{"entity":{"id":"herizon-btc-302","kind":"trial","name":"HERIZON-BTC-302","aka":[],"tldr":"Tests whether the HER2 bispecific antibody should be given from the start in HER2-positive bile duct cancer.","summary":"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.","status":"recruiting","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT06282575","url":"https://clinicaltrials.gov/study/NCT06282575"},{"label":"Post-hoc HERIZON-BTC-01 analysis","url":"https://www.ccanewsonline.com/issues/2026/march-2026-vol-7-no-1/zanidatamab-improves-survival-outcomes-in-her2-positive-biliary-tract-cancer-post-hoc-herizon-btc-01-analysis"}],"tags":[],"related":[],"cancers":["cholangiocarcinoma","gallbladder"],"sections":[],"technologies":["bispecific-antibody"],"targets":["her2"],"drugs":["zanidatamab","gemcitabine-cisplatin"],"companies":["jazz","zymeworks"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["Gallbladder cancer: the confirmatory first-line trial for zanidatamab; 286 patients planned, primary completion 2028-12-01 (registry). UK sites (5): Mount Vernon Cancer Centre (London), Royal Marsden (London and Surrey), The Christie (Manchester), Western General Hospital Edinburgh Cancer Centre. Given that 53 percent of HERIZON-BTC-01 patients had gallbladder cancer, this is the phase 3 most likely to report a gallbladder-dominated HER2 result."],"nct":"NCT06282575","phase":"3","setting":"First-line HER2-positive advanced biliary tract cancer: zanidatamab + standard of care (GemCis ± PD-1) vs standard of care","sponsor":"Jazz / Zymeworks","started":"2024-07-19","startedType":"actual","enrolledBasis":"registry","outcomes":[]},"route":"/trials/herizon-btc-302/","neighbours":{"cancer":[{"id":"cholangiocarcinoma","kind":"cancer","name":"Biliary tract cancer (cholangiocarcinoma)","route":"/cancers/cholangiocarcinoma/"},{"id":"extrahepatic-cholangiocarcinoma","kind":"cancer","name":"Extrahepatic cholangiocarcinoma (perihilar and distal)","route":"/cancers/extrahepatic-cholangiocarcinoma/"},{"id":"gallbladder","kind":"cancer","name":"Gallbladder cancer","route":"/cancers/gallbladder/"}],"technology":[{"id":"bispecific-antibody","kind":"technology","name":"Bispecific antibodies","route":"/technologies/bispecific-antibody/"}],"target":[{"id":"btc","kind":"target","name":"BTC","route":"/targets/btc/"},{"id":"her2","kind":"target","name":"HER2","route":"/targets/her2/"}],"drug":[{"id":"gemcitabine-cisplatin","kind":"drug","name":"Gemcitabine + cisplatin","route":"/drugs/gemcitabine-cisplatin/"},{"id":"zanidatamab","kind":"drug","name":"Zanidatamab","route":"/drugs/zanidatamab/"}],"company":[{"id":"jazz","kind":"company","name":"Jazz Pharmaceuticals","route":"/companies/jazz/"},{"id":"zymeworks","kind":"company","name":"Zymeworks","route":"/companies/zymeworks/"}],"term":[{"id":"trial-or-standard-treatment-biliary","kind":"term","name":"A clinical trial or standard treatment for gallbladder cancer","route":"/terms/trial-or-standard-treatment-biliary/"},{"id":"gallbladder-cancer-in-biliary-trials","kind":"term","name":"Gallbladder cancer in biliary tract cancer trials (eligibility and subgroups)","route":"/terms/gallbladder-cancer-in-biliary-trials/"}],"trial":[{"id":"herizon-btc-01","kind":"trial","name":"HERIZON-BTC-01","route":"/trials/herizon-btc-01/"}],"roadmap":[{"id":"gallbladder-cancer-roadmap","kind":"roadmap","name":"Gallbladder cancer roadmap: from a chance finding at gallstone surgery to a disease with its own trials","route":"/roadmaps/gallbladder-cancer-roadmap/"}],"idea":[{"id":"idea-gbc-reflex-her2-testing-advanced-biliary","kind":"idea","name":"Reflex HER2 testing of every advanced gallbladder and extrahepatic biliary cancer","route":"/ideas/idea-gbc-reflex-her2-testing-advanced-biliary/"}]}}