Telisotuzumab adizutecan with FOLFOX versus standard care in first-line metastatic pancreatic cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multi-arm Phase 2/Phase 3 trial evaluating telisotuzumab adizutecan in combination with FOLFOX as a first-line therapy for metastatic pancreatic ductal adenocarcinoma. Participants receive escalating doses in Phase 2, then are randomized to treatment arms with optimized telisotuzumab adizutecan dosing plus FOLFOX versus comparators. The study monitors safety and disease activity using RECIST 1.1 criteria and standard clinical endpoints. Eligibility requires confirmed metastatic PDAC, good performance status, and willingness to provide tumor tissue for analysis. Exclusion criteria include prior systemic therapy for metastatic disease and certain lung or transplant histories.

Why it matters

Who can join: the full rules

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.

Where it's running

• Smilow Cancer Center At Yale-New Haven /ID# 279780
  New Haven, Connecticut, United States Recruiting
• University of Chicago Medical Center /ID# 279460
  Chicago, Illinois, United States Recruiting
• City Of Hope - Chicago /ID# 279814
  Zion, Illinois, United States Recruiting
• Cancer And Hematology Centers Of Western Michigan - Grand Rapids /ID# 279853
  Grand Rapids, Michigan, United States Recruiting
• Washington University /ID# 279890
  St Louis, Missouri, United States Recruiting
• UH Seidman Cancer Center /ID# 279602
  Cleveland, Ohio, United States Recruiting

Study contacts

• Study coordinator: Abbvie Call Center
• Email: abbvieclinicaltrials@abbvie.com
• Phone: 844-663-3742

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.