An open-label randomized trial of zanidatamab for advanced HER2-positive biliary tract cancer

• Research type

  Research Study

• Full title

  An open-label randomized trial of the efficacy and safety of zanidatamab with standard-of-care therapy against standard-of-care therapy alone for advanced HER2-positive biliary tract cancer.

• IRAS ID

  1009487

• Contact name

  Kieran ODonoghue

• Contact email

  Kieran.ODonoghue@jazzpharma.com

• Sponsor organisation

  Jazz Pharmaceuticals Ireland Limited

• Eudract number

  2023-508219-21

• Research summary

  This is an open-label, randomized, multicenter, phase 3 study to investigate the efficacy and safety of zanidatamab plus CisGem with or without a PD-1/L1 inhibitor (physician’s choice of either durvalumab or pembrolizumab, where approved under local regulations) as first-line treatment for participants with HER2-positive, locally advanced unresectable or metastatic BTC, including gallbladder cancer (GBC), intrahepatic cholangiocarcinoma (ICC), and extrahepatic cholangiocarcinoma (ECC).
  The purpose of this study is to find out whether zanidatamab combined with standard-of-care is safe and works in treating HER2-positive, locally advanced unresectable or metastatic BTC. We also want to find out if zanidatamab may shrink tumours for the type of cancer.
  HER2 is short for human epidermal growth factor receptor 2. HER2 is a gene. Some cancers have extra copies of HER2. This can cause the cancer cells to grow and form a tumour. This is known as HER2-expressing cancer. Biliary tract cancer is a type of cancer that affects the bile duct system, which includes the liver and gallbladder.
  Zanidatamab is a type of drug called a monoclonal antibody. Antibodies are proteins that the body makes to attack things that could be harmful, like viruses and bacteria. A monoclonal antibody is an antibody made in a lab that is designed to attack only one substance. Monoclonal antibodies are used to treat certain types of cancer. Zanidatamab is an antibody drug that attacks HER2.
  Participants are allowed to receive up to 2 cycles of systemic therapy consisting of gemcitabine with a platinum agent (eg, CisGem or gemcitabine in combination with oxaliplatin [GEMOX]) with or without a PD-1/L1 inhibitor prior to randomisation for their advanced or metastatic disease.
  disease. Note that Cycle 1 Day 1 (C1D1) is defined as the day of first dose after randomization regardless of whether
  a participant receive

• REC name

  North of Scotland Research Ethics Committee 1

• REC reference

  24/NS/0086

• Date of REC Opinion

  29 Aug 2024

• REC opinion

  Further Information Favourable Opinion