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
NCT07490301Phase 2/3Recruiting
- Lead sponsor
- AbbVie (Industry)
- Enrollment
- 900 (estimated)
- Start date
- 30 Apr 2026
- Primary completion
- Jun 2031 (estimated)
- Study completion
- 1 Jun 2031
- Last update posted
- 13 Oct 2026
Design
- Study type
- Interventional
- Primary purpose
- Treatment
- Allocation
- Randomized
- Intervention model
- Sequential
- Masking
- None
- Arms
- 6
Interventions
- Telisotuzumab adizutecan Drug
- Fluorouracil Drug
- Folinic acid/ Leucovorina Drug
- Oxaliplatin Drug
- Irinotecan Drug
Conditions and primary outcome
- Metastatic Pancreatic Ductal Adenocarcinoma
- PDAC
Primary outcome
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 (through study completion, approximately 6 years); Phase 3: Overall Survival (OS) (through study completion, approximately 6 years)
Posted results on ClinicalTrials.gov
Results posted on ClinicalTrials.gov: No
Results from company and journal sources
No editor-confirmed results are on record for this study.
Publications
No PubMed citation lists NCT07490301.
CT-VCA trial quality
About CT-VCALoading CT-VCA scores…
Data integrity
Compare what the registry, company releases, FDA documents and publications say about this study.
Drugs on HealthTrade
Source
- NCT07490301 on ClinicalTrials.gov (opens in a new tab) Licence: public-domain. Read
Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.
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