Study on Treatment Combinations with Telisotuzumab Adizutecan for Adults with Pancreatic and Biliary Cancers
Sponsor: AbbVie
ClinicalTrials ID:NCT07769502
This clinical trial is testing the safety and effectiveness of a new drug, telisotuzumab adizutecan, combined with other cancer treatments for adults with pancreatic and biliary cancers. The study will compare different doses of the new drug with standard treatments to see which works best.
Patient Parameters
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Program Overview
Pancreatic cancer often begins in the ducts of the pancreas, a gland behind the stomach that helps with digestion. This study aims to test a new drug, telisotuzumab adizutecan, in combination with other cancer drugs, gemcitabine and nab-paclitaxel, to see if it is safe and effective for treating pancreatic and biliary cancers. Participants will be divided into two groups: one will receive different doses of the new drug with gemcitabine, and the other will receive standard treatment with gemcitabine and nab-paclitaxel. The study will take place over about three years at around 50 locations worldwide, involving about 168 participants. Participants will have regular check-ups, including medical assessments, blood tests, and questionnaires, to monitor the treatment's effects and any side effects.
Eligibility Criteria
Inclusion Criteria
- Must be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Any side effects from previous treatments must have improved to a mild level before starting the study, except for hair loss.
- Must have measurable cancer based on specific medical criteria, even if the cancer is in an area that was previously treated with radiation, as long as it has shown signs of growth.
Exclusion Criteria
- Cannot have had previous treatments targeting the c-MET protein.
- Cannot have a history of lung diseases like interstitial lung disease or pneumonitis that required treatment with steroids, or show any signs of these conditions on a chest scan.
- Cannot have had major surgery or a serious injury within 28 days before starting the study, or expect to need major surgery during the study. However, having a biliary stent or tube placed is allowed.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Hattiesburg Clinic /ID# 281952 | 39401 | Hattiesburg | Mississippi |
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