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
EU CTIS ID: 2025-522563-15-00
What this study is testing
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)
- Phase II and Phase III (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Canada
- United States
- Israel
- China
- Australia
- Korea, Republic of
- Japan
- Brazil
- Taiwan
- India
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Canada; United States; Israel; China; Australia; Korea, Republic of and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.