Zanidatamab — cáncer de tracto biliar amplificado con 2L+ HER2 (HERIZON-BTC-01)
Vista determinista de la entidad fuente YAML. La autoridad clínica sigue con los ID de fuente citados y estado de firma del revisor.
Registro de base de conocimiento para la auditoría. Contenido clínico provisional: esto no es una prescripción. Un oncólogo debe verificar fuentes originales, aplicabilidad y estado de revisión.
Fuente YAML: registro completo
| Componentes | DRUG-ZANIDATAMAB |
|---|
| ID | REG-ZANIDATAMAB |
|---|---|
| Tipo | Esquema terapéutico |
| Situación | reviewed 2026-05-08 | pending_clinical_signoff |
| Enfermedades | Ninguna declarada |
| Fuentes | SRC-ESMO-BTC-2023 SRC-HERIZON-BTC-01-HARDING-2023 SRC-NCCN-HEPATOBILIARY |
Notas
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.
Utilizado por
Indicación
IND-CHOLANGIO-2L-HER2-ZANIDATAMAB- IND-CHOLANGIO-2L-HER2-ZANIDATAMAB