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
Key facts
- Where
- Dijon, Lille, Marseille, Nantes, Paris és Villejuif Cedex, FranciaországSee the 6 sites
- Phase
- 2/3. fázis
Where in Franciaország
- Centre Hospitalier Universitaire de DijonDijon, FranciaországToborzás még nem indult
- Centre Hospitalier Universitaire de LilleLille, FranciaországToborzás még nem indult
- Institut Paoli-CalmettesMarseille, FranciaországToborzás még nem indult
- Hospital Hotel DieuNantes, FranciaországToborzás még nem indult
- Hopitaux Universitaires Pitie SalpetriereParis, FranciaországToborzás még nem indult
- Hopital Paul BrousseVillejuif Cedex, FranciaországToborzás még nem indult
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- AbbVie Deutschland GmbH & Co. KG
- Trial code
- EU 2025-522563-15-00
- Record updated
- 2026. október 16.
- Original description
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 FOLFOXRead full original descriptionShow less
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
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)
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 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.