RealiZe Study
Research type
Research Study
Full title
Multinational Real World Study of Patients with HER2-positive Biliary Tract Cancer Treated with Zanidatamab in an Early Access Program – RealiZe Study
IRAS ID
364497
Contact name
John Bridgewater
Contact email
Sponsor organisation
Jazz Pharmaceuticals
Clinicaltrials.gov Identifier
70928, CPMS ID
Duration of Study in the UK
0 years, 6 months, 1 days
Research summary
Biliary tract cancer (BTC) is a rare but aggressive cancer affecting the gallbladder and bile ducts. It accounts for around 1 in every 100 adult cancers. Many patients are diagnosed too late for surgery, and even those who do have surgery often have the cancer return. For people with advanced BTC, survival rates are very low, and new treatment options are urgently needed.
Zanidatamab is an experimental medicine that has shown promise in clinical trials for BTC. Before full approval, some patients in the UK, Spain and Italy were able to access zanidatamab through an Early Access Program (EAP). These programs allow patients with serious conditions to receive potentially beneficial treatments before they are widely available.
This research project, called the RealiZe study, will use medical record data from UK patients who received zanidatamab through the EAP. The aim is to better understand how the medicine works in real-world practice. Specifically, the study will:
- Describe the characteristics and medical history of patients treated with zanidatamab
- Examine how zanidatamab was used in practice
- Evaluate how effective zanidatamab was for patients with previously treated, advanced or metastatic HER2-positive BTC.
The study will use existing medical records only, focused on when participants were taking the medicine. It is retrospective, and no extra visits or tests are required, patient care will not be affected. It is observational, meaning it will not change how patients are treated. The findings will help doctors and researchers understand the potential benefits of zanidatamab in the real world (i.e. outside of clinical trials).
The study is sponsored and funded by Jazz Pharmaceuticals and, in the UK, will take place at the NHS hospital that participated in the EAP.REC name
HSC REC B
REC reference
26/NI/0041
Date of REC Opinion
23 Mar 2026
REC opinion
Further Information Favourable Opinion