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โ† Trials
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A Study to Assess Adverse Events and Change in Disease Activity With Treatment Combinations With Telisotuzumab Adizutecan in Adults Participants With Pancreatobiliary Cancers

RecruitingPhase 2Ages 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 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. Telisotuzumab 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 appro

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

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) Performance status (PS) of 0 or 1. * Resolution of any acute clinically significant treatment-related toxicity from prior therapy to Grade \<= 1 prior to study entry (except for alopecia of any grade). * 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. Exclusion Criteria: * Prior cellular-Mesenchymal Epithelial Transition (c-MET) protein 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. * Has had major surgery or significant traumatic injury within 28 days prior to randomization/enrollment, or anticipation of the need for major surgery during the course of study intervention. Placement of biliary stent/tube is permitted.
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What it tests

  • Telisotuzumab Adizutecan
  • Gemcitabine
  • Nab-Paclitaxel
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Where

7 sites
Hattiesburg Clinic /ID# 281952
Hattiesburg, United States
The Chaim Sheba Medical Center /ID# 281618
Ramat Gan, Israel
Hadassah Medical Center-Hebrew University /ID# 281620
Jerusalem, Israel
Kanagawa Cancer Center /ID# 281899
Yokohama, Japan
Osaka International Cancer Institute /ID# 281900
Osaka, Japan
National Cancer Center Hospital /ID# 281870
Chuo-Ku, Japan
China Medical University Hospital /ID# 281981
Taichung, Taiwan
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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