DESTINY-Biliary Tract Cancer-01 is a phase 3 trial evaluating trastuzumab deruxtecan (T-DXd) and rilvegostomig versus the standard regimen of gemcitabine, cisplatin, and durvalumab in patients with HER2-expressing, locally advanced or metastatic biliary tract cancer.
The study aims to assess the efficacy and safety of the investigational combination in the first-line setting.
Eligible participants are adults with unresectable or metastatic disease and confirmed HER2 expression.
Molecular status is verified during screening.
Participants receive either the investigational agents or standard-of-care therapy.
Secondary endpoints include safety measures and additional efficacy outcomes.
The DESTINY-Biliary Tract Cancer-01 study tests two new antibody-based cancer medicines (trastuzumab deruxtecan and rilvegostomig) in people with HER2-positive biliary tract cancer that cannot be removed surgically or has spread.
The goal is to find out how effective and safe this new treatment is compared with the current standard therapy of gemcitabine, cisplatin, and durvalumab.
Adults with advanced, HER2-positive biliary tract cancer can take part.
HER2 status is checked before joining the study.
Participants receive either the new combination treatment or the standard therapy.
The study also looks at other important aspects such as safety and disease control.
