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A Study to Assess Intravenous (IV) Telisotuzumab Adizutecan in Combination With Fluorouracil, Folinic Acid, and Oxaliplatin (FOLFOX) Compared to Standard of Care in Adult Participants With First-Line Metastatic Pancreatic Ductal Adenocarcinoma

RecruitingPhase 2, Phase 3Ages 18 Years - anyAllAbbVie
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In plain words

What the trial is, and whether it could suit you

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 purpose of this study is to assess adverse events and change in disease activity of telisotuzumab adizutecan when given in combination with fluorouracil, folinic acid, and oxaliplatin (FOLFOX) to treat adult participants with pancreatic ductal cancer. Telisotuzumab adizutecan is an investigational drug being developed for the treatment of pancreatic ductal adenocarcinoma (PDAC). This study will be divided into two phases, with the first phase (Phase 2) treating participants with increasing doses of telisotuzumab adizutecan with FOLFOX. Participants will then be randomized into 3 groups called treatment

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Have unresectable, metastatic histologically- or cytologically-confirmed adenocarcinoma of the pancreas * Have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 * Must consent to provide archived or recently obtained tumor tissue during Screening * Have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Exclusion Criteria: * Have prior systemic therapy, surgery, or radiation (except palliative radiation) in the unresectable, locally advanced or metastatic setting * Prior c-MET targeting therapy * History of interstitial lung disease (ILD) or pneumonitis that required treatment with systemic steroids, or any evidence of active ILD/pneumonitis 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. * Prior bone marrow transplant, solid organ transplant, or previous clinical diagnosis of tuberculosis.
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What it tests

  • Telisotuzumab adizutecan
  • Fluorouracil
  • Folinic acid/ Leucovorina
  • Oxaliplatin
  • Irinotecan
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Where

22 sites
Smilow Cancer Center At Yale-New Haven /ID# 279780
New Haven, United States
University of Chicago Medical Center /ID# 279460
Chicago, United States
City Of Hope - Chicago /ID# 279814
Zion, United States
Cancer And Hematology Centers Of Western Michigan - Grand Rapids /ID# 279853
Grand Rapids, United States
Washington University /ID# 279890
St Louis, United States
UH Seidman Cancer Center /ID# 279602
Cleveland, United States
University of Pennsylvania - Perelman Center for Advanced Medicine /ID# 280038
Philadelphia, United States
Texas Oncology - Northeast Texas /ID# 280417
Tyler, United States

โ€ฆand 14 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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