Summary
Cancer is a condition where cells in a specific part of the body grow and multiply uncontrollably. The pancreas is a gland behind the stomach that produces digestive fluids that are emptied into the intestines through tube-shaped ducts. Pancreatic cancer often starts in these ducts.
This study is testing a drug called telisotuzumab adizutecan when given with chemotherapy to treat metastatic pancreatic ductal adenocarcinoma (PDAC).
Who can take part?
You may be eligible for this study if:
- you have pancreatic ductal adenocarcinoma (PDAC)
- your cancer is unresectable or metastatic
- you have not had any prior treatment for your advanced disease. Prior treatment for an earlier stage of disease is allowed.
The study is divided into two parts:
Phase 2
Researchers will first test different doses of telisotuzumab adizutecan together with standard chemotherapy called FOLFOX.
Once suitable doses have been identified, participants will be randomly assigned (by chance) to one of three treatment groups:
- Telisotuzumab adizutecan plus FOLFOX at one dose level
- Telisotuzumab adizutecan plus FOLFOX at another dose level
- Standard treatment (FOLFIRINOX chemotherapy), which includes fluorouracil, leucovorin, oxaliplatin and irinotecan
Phase 3
Participants will be randomly assigned to receive either:
- The preferred dose of telisotuzumab adizutecan plus FOLFOX identified in Phase 2, or
- Standard treatment (FOLFIRINOX)
What does participation involve?
If you join this study, you will:
- Receive treatment through a drip into a vein (intravenous infusion)
- Attend regular hospital or clinic visits
- Have medical check-ups and physical examinations
- Have blood tests and other assessments to monitor your health and cancer
- Be asked to complete questionnaires about your health and wellbeing
- Have the effects of treatment checked regularly through medical assessments, blood tests, questionnaires and monitoring for side effects
The study is expected to run for about 6 years. Taking part in this study may require more visits, tests and assessments than standard treatment.