2025-522563-15-00Not yet recruitingPhase 2/3
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
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
Source: EU CTIS (euclinicaltrials.eu) · Last updated 16 Oct 2026
Brief summary (registry, in English)
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 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)
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 194 (estimated)
- First submitted
- 17 Mar 2026
- Start date
- 4 Jan 2027
- Lead sponsor
- AbbVie Deutschland GmbH & Co. KG
- Diseases
- Pancreatic cancer
- EU CT number
- 2025-522563-15-00
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 194
- 25 sites in 6 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (25)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ordensklinikum Linz GmbH | Linz | Austria | Not yet recruiting |
| Gemeinnuetzige Salzburger Landeskliniken Betriebsgesellschaft mbH | Salzburg | Austria | Not yet recruiting |
| Medical University of Vienna | Vienna | Austria | Not yet recruiting |
| Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR | Dresden | Germany | Not yet recruiting |
| Universitaetsklinikum Essen (AoR) | Essen | Germany | Not yet recruiting |
| University Medical Center Hamburg-Eppendorf | Hamburg | Germany | Not yet recruiting |
| Universitaetsklinikum Ulm AoR | Ulm | Germany | Not yet recruiting |
| Hospital Universitari Vall d'Hebron | Barcelona | Spain | Not yet recruiting |
| Hospital Universitario HM Sanchinarro | Madrid | Spain | Not yet recruiting |
| Hospital General Universitario Gregorio Marañón | Madrid | Spain | Not yet recruiting |
| Hospital Universitario Fundación Jiménez Díaz | Madrid | Spain | Not yet recruiting |
| Hospital Universitario Miguel Servet | Zaragoza | Spain | Not yet recruiting |
| Centre Hospitalier Universitaire de Dijon | Dijon | France | Not yet recruiting |
| Centre Hospitalier Universitaire de Lille | Lille | France | Not yet recruiting |
| Institut Paoli-Calmettes | Marseille | France | Not yet recruiting |
| Hospital Hotel Dieu | Nantes | France | Not yet recruiting |
| Hopitaux Universitaires Pitie Salpetriere | Paris | France | Not yet recruiting |
| Hopital Paul Brousse | Villejuif Cedex | France | Not yet recruiting |
| Istituto Europeo di Oncologia s.r.l | Milan | Italy | Not yet recruiting |
| Humanitas Mirasole S.p.A. | Rozzano | Italy | Not yet recruiting |
| Centro Ricerche Cliniche di Verona s.r.l. | Verona | Italy | Not yet recruiting |
| Unidade Local De Saude De Santa Maria E.P.E. | Lisbon | Portugal | Not yet recruiting |
| Champalimaud Clinical Centre | Lisbon | Portugal | Not yet recruiting |
| Instituto Portugues de Oncologia do Porto Francisco Gentil, E.P.E. | Porto | Portugal | Not yet recruiting |
| Unidade Local de Saude de Sao Joao E.P.E. | Porto | Portugal | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.