[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100532986":3},{"organization":4,"outcomesModule":7,"designInfo":52,"detailedDescription":59,"studyPopulation":51,"armGroups":60,"interventions":81,"overallOfficials":51,"centralContacts":120,"locations":126,"responsibleParty":549,"collaborators":51,"id":551,"slug":552,"hasResults":553,"nctId":554,"briefTitle":555,"officialTitle":556,"acronym":51,"eligibilityCriteria":557,"healthyVolunteers":553,"sex":558,"minAge":559,"maxAge":51,"enrollmentInfo":560,"targetDuration":51,"studyType":563,"phases":564,"briefSummary":566,"conditions":567,"keywords":572,"overallStatus":129,"whyStopped":51,"lastUpdateSubmitDate":578,"lastUpdatePostDateStruct":579,"startDateStruct":582,"completionDateStruct":584,"leadSponsor":586,"locationsCount":587},{"fullName":5,"class":6},"AstraZeneca","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":51},[9,13],{"measure":10,"description":11,"timeFrame":12},"Incidence of adverse events (AEs), serious AEs (SAEs). Changes from baseline in clinical laboratory parameters, vital signs, ECGs and physical examination. Rate of AEs leading to discontinuation of AZD0901, Occurrence of DLTs.","To investigate the safety and tolerability, of AZD0901 monotherapy or in combination with anti-cancer agents in particpants with advanced or metastatic solid tumours expressing CLDN18.2.","30 days post treatment completion. AE Follow Up for 90 days post AZD0901 discontinuation.",{"measure":14,"description":15,"timeFrame":16},"Objective Response Rate (ORR).","Proportion of participants with a confirmed Complete Response (CR) or Partial Response (PR) as determined by the Investigator at local site as per RECIST v1.1.","From date of first dose of AZD0901 up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years).",[18,22,26,30,34,38,42,44,48],{"measure":19,"description":20,"timeFrame":21},"Overall Survival (OS)","The analysis will include all dosed\u002Frandomised participants as assigned\u002Frandomised. All deaths will be included, regardless of whether the participant withdraws from therapy or receives another anticancer therapy.","From date of first dose\u002Frandomisation until the date of death due to any cause (approximately 2 years).",{"measure":23,"description":24,"timeFrame":25},"Progression Free Survival (PFS)","Progression-free survival is defined as the time date of randomisation or enrollment until progression per RECIST v1.1 as assessed by the Investigator at local site, or death due to any cause, regardless of whether the participant withdraws from randomized therapy, receives another anti-cancer therapy or clinically progresses prior to RECIST v1.1 progression.","From date of first dose\u002Frandomisation until disease progression or death in the absence of progression (approximately 2 years).",{"measure":27,"description":28,"timeFrame":29},"Duration of Response (DoR)","The time from the date of first documented confirmed response until date of first documented progression per RECIST v1.1 or death due to any cause.","From the date of first documented confirmed response until date of documented progression (approximately 2 years).",{"measure":31,"description":32,"timeFrame":33},"Disease control rate (DCR)","The percentage of participants who have a confirmed CR or PR or who have SD per RECIST v1.1 as assessed by the Investigator at local site and derived from the raw tumour data up to 11 weeks after date of first dose\u002Frandomisation.","Up to 11 weeks post date of first dose\u002Frandomisation",{"measure":35,"description":36,"timeFrame":37},"Percentage change in tumor size","The best percentage change from baseline in tumor size is the largest decrease (or smallest increase) from baseline for a participant, using RECIST v1.1 assessments.","From start through to study completion.",{"measure":39,"description":40,"timeFrame":41},"Serum concentration of AZD0901 (total ADC), total antibody (conjugated and unconjugated) and total unconjugated MMAE","To characterise the PK of AZD0901 monotherapy or in combination with anti cancer agents in participants with advanced or metastatic solid tumours expressing CLDN18.2.","From date of first dose of AZD0901 up until 90 days post AZD0901 discontinuation.",{"measure":43,"description":40,"timeFrame":41},"Serum PK parameters of AZD0901, total antibody (conjugated and unconjugated) and MMAE including but not limited to AUC, Cmax, tmax, clearance and half-life, as data allow.",{"measure":45,"description":46,"timeFrame":47},"Clinical activity by baseline and\u002For on-treatment tissue-based biomarkers including, but not limited to, gene expression, mutation profiles, DNA damage, protein expression, immune response and\u002For mechanisms of resistance.","To investigate baseline and\u002For on-treatment tissue-based RNA, DNA, and\u002For proteins, and association with clinical activity of AZD0901 (substudy 1).","From date of first dose of AZD0901 up to 7 weeks.",{"measure":49,"description":50,"timeFrame":41},"ADA status will be determined along with prevalence and incidence of anti-drug antibodies to AZD0901, and titer established.","To determine the immunogenicity of AZD0901 monotherapy or in combination with anti-cancer agents in participants with advanced or metastatic solid tumours expressing CLDN18.2.",null,{"allocation":53,"interventionModel":54,"interventionModelDescription":55,"primaryPurpose":56,"observationalModel":51,"timePerspective":51,"maskingInfo":57},"RANDOMIZED","PARALLEL","This study is an open-label, multi-centre study of AZD0901 administered via IV, either as monotherapy or in combination with other anti-cancer agents in participants with advanced solid malignancies expressing CLDN18.2. The substudy design allows for a targeted approach to the different tumour types as monotherapy or in combination with other anti-cancer agents. These substudies include:\n\nSubstudy 1: AZD0901 monotherapy in gastric and gastric esophageal junction cancer patients Substudy 2: AZD0901 in combination with anti-cancer agents in pancreatic cancer patients.\n\nSubstudy 3: AZD0901 monotherapy in biliary Tract Cancer.","TREATMENT",{"masking":58,"maskingDescription":51,"whoMasked":51},"NONE","This open-label, multi-centre study consists of individual sub studies, each evaluating the safety and tolerability of AZD0901.\n\nSub study 1 will investigate the safety, tolerability, and anti-tumour activity of AZD0901 monotherapy in participants with advanced or metastatic gastric esophageal cancer expressing CLDN18.2. Participants will receive AZD0901 monotherapy via intravenous (IV) infusion and will be randomised in to one of 2 arms.\n\nSub study 2 will consist of two parts, a safety run-in and a dose expansion part to investigate the safety and efficacy of AZD0901 in combination with different chemotherapy agents in participants with pancreatic cancer. Substudy 3 will investigate the safety, tolerability, and anti-tumour activity of AZD0901 monotherapy in participants with advanced or metastatic Biliary tract cancer.",[61,67,77],{"label":62,"type":63,"description":64,"interventionNames":65},"Sub Study 1 - AZD0901 MONOTHERAPY","EXPERIMENTAL","Sub Study 1 will investigate AZD0901 monotherapy in order to evaluate the safety, tolerability, and efficacy of AZD0901.",[66],"Drug: AZD0901",{"label":68,"type":63,"description":69,"interventionNames":70},"Sub Study 2 - AZD0901 IN COMBINATION WITH ANTI-CANCER AGENTS IN PANCREATIC DUCTAL ADENOCARCINOMA","Substudy 2 will investigate the safety and efficacy of AZD0901 as first line systemic treatment used in combination with different chemotherapy agents",[66,71,72,73,74,75,76],"Drug: 5-Fluorouracil","Drug: Leucovorin","Drug: l-leucovorin","Drug: Irinotecan","Drug: Nanoliposomal Irinotecan","Drug: Gemcitabine",{"label":78,"type":63,"description":79,"interventionNames":80},"Sub Study 3: AZD0901 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7LE",{"type":136,"coordinates":545},[546,547],-1.25596,51.75222,{"lat":547,"lon":546},{"type":550,"investigatorFullName":51,"investigatorTitle":51,"investigatorAffiliation":51,"oldNameTitle":51,"oldOrganization":51},"SPONSOR","100532986","phase-2-azd0901-in-participants-with-advanced-solid-tumours-expressing-claudin182-100532986",false,"NCT06219941","AZD0901 in Participants With Advanced Solid Tumours Expressing Claudin18.2","A Phase II, Open-label, Multi-centre Study to Evaluate Safety, Tolerability, Efficacy, PK, and Immunogenicity of AZD0901 as Monotherapy and in Combination With Anti-cancer Agents in Participants With Advanced Solid Tumours Expressing Claudin 18.2 (CLARITY-PanTumour01)","The list below is a summarised eligibility criteria for the study - refer to the study protocol for full criteria.\n\nMaster Inclusion Criteria applicable to all sub studies:\n\n* Participant must be ≥ 18 years or the legal age of consent at the time of signing the ICF.\n* Participants who are CLDN18.2 positive.\n* Must have at least one measurable lesion according to RECIST v1.1.\n* ECOG performance status of 0 to 1 with no deterioration over the previous 2 weeks prior first day of dosing.\n* Predicted life expectancy of ≥ 12 weeks.\n* Adequate organ and bone marrow function as defined by protocol.\n* Body weight \\> 35 kg.\n* Participants are willing to comply with contraception requirements.\n\nSub study 1 Specific Inclusion criteria:\n\n* Histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction.\n* Advanced or metastatic GC\u002FGEJC.\n* Maximum 2 prior lines of systemic treatment for unresectable or metastatic disease.\n\nSub study 2 Specific Inclusion criteria:\n\n* Participants diagnosed with histologically confirmed metastatic or advanced PDAC.\n* Availability of an archival sample or a fresh tumour biopsy taken at screening.\n* No prior treatments for unresectable or metastatic disease. Prior neoadjuvant\u002Fadjuvant chemotherapy is permitted as long as participants progressed ≥ 6 months (183 days) from the last dose.\n\nSub study 3 Specific Inclusion criteria\n\n* Histologically confirmed, unresectable advanced, or metastatic adenocarcinoma of biliary tract, including cholangiocarcinoma (intrahepatic or extrahepatic) and gallbladder carcinoma (NOTE: Ampullary cancers are not eligible).\n* Documented radiographic or clinical disease progression on or after at least one prior regimen and maximum 2 prior lines of systemic treatment for unresectable or metastatic disease.\n\nMaster Exclusion Criteria applicable to all sub studies:\n\n* 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.\n* Participants with clinically significant ascites that require drainage.\n* A history of drug-induced non-infectious ILD\u002Fpneumonitis.\n* Central nervous system metastases or CNS pathology.\n* Peripheral neuropathy, sensory, or motor ≥ Grade 2 at screening.\n* History of another primary malignancy.\n* Prior exposure to any MMAE-based ADC.\n* Prior exposure to any CLDN18.2 targeted agents except anti-CLDN18.2 monoclonal antibody.\n\nSub study 1 Specific Exclusion criteria:\n\n* Participants with HER2-positive (3+ by IHC, or 2+ by IHC, and positive by ISH) or indeterminate GC\u002FGEJC unless they have failed\u002Fnot tolerated\u002For are not eligible for standard anti-HER2 therapy, where available.\n* Any factors that increase the risk of QTc prolongation or risk of arrhythmic events.\n* The use of concomitant medications known to prolong the QT\u002FQTc interval.\n\nSub study 2 Specific Exclusion criteria:\n\n* Known DPD enzyme deficiency based on local testing where testing is SoC.\n* Use of strong inhibitor or inducer of UGT1A1.\n* Use of strong inhibitors or inducers of CYP3A4.\n* Known homozygous for the UGT1A1\\*28 allele based on local testing where testing is SoC.\n\nSub study 3 Specific Exclusion criteria\n\n• Clinically significant biliary obstruction that has not resolved before enrollment.","ALL","18 Years",{"count":561,"type":562},226,"ESTIMATED","INTERVENTIONAL",[565],"PHASE2","The purpose of this study is to assess the safety, tolerability, efficacy, pharmacokinetics (PK), and immunogenicity of AZD0901 as monotherapy and in combination with anti-cancer agents in participants with locally advanced unresectable or metastatic solid tumours expressing CLDN18.2.",[568,569,570,571],"Gastric Cancer","Gastroesophageal Junction Cancer","Biliary Tract Cancer","Pancreatic Ductal Adenocarcinoma",[573,574,575,570,576,577,84],"Gastric cancer","Gastroesophageal junction cancer","Pancreatic Ductal adenocarcinoma","Phase II","Claudin 18.2","2026-07-28",{"date":580,"type":581},"2026-07-29","ACTUAL",{"date":583,"type":581},"2023-12-13",{"date":585,"type":562},"2027-06-28",{"name":5,"class":6},52]