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Telisotuzumab adizutecan with FOLFOX for first treatment of metastatic pancreatic cancer

Tests telisotuzumab adizutecan plus FOLFOX against standard treatment in adults with metastatic pancreatic cancer.

Key facts

Who runs it
AbbVie Deutschland GmbH & Co. KG
Where
Dresden, Essen, Hamburg, and Ulm, GermanySee the 4 sitesAlso in 5 other countries, 21 sites
Registry title
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
Status
Not yet recruiting
Phase
Phase 2/3
People taking part
194 people, planned
Starts
4 Jan 2027
Expected to end
15 Jul 2031
Type of study
Interventional
Record updated
16 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with pancreatic cancer that has spread and cannot be removed by surgery. They must not have had earlier drug treatment for this stage.

Age
18 years or older
Sex
Men and women
Disease stage
Pancreatic ductal adenocarcinoma that has spread (metastatic) and cannot be removed by surgery, confirmed by tissue or cell tests. The cancer must be measurable on scans (RECIST v1.1).
Earlier treatment
No earlier drug therapy, surgery or radiation (except radiation to ease symptoms) for the unresectable, locally advanced or metastatic cancer. No earlier treatment that targets c-MET.
Biomarker or test result
Must agree to give stored or newly taken tumor tissue during screening.

Main reasons for not taking part

  • Earlier drug therapy, surgery or radiation for unresectable, locally advanced or spread cancer (except radiation to ease symptoms)
  • Earlier c-MET targeting treatment
  • History of interstitial lung disease or pneumonitis treated with steroids, or signs of it on the screening chest CT scan
  • Earlier bone marrow or solid organ transplant
  • Earlier diagnosis of tuberculosis

The registry criteria, word for word

Show all 8 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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 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 in Germany

Also in 5 other countries, 21 sites

  • Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöRDresden, GermanyNot yet recruiting
  • Universitaetsklinikum Essen (AoR)Essen, GermanyNot yet recruiting
  • University Medical Center Hamburg-EppendorfHamburg, GermanyNot yet recruiting
  • Universitaetsklinikum Ulm AoRUlm, GermanyNot yet recruiting

About the trial

What the trial wants to find out

Phase 2: • To evaluate the safety and tolerability of telisotuzumab adizutecan in combination with FOLFOX • To evaluate the efficacy of telisotuzumab adizutecan in combination with FOLFOX as measured by Objective Response (OR) per Blinded Independent Central Review (BICR) • To optimize and select the recommended Phase 3 dose (RP3D) of telisotuzumab adizutecan in combination with FOLFOX

Read full original descriptionShow less

Phase 3: • To evaluate the efficacy of telisotuzumab adizutecan in combination with FOLFOX compared with standard of care as measured by OR per BICR assessment and by Overall Survival (OS)

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Official title
Phase 2/3 Open Label Randomized Study of Telisotuzumab Adizutecan in Combination with FOLFOX Compared to Standard of Care in Subjects with First-Line Metastatic Pancreatic Ductal Adenocarcinoma - AndroMETa-PDAC-288
Plain-language title
Telisotuzumab adizutecan with FOLFOX for first treatment of metastatic pancreatic cancerGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 9 November 2026.
Record updated
16 October 2026