zanidatamab   Click here for help

GtoPdb Ligand ID: 13627

Synonyms: zanidatamab-hrii | Ziihera® | ZW-25 | ZW25
Approved drug
zanidatamab is an approved drug (DA (2024))
Compound class: Antibody
Comment: Zanidatamab (ZW25) is an anti-ERBB2 (HER2) monoclonal antibody [3]. It is biparatopic, meaning that it interacts with two independent extracellular epitopes on the ERBB2 receptor. Antibody binding induces ERBB2 internalisation, as well as CDC, ADCC and ADCP. The two epitopes are those bound by trastuzumab (ECD4) and pertuzumab (ECD2). Zanidatamab was designed to treat ERBB2 over-expressing advanced solid tumours, in particular types other than breast cancer [4].
No information available.
Summary of Clinical Use Click here for help
Zanidatamab's first approval was granted by the FDA in November 2024 (accelerated approval), to treat previously treated, unresectable or metastatic ERBB2-positive biliary tract cancer [2]. Continued approval for this indication will be determined by the outcomes of the phase 3 HERIZON-BTC-302 trial (NCT06282575). The EMA issued zanidatamab orphan designation in November 2020 (EU/3/20/2353), for the treatment of gastric cancer.
Clinical Trials
Clinical Trial ID Title Type Source Comment References
NCT05152147 A Study of Zanidatamab in Combination With Chemotherapy Plus or Minus Tislelizumab in Patients With HER2-positive Advanced or Metastatic Gastric and Esophageal Cancers Phase 3 Interventional Jazz Pharmaceuticals
NCT06695845 A Phase 2 Study of Zanidatamab in Patients With HER2-expressing Tumors Phase 2 Interventional Jazz Pharmaceuticals
NCT06282575 Efficacy and Safety of Zanidatamab With Standard-of-care Therapy Against Standard-of-care Therapy for Advanced HER2-positive Biliary Tract Cancer Phase 3 Interventional Jazz Pharmaceuticals The HERIZON-BTC-302 study.
NCT04466891 A Study of ZW25 (Zanidatamab) in Subjects With Advanced or Metastatic HER2-Amplified Biliary Tract Cancers Phase 2 Interventional Jazz Pharmaceuticals 1