M25-288 Pancreatic Ductal Adenocarcinoma:Telisotuzumab Adizutecan & FOLFOX Phase2/3 Study - PDAC-288
Research type
Research Study
Full title
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
IRAS ID
1013191
Contact name
Bernhard Dodell
Contact email
Sponsor organisation
AbbVie Deutschland GmbH & Co. KG
Research summary
This is a Phase 2 (Part 1) and Phase 3 (Part 2), open-label, randomized study of telisotuzumab adizutecan + FOLFOX in patients with pancreatic cancer. Phase 2 studies test potential new treatments in a small number of patients with a condition or disease, and Phase 3 studies test potential new treatments in a large number of patients with a condition or disease. This study is open-label, which means that both patients and study doctors know which study treatment is given to patients. A computer program is used to randomly (by chance) put the patients into groups. This process is called randomization, which helps make the groups similar and reduces the differences between the groups.
Telisotuzumab adizutecan is an investigational drug (also called an experimental drug, is a medicine being studied to see if it improves a disease or medical condition) called an ADC. ADCs work by targeting cancer cells with an antibody (protein made in the body in response to a foreign substance) that carries a drug that kills the cancer cells while avoiding killing normal cells as much as possible. Potential risks of ADCs may include anemia (low red blood cell counts), low white blood cell counts (cells that help fight infection), thrombocytopenia (decrease in the number of platelets in the blood, which help stop bleeding), nausea, tiredness, and vomiting. This study also includes treatment with fluorouracil, leucovorin, oxaliplatin, and irinotecan and patients should discuss potential risks with the study doctor.
There may be more responsibility for patients in this study compared to patients receiving standard of care treatment. Patients will attend regular visits during the study at a hospital or clinic. The effects of treatment will be checked by medical assessments, blood tests, checking for side effects, and completing questionnaires.REC name
London - Hampstead Research Ethics Committee
REC reference
26/LO/0285
Date of REC Opinion
15 May 2026
REC opinion
Further Information Favourable Opinion