Zanidatamab — 2L+ HER2-amplified biliary tract cancer (HERIZON-BTC-01)
Deterministic view of the source YAML entity. Clinical authority remains with the cited source IDs and reviewer sign-off state.
Knowledge-base record for audit. Provisional clinical content: this is not a prescription. An oncologist must verify original sources, applicability and review status. Full rules and constraints are in the YAML.
| Components | DRUG-ZANIDATAMAB |
|---|
| ID | REG-ZANIDATAMAB |
|---|---|
| Type | Regimen |
| Status | reviewed 2026-05-08 | pending_clinical_signoff |
| Diseases | None declared |
| Sources | SRC-ESMO-BTC-2023 SRC-HERIZON-BTC-01-HARDING-2023 SRC-NCCN-HEPATOBILIARY |
Notes
HERIZON-BTC-01 (Harding et al., Lancet Oncol 2023; NCT04466891): single-arm phase 2b trial of zanidatamab 20 mg/kg IV q2w in HER2- amplified (IHC 3+ or IHC 2+/ISH+) unresectable / locally advanced / metastatic biliary tract cancer progressed on prior gemcitabine- based therapy; primary efficacy cohort 1 (HER2 IHC 3+ or IHC 2+/ISH+) n=87 — confirmed ORR per independent central review 41.3% (95% CI 30.4-52.8); DCR 68.8%; median DoR 14.9 mo. Treatment-related Grade ≥3 AEs in 18%; no treatment-related deaths. Most common AEs: diarrhea (~40%), infusion-related reactions (~33%), nausea, fatigue. Single-arm phase 2b — evidence tier 2 / moderate (no randomised comparator). FDA accelerated approval November 2024 for previously treated HER2-positive (IHC 3+) BTC. NCCN category 2A; ESCAT tier IIA (FDA-approved disease-specific). Confirmatory phase 3 (HERIZON-GEA-01 in HER2+ gastric/GEJ) and ongoing BTC studies pending. UA access: named-patient / EAP only as of 2026-05.
Used By
Indication
IND-CHOLANGIO-2L-HER2-ZANIDATAMAB- IND-CHOLANGIO-2L-HER2-ZANIDATAMAB