[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100652165":3},{"organization":4,"armGroups":7,"interventions":29,"overallOfficials":42,"centralContacts":46,"locations":52,"responsibleParty":100,"collaborators":35,"id":102,"slug":103,"hasResults":104,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":35,"eligibilityCriteria":108,"healthyVolunteers":104,"sex":109,"minAge":110,"maxAge":35,"enrollmentInfo":111,"targetDuration":35,"studyType":114,"phases":115,"briefSummary":117,"conditions":118,"keywords":121,"overallStatus":124,"whyStopped":35,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":134},{"fullName":5,"class":6},"AbbVie","INDUSTRY",[8,15,19,23],{"label":9,"type":10,"description":11,"interventionNames":12},"SS1: Dose Escalation: Telisotuzumab Adizutecan + Gemcitabine","EXPERIMENTAL","Participants will receive Telisotuzumab Adizutecan + Gemcitabine until doses for optimization are determined. as part of an approximately 3 year study period.",[13,14],"Drug: Telisotuzumab Adizutecan","Drug: Gemcitabine",{"label":16,"type":10,"description":17,"interventionNames":18},"SS1:DoseOptimization:TelisotuzumabAdizutecan+Gemcitabine DoseA","Participants will receive Telisotuzumab Adizutecan Dose A + Gemcitabine as part of the approximately 3 year study duration.",[13,14],{"label":20,"type":10,"description":21,"interventionNames":22},"SS1:DoseOptimization:TelisotuzumabAdizutecan+GemcitabineDoseB","Participants will receive Telisotuzumab Adizutecan Dose B + Gemcitabine as part of the approximately 3 year study duration.",[13,14],{"label":24,"type":25,"description":26,"interventionNames":27},"SS1: Dose Optimization: Standard of Care (SOC)","ACTIVE_COMPARATOR","Participants will receive gemcitabine and nab-paclitaxel as part of the approximately 3 year study duration.",[14,28],"Drug: Nab-Paclitaxel",[30,36,39],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"DRUG","Telisotuzumab Adizutecan","Intravenous (IV) Infusion",[9,16,20],null,{"type":31,"name":37,"description":33,"armGroupLabels":38,"otherNames":35},"Gemcitabine",[9,24,16,20],{"type":31,"name":40,"description":33,"armGroupLabels":41,"otherNames":35},"Nab-Paclitaxel",[24],[43],{"name":44,"affiliation":5,"role":45},"ABBVIE INC.","STUDY_DIRECTOR",[47],{"name":48,"role":49,"phone":50,"phoneExt":35,"email":51},"ABBVIE CALL CENTER","CONTACT","844-663-3742","abbvieclinicaltrials@abbvie.com",[53,66,78,90],{"facility":54,"status":35,"city":55,"state":56,"zip":57,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":35},"Roswell Park Cancer Institute \u002FID# 284461","Buffalo","New York","14263","United States","US",{"type":61,"coordinates":62},"Point",[63,64],-78.87837,42.88645,{"lat":64,"lon":63},{"facility":67,"status":35,"city":68,"state":69,"zip":70,"country":71,"countryCode":72,"cosmosGeoPoint":73,"geoPoint":77,"contacts":35},"McGill University Health Centre - Glen Site \u002FID# 285570","Montreal","Quebec","H4A 3J1","Canada","CA",{"type":61,"coordinates":74},[75,76],-73.58781,45.50884,{"lat":76,"lon":75},{"facility":79,"status":35,"city":80,"state":81,"zip":82,"country":83,"countryCode":84,"cosmosGeoPoint":85,"geoPoint":89,"contacts":35},"Cancer Hospital - Chinese Academy of Medical Sciences \u002FID# 281737","Beijing","Beijing Municipality","100021","China","CN",{"type":61,"coordinates":86},[87,88],116.39723,39.9075,{"lat":88,"lon":87},{"facility":91,"status":35,"city":92,"state":93,"zip":94,"country":83,"countryCode":84,"cosmosGeoPoint":95,"geoPoint":99,"contacts":35},"West China Hospital of Sichuan University \u002FID# 281734","Chengdu","Sichuan","610041",{"type":61,"coordinates":96},[97,98],104.06667,30.66667,{"lat":98,"lon":97},{"type":101,"investigatorFullName":35,"investigatorTitle":35,"investigatorAffiliation":35,"oldNameTitle":35,"oldOrganization":35},"SPONSOR","100652165","phase-2-a-study-to-assess-adverse-events-and-change-in-disease-activity-with-treatment-combinations-with-telisotuzumab-adizutecan-in-adults-participants-with-pancreatobiliary-cancers-100652165",false,"NCT07769502","A Study to Assess Adverse Events and Change in Disease Activity With Treatment Combinations With Telisotuzumab Adizutecan in Adults Participants With Pancreatobiliary Cancers","A Phase 2, Open-Label, Master Protocol Study to Evaluate Safety and Efficacy of Treatment Combinations With Telisotuzumab Adizutecan in Subjects With Pancreatobiliary Cancers (AndroMETa-118)","Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) Performance status (PS) of 0 or 1.\n* Resolution of any acute clinically significant treatment-related toxicity from prior therapy to Grade \\\u003C= 1 prior to study entry (except for alopecia of any grade).\n* Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 at baseline. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.\n\nExclusion Criteria:\n\n* Prior cellular-Mesenchymal Epithelial Transition (c-MET) protein targeting therapy\n* History of interstitial lung disease (ILD) or pneumonitis that required treatment with systemic steroids, or any evidence of active ILD\u002Fpneumonitis on screening chest computed tomography (CT) scan, including a history of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug induced pneumonitis, or idiopathic pneumonitis.\n* Has had major surgery or significant traumatic injury within 28 days prior to randomization\u002Fenrollment, or anticipation of the need for major surgery during the course of study intervention. Placement of biliary stent\u002Ftube is permitted.","ALL","18 Years",{"count":112,"type":113},168,"ESTIMATED","INTERVENTIONAL",[116],"PHASE2","Cancer is a condition where cells in a specific part of the body grow and reproduce uncontrollably. The pancreas is a gland behind the stomach that produces a digestive fluid that is emptied into the intestines through tube shaped ducts. Pancreatic cancer often starts in these ducts. The goal of this study is to evaluate the safety and efficacy of telisotuzumab adizutecan in combination with gemcitabine and nab-paclitaxel in adult participants with pancreatobiliary cancers.\n\nTelisotuzumab adizutecan is an investigational drug being developed for the treatment of pancreatobiliary cancers. In Substudy 1, participants will be randomized into two groups. One group will receive different doses of telisotuzumab adizutecan with gemcitabine. The other group will receive standard of care (SOC) - gemcitabine and nab-paclitaxel. Approximately 168 participants will be enrolled in this study in approximately 50 sites worldwide.\n\nSubstudy 1 includes a dose escalation stage and a dose optimization stage. In the dose escalation stage, participants will receive escalating doses of Intravenous (IV) telisotuzumab adizutecan + Gemcitabine. In the dose optimization stage, participants will receive 1 of 2 doses of IV telisotuzumab adizutecan with Gemcitabine or SOC. The study will run for a duration of approximately 3 years.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.",[119,120],"Pancreatobiliary Cancers","Pancreatic Ductal Adenocarcinoma",[119,120,122,32,123],"PDAC","Cancer","NOT_YET_RECRUITING","2026-08-13",{"date":127,"type":128},"2026-08-18","ACTUAL",{"date":130,"type":113},"2026-09-22",{"date":132,"type":113},"2028-11",{"name":5,"class":6},4]