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ZW25 (Zanidatamab)

DRUG4 trials

Sponsors

Jazz Pharmaceuticals

Conditions

HER2+/HR+ Breast CancerHER2-amplified Biliary Tract CancersHER2-expressing CancersHER2-expressing Gastrointestinal Cancers, Including Gastroesophageal Adenocarcinoma, Biliary Tract Cancer, and Colorectal Cancer

Phase 1

Trial of ZW25 (Zanidatamab) in Patients With Advanced HER2-expressing Cancers
CompletedNCT02892123
Jazz PharmaceuticalsHER2-expressing Cancers
Start: 2016-09-30End: 2024-10-31Updated: 2024-11-27

Phase 2

A Safety and Efficacy Study of ZW25 (Zanidatamab) Plus Combination Chemotherapy in HER2-expressing Gastrointestinal Cancers, Including Gastroesophageal Adenocarcinoma, Biliary Tract Cancer, and Colorectal Cancer
CompletedNCT03929666
Jazz PharmaceuticalsHER2-expressing Gastrointestinal Cancers, Including Gastroesophageal Adenocarcinoma, Biliary Tract Cancer, and Colorectal Cancer
Start: 2019-08-29End: 2025-08-30Updated: 2025-09-12
A Study of ZW25 (Zanidatamab) With Palbociclib Plus Fulvestrant in Patients With HER2+/HR+ Advanced Breast Cancer
CompletedNCT04224272
Jazz PharmaceuticalsHER2+/HR+ Breast Cancer
Start: 2020-06-10End: 2025-06-30Updated: 2025-08-01
A Study of ZW25 (Zanidatamab) in Subjects With Advanced or Metastatic HER2-Amplified Biliary Tract Cancers
CompletedNCT04466891
Jazz PharmaceuticalsHER2-amplified Biliary Tract Cancers
Start: 2020-10-01End: 2024-07-11Updated: 2025-09-15

Related Papers

Data from Zanidatamab, a Dual HER2-Targeted Bispecific Antibody, in Patients with Unresectable Locally Advanced or Metastatic HER2-Positive Salivary Gland Cancer: A Combined Analysis of Early-Phase Studies
2026-06-19
Molecular circulating tumor DNA (ctDNA) profiling from patients (pts) treated with zanidatamab + chemotherapy (CT) in first-line (1L) HER2-positive (HER2+) advanced or metastatic gastroesophageal adenocarcinoma (mGEA).
Journal of Clinical Oncology2026-05-27
Zanidatamab, a Dual HER2-Targeted Bispecific Antibody, in Patients With Unresectable Locally Advanced or Metastatic HER2-Positive Salivary Gland Cancer: A Combined Analysis of Early-Phase Studies.
2026-03-23
Landmark analysis of overall survival (OS) by objective response in patients (pts) with previously treated, advanced HER2-positive biliary tract cancer (BTC): Post hoc analysis of the HERIZON-BTC-01 trial.
Journal of Clinical Oncology2026-01-10
Zanidatamab plus chemotherapy as first-line treatment for patients with HER2-positive advanced gastro-oesophageal adenocarcinoma: primary results of a multicentre, single-arm, phase 2 study.
2025-06-025 citations
Long-term outcomes and overall survival (OS) for zanidatamab + chemotherapy in HER2-positive (HER2+) advanced or metastatic gastroesophageal adenocarcinoma (mGEA): 4-year follow-up of a phase 2 trial.
Journal of Clinical Oncology2025-05-281 citations
Concordance analysis between tumor tissue HER2 status by immunohistochemistry (IHC) and in situ hybridization (ISH) and a translational analysis of plasma ctDNA in patients (pts) with biliary tract cancer (BTC): An exploratory analysis from the phase 2 HERIZON-BTC-01 trial.
Journal of Clinical Oncology2025-05-281 citations
Survival outcomes for zanidatamab-hrii compared to chemotherapy in previously treated HER2-positive (IHC3+) biliary tract cancer (BTC): HERIZON-BTC-01 vs a real-world (RW) external control arm (ECA).
Journal of Clinical Oncology2025-05-28
Zanidatamab monotherapy or combined with chemotherapy in HER2-expressing gastroesophageal adenocarcinoma: a phase 1 trial
Nature Communications2025-05-085 citations
Zanidatamab plus palbociclib and fulvestrant in previously treated patients with hormone receptor-positive, HER2-positive metastatic breast cancer: primary results from a two-part, multicentre, single-arm, phase 2a study.
2025-05-055 citations
Zanidatamab dose optimization in patients with HER2-positive biliary tract cancer (BTC).
Journal of Clinical Oncology2025-01-27
A plain language summary of the results from the phase 2b HERIZON-BTC-01 study of zanidatamab in participants with HER2-amplified biliary tract cancer
Future Oncology2024-08-083 citations
Zanidatamab in previously-treated HER2-positive (HER2+) biliary tract cancer (BTC): Overall survival (OS) and longer follow-up from the phase 2b HERIZON-BTC-01 study.
Journal of Clinical Oncology2024-06-0118 citations
Abstract LBO1-04: Primary results from a phase 2a study of zanidatamab (zani) + palbociclib (palbo) + fulvestrant (fulv) in HER2+/HR+ metastatic breast cancer (mBC)
Cancer Research2024-05-024 citations
Co-clinical Trial of Novel Bispecific Anti-HER2 Antibody Zanidatamab in Patient-Derived Xenografts
Cancer Discovery2024-02-1421 citations
Zanidatamab (zani) in previously treated HER2+ biliary tract cancer (BTC): Impact on patient-reported pain outcomes in the phase 2b HERIZON-BTC-01 study.
Journal of Clinical Oncology2024-01-20
Abstract B126: Co-clinical trial of novel bispecific anti-HER2 antibody Zanidatamab in Patient-Derived Xenografts
Molecular Cancer Therapeutics2023-12-01
Zanidatamab for HER2-amplified, unresectable, locally advanced or metastatic biliary tract cancer (HERIZON-BTC-01): a multicentre, single-arm, phase 2b study.
2023-06-02139 citations
Results from the pivotal phase (Ph) 2b HERIZON-BTC-01 study: Zanidatamab in previously-treated HER2-amplified biliary tract cancer (BTC).
Journal of Clinical Oncology2023-06-019 citations
Abstract CT278: <i>ERBB2</i> amplification detected in ctDNA as a surrogate for tumor tissue FISH analysis of HER2 status in a phase 1 study with zanidatamab for the treatment of locally advanced or metastatic HER2 expressing cancers
Cancer Research2023-04-14

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