Tests whether the HER2 bispecific antibody should be given from the start in HER2-positive bile duct cancer.
HERIZON-BTC-302, trial NCT06282575 sponsored by Jazz and Zymeworks, tests whether the HER2 bispecific antibody zanidatamab should be given from the start in HER2-positive advanced biliary tract cancer, added to gemcitabine and cisplatin with or without PD-1 blockade. It is the confirmatory trial for zanidatamab's accelerated approval, which rested on the single-arm HERIZON-BTC-01 study, where about forty percent of patients responded and those with the highest HER2 expression responded most often; enrolment has been under way since 2024 with no results. OnCo links it to biliary tract and gallbladder cancer, HER2 as a target, zanidatamab and gemcitabine plus cisplatin. Whether HER2-directed therapy moves from later lines into first-line treatment for this rare subgroup is the question it will answer.
Shares Zymeworks, Reflex HER2 testing of every advanced gallbladder and extrahepatic biliary cancer, HERIZON-BTC-01, Jazz Pharmaceuticals.
Shares Reflex HER2 testing of every advanced gallbladder and extrahepatic biliary cancer, HERIZON-BTC-01, Zanidatamab, Extrahepatic cholangiocarcinoma (perihilar and distal).
Shares A clinical trial or standard treatment for gallbladder cancer, Gemcitabine + cisplatin, Extrahepatic cholangiocarcinoma (perihilar and distal), Gallbladder cancer roadmap: from a chance finding at gallstone surgery to a disease with its own trials.
Shares Zymeworks, Zanidatamab, HER2, Gallbladder cancer.
Shares Gemcitabine + cisplatin, Extrahepatic cholangiocarcinoma (perihilar and distal), Gallbladder cancer in biliary tract cancer trials (eligibility and subgroups), Bispecific antibodies.
Shares Gemcitabine + cisplatin, Extrahepatic cholangiocarcinoma (perihilar and distal), Gallbladder cancer roadmap: from a chance finding at gallstone surgery to a disease with its own trials, Gallbladder cancer in biliary tract cancer trials (eligibility and subgroups).
Shares Extrahepatic cholangiocarcinoma (perihilar and distal), Gallbladder cancer in biliary tract cancer trials (eligibility and subgroups), Bispecific antibodies, Biliary tract cancer (cholangiocarcinoma).
Shares A clinical trial or standard treatment for gallbladder cancer, Gemcitabine + cisplatin, Extrahepatic cholangiocarcinoma (perihilar and distal), Gallbladder cancer roadmap: from a chance finding at gallstone surgery to a disease with its own trials.