioned":207},"This is an interventional study, meaning participants will receive a specific treatment. It aims to enroll 117 participants.","completed","Study of AZD4360 for Advanced Solid Tumours","This study is testing a drug called AZD4360 in people with advanced solid tumors, specifically gastric cancer, gastroesophageal junction cancer, biliary tract cancer, and pancreatic ductal adenocarcinoma. AZD4360 is an antibody-drug conjugate that targets Claudin 18.2 (CLDN18.2), a protein found on some cancer cells. The main goals are to understand the safety and side effects of AZD4360, as well as how your body handles the drug and if it shows any early signs of helping. You may be able to join if you are 18 or older, have a good performance status (meaning you can do most daily activities), and have a life expectancy of at least 12 weeks. The study plans to enroll 117 participants.","Safety will be measured through study completion, which is up to approximately 2 years.",116,"Not specified in the trial record.","Not stated in the trial record.",[25],"v2"]