Evaluating Intravenous Telisotuzumab Adizutecan with FOLFOX Versus Standard Chemotherapy for First-Time Metastatic Pancreatic Ductal Adenocarcinoma in Adults

What this Trial Is About

Researchers are studying an investigational drug called telisotuzumab adizutecan combined with fluorouracil, folinic acid, and oxaliplatin FOLFOX to treat adults with metastatic pancreatic ductal adenocarcinoma, a type of pancreatic cancer that often starts in the ducts of the pancreas. This study aims to assess side effects and changes in disease activity using this combination compared to standard care treatments. The trial includes both Phase 2 and Phase 3 stages to find optimal dosing and compare treatments. In Phase 2, participants receive escalating doses of intravenous telisotuzumab adizutecan with FOLFOX or standard of care SOC treatments, then are randomized into groups receiving different doses or SOC. In Phase 3, participants are randomized to receive either the optimal dose of telisotuzumab adizutecan with FOLFOX or SOC, which includes fluorouracil, leucovorin, oxaliplatin, and irinotecan. Both phases involve treatment periods of about 2 years, with the entire study lasting approximately 6 years. Participants will attend regular visits at approved hospitals or clinics for medical assessments, blood tests, and questionnaires to monitor treatment effects and side effects. Researchers will measure outcomes such as tumor response, overall survival, progression-free survival, and quality of life using validated scales. Frequent monitoring and safety assessments will be conducted throughout the study to evaluate the treatments impact over time.

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