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NCT07490301

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
AbbVie
~900 participants
Updated 2026-08-03 on ClinicalTrials.gov
What's tested:Telisotuzumab adizutecanFluorouracilFolinic acid/ LeucovorinaOxaliplatinIrinotecan

At a glance

Recruiting sites
16 of 21 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Phase 2 and Phase 3: Overall Response (OR) Assessed by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Measured over through study completion, approximately 6 years
+1 more outcome measured

Conditions

Metastatic Pancreatic Ductal Adenocarcinoma
PDAC

Explore related trials

Pancreatic Ductal Adenocarcinoma

Where it's being run

21 sites across 14 states
Taiwan3
Illinois2
New South Wales2
Victoria2
Tel Aviv2
Israel2
Michigan1
Texas1

Study leadership

  • ABBVIE INC. · STUDY_DIRECTOR · AbbVie

Who to contact

ABBVIE CALL CENTER
[email protected]
844-663-3742
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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Phase 2 and Phase 3: Overall Response (OR) Assessed by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1through study completion, approximately 6 years

    OR is defined as participants achieving a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR) assessed by BICR per RECIST v1.1.

  • Phase 3: Overall Survival (OS)through study completion, approximately 6 years

    OS is defined as the time from date of randomization to the death from any cause.