# HERIZON-BTC-302

Source: https://onco.cc/trials/herizon-btc-302/  
OnCo record `herizon-btc-302` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Fields

- Kind: Trial
- Status: recruiting
- Last checked: 2026-09-07
- Registry id: 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

## 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.

## Sources

- ClinicalTrials.gov NCT06282575: https://clinicaltrials.gov/study/NCT06282575
- Post-hoc HERIZON-BTC-01 analysis: 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

## Connected records

- cancers: [Biliary tract cancer (cholangiocarcinoma)](https://onco.cc/cancers/cholangiocarcinoma/), [Extrahepatic cholangiocarcinoma (perihilar and distal)](https://onco.cc/cancers/extrahepatic-cholangiocarcinoma/), [Gallbladder cancer](https://onco.cc/cancers/gallbladder/)
- technologies: [Bispecific antibodies](https://onco.cc/technologies/bispecific-antibody/)
- targets: [BTC](https://onco.cc/targets/btc/), [HER2](https://onco.cc/targets/her2/)
- drugs: [Gemcitabine + cisplatin](https://onco.cc/drugs/gemcitabine-cisplatin/), [Zanidatamab](https://onco.cc/drugs/zanidatamab/)
- companies: [Jazz Pharmaceuticals](https://onco.cc/companies/jazz/), [Zymeworks](https://onco.cc/companies/zymeworks/)
- terms: [A clinical trial or standard treatment for gallbladder cancer](https://onco.cc/terms/trial-or-standard-treatment-biliary/), [Gallbladder cancer in biliary tract cancer trials (eligibility and subgroups)](https://onco.cc/terms/gallbladder-cancer-in-biliary-trials/)
- trials: [HERIZON-BTC-01](https://onco.cc/trials/herizon-btc-01/)
- roadmaps: [Gallbladder cancer roadmap: from a chance finding at gallstone surgery to a disease with its own trials](https://onco.cc/roadmaps/gallbladder-cancer-roadmap/)
- ideas: [Reflex HER2 testing of every advanced gallbladder and extrahepatic biliary cancer](https://onco.cc/ideas/idea-gbc-reflex-her2-testing-advanced-biliary/)

---
JSON: https://onco.cc/api/v1/entities/herizon-btc-302.json