Herizon BTC-302 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
| ClinicalTrials.gov Identifier |
| NCT06282575 |
| Institution Name |
| Multiple Sites (see below) |
| Full Institution Address |
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United States |
| Additional Institutions |
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California Locations Florida Locations Orlando, Florida, United States, 32804 AdventHealth Orlando Georgia Locations Atlanta, Georgia, United States, 30322 Winship Cancer Institute Dr. Olumide Gbolahan Telephone: 404-251-1278 kmcole5@emory.edu Kentucky Locations Louisville, Kentucky, United States, 40217 Norton Cancer Institute - Audubon 2355 Poplar Level Rd, Suite 405 Louisville, KY 40217 Telephone: 502-636-7845 https://nortonhealthcare.com/services-and-conditions/cancer-care/ Louisiana Locations New Orleans, Louisiana, United States, 70121 Ochsner Clinic Foundation Michigan Locations Ann Arbor, Michigan, United States, 48109 University of Michigan Hospital Dr. Vaibhav Sahai Telephone: 800-865-1125 CancerAnswerline@med.umich.edu Detroit, Michigan, United States, 48202 Henry Ford Health System Dr. Maria Diab Telephone: 1-888-734-5322 https://www.henryford.com/ New York Locations New York, New York, United States, 10016 Laura and Isaac Perlmutter Cancer Center at NYU Langone - Ambulatory Care Center Dr. Kristen Spencer Telephone: 212-731-6000 New York, New York, United States, 10022 Memorial Sloan Kettering Cancer Centers 160 East 53rd Street New York, NY 10022 James Harding, MD Telephone: 646-888-4314 https://www.mskcc.org/cancer-care/doctors/james-harding Oregon Locations Oregon Health and Science University Portland, Oregon 97239 Dr. Emerson Chen 503-494-1080 trials@ohsu.edu South Carolina Locations Greenville, South Carolina, United States, 29607 Saint Francis Cancer Center Dr. Xuezhong Yang Telephone: 864-603-6234 Heather_rich@bshsi.org or Ashley_Coates@bshsi.org Texas Locations Dallas, Texas, United States, 75390 University of Texas Southwestern Medical Center Houston, Texas, United States, 77030 The University of Texas MD Anderson Cancer Center Dr. Shubham Pant GIClinicalTrials@mdanderson.org Virginia Locations Richmond, Virginia, 23219 Virginia Commonwealth University, VCU Health Dr. Emily Kinsey 804-628-6430 masseygi@vcu.edu Puerto Rico Locations Hospital Oncologico, Puerto Rico Medical Center Second Floor, Barrio Monacillos Rio Piedras, Puerto Rico, USA 00935 Telephone: 787-407-3333 Website: https://panoncologytrials.com |
| Study Overview |
| To test the effectiveness & safety of Zanidatamab (JZP598) with standard of care against standard of care alone as a first line treatment for Biliary Tract Cancer (including ICC, ECC, and gallbladder cancer) that contain extra HER2 protein on cancer cells. Patients must have HER2, advanced (unresectable) or metastatic biliary tract cancer. |
| Enrollment Information |
| 286 patients |
| Study Start Date |
| 20240209 |
| Study End Date |
| 20291101 |
| Study Purpose |
| The purpose of this study is to evaluate the efficacy and safety of Zanidatamab plus CisGem (Cisplatin and Gemcitabine) with or without the addition of a programmed death protein 1/ligand-1 (PD-1/L1) inhibitor (physician's choice of either Durvalumab or Pembrolizumab, where approved under local regulations) as first line of treatment for participants with human epidermal growth factor receptor 2 (HER2)-positive biliary tract cancer. |
| Inclusion Criteria |
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| Exclusion Criteria |
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| Required Tests Prior to Study |
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| Potential Side Effects |
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| Financial Assistance Available |
| Yes |