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Study identifier: NCT07490301 Synced from ClinicalTrials.gov · August 06, 2026
● Study status: Recruiting

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

Condition: Metastatic Pancreatic Ductal Adenocarcinoma · PDAC  ·  Sponsor: AbbVie

PhasePhase 2/Phase 3
Planned participants900
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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 arms. Two groups will receive telisotuzumab adizutecan with FOLFOX with different optimized doses. One group will receive standard of care (SOC) - fluorouracil, leucovorin, oxaliplatin, and irinotecan. In the second phase (Phase 3), participants will be randomized into 2 arms to receive either the optimal dose of telisotuzumab adizutecan (from the previous phase) with FOLFOLX, or SOC. Approximately 900 participants with PDAC will be enrolled in this study in approximately 200 sites worldwide. Phase 2 includes a dose escalation stage and a dose optimization stage. In the dose escalation stage,…

This description comes directly from the study's public registry record.

Talk to the study team

ABBVIE CALL CENTER  ·  844-663-3742  ·  abbvieclinicaltrials@abbvie.com

Always discuss trial participation with your own doctor first.

Locations (21)

University of Chicago Medical Center /ID# 279460Chicago, Illinois, United StatesRecruiting
City Of Hope - Chicago /ID# 279814Zion, Illinois, United StatesRecruiting
Cancer And Hematology Centers Of Western Michigan - Grand Rapids /ID# 279853Grand Rapids, Michigan, United StatesRecruiting
Texas Oncology - Northeast Texas /ID# 280417Tyler, Texas, United StatesRecruiting
Virginia Cancer Specialists - Fairfax /ID# 280415Fairfax, Virginia, United StatesRecruiting
Tamworth Hospital /ID# 280099North Tamworth, New South Wales, AustraliaNot Yet Recruiting
Prince Of Wales Hospital - Randwick /ID# 280085Randwick, New South Wales, AustraliaNot Yet Recruiting
Monash Health - Monash Medical Centre - Clayton /ID# 280076Clayton, Victoria, AustraliaNot Yet Recruiting
Austin Hospital /ID# 280283Melbourne, Victoria, AustraliaRecruiting
Fiona Stanley Hospital /ID# 280079Murdoch, Western Australia, AustraliaNot Yet Recruiting
The Chaim Sheba Medical Center /ID# 279408Ramat Gan, Tel Aviv, IsraelRecruiting
Tel Aviv Sourasky Medical Center /ID# 279414Tel Aviv, Tel Aviv, IsraelRecruiting

+ 9 more locations — full list on the registry record.

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