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

Study Name
	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 (if applicable)
	NCT06282575
Clinical Trial Category (check all that apply)
	First Line Therapy Chemotherapy Targeted Therapy Immunotherapy
Study Center
Institution Name
	Multiple Sites (see below)
State
	– Please Select –
Country
	United States
List additional Institutions (include address, phone number, and website)
	1) Hospital Oncologico, Puerto Rico Medical Center Second Floor, Barrio Monacillos Rio Piedras, Puerto Rico, USA 00935 Telephone: 787-407-3333 Website: https://panoncologytrials.com/2) SCRI Oncology Partners 335 24th Avenue North, Suite 200 Nashville, TN USA 37203 Telephone: 844-482-4812 Website: https://sarahcannon.com/ 3) Texas Oncology – DFW Dallas, TX 75246 4) Minnesota Oncology Hematology, P.A. Maple Grove, MN 55369 5) Rocky Mountain Cancer Centers, LLP Lone Tree, CO 80124 6) Norton Cancer Institute – Audubon Hospital Campus Medical Plaza West 2355 Poplar Level Rd, Suite 405 Louisville, KY 40217 Telephone: 502-636-7845 https://nortonhealthcare.com/services-and-conditions/cancer-care/ 7) Memorial Sloan Kettering Cancer Center 160 East 53rd Street New York, NY 10022 Telephone: 332-895-1897 Website: mskcc.org
Study Contacts
List additional Principal Investigators (include phone number and email)
	1) Karina Arocho-Gonzalez, MD Telephone: 787-407-3333 https://panoncologytrials.com/2) Meredith Sellers Pelster, MD Telephone: 844-482-4812 Connect With Us \| Sarah Cannon 6) Michael Driscoll, MD Telephone: 502-636-7845 GI-NCIResearch@nortonhealthcare.org 7) James Harding, MD Telephone: 332-895-1897 https://www.mskcc.org/cancer-care/doctors/james-harding
Study Coordinator
	Multiple Study Coordinators (see below)
List additional Study Coordinators (include phone number and email)
	1) Isamar Alicea Telephone: 787-407-3333 https://panoncologytrials.com/2) Referral Line Telephone: 844-482-4812 Connect With Us \| Sarah Cannon. 6) Research Telephone: 502-636-7845 GI-NCIResearch@nortonhealthcare.org
OVERVIEW – in layman’s terms (150 words max)
	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
	286 patients
Study Start Date
	02/09/2024
Estimated Completion Date
	11/01/2029
Purpose of the Study – in Layman’s Terms (use the “+” to add more list items)
	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 – Patients Must:
	Have diagnosed Biliary Tract Cancer (BTC) (Gallbladder Cancer (GBC), Intrahepatic Cholangiocarcinoma (ICC), or Extrahepatic Cholangiocarcinoma (ECC)). Locally advanced unresectable or metastatic BTC and not eligible for curative resection, transplantation, or ablative therapies. Received no more than 2 cycles of systemic therapy with gemcitabine and a platinum agent with or without your physician’s choice of durvalumab or pembrolizumab, where approved under local regulations for advanced unresectable or metastatic disease. HER2-positive disease (defined as IHC 3+; or IHC 2+/ ISH+) a central laboratory on new or archival tissue. Radiographically assessable (by CT scan or MRI) Male or female ≥ 18 years Adequate organ function Females of childbearing potential must have a negative pregnancy test result. Females of childbearing potential and males with a partner of childbearing potential must be willing to use 2 methods of birth control.
Exclusion Criteria – Patients Must NOT:
	Prior treatment with a HER2-targeted agent Prior treatment with checkpoint inhibitors (other than the durvalumab or pembrolizumab as described in inclusion criterion 3) The following cancer subtypes are excluded: small cell cancer, neuroendocrine tumors, lymphoma, sarcoma, mixed tumor histology, and mucinous cystic neoplasms detected in the biliary tract region Use of systemic corticosteroids Brain metastases Severe chronic or active infections History of allogeneic organ transplantation Active or prior autoimmune inflammatory conditions History of interstitial lung disease or non-infectious pneumonitis Participation in another clinical trial with an investigational medicinal product within the last 3 months Females who are breastfeeding Any other medical, social, or psychosocial factors that, in the opinion of the investigator, could impact safety or compliance with study procedures
REQUIRED TESTS PRIOR TO BEGINNING STUDY TREATMENT – in layman’s terms
	HER2 diagnostic test, which will be determined by your health care team
POTENTIAL SIDE-EFFECTS – in layman’s terms
	Mild or moderate reactions related to the infusion Mild or moderate (usually managed at home) diarrhea Mild or moderate (usually managed at home) nausea Altered blood counts
Financial Assistance is available to participants for travel, lodging, etc.
	Yes

If you would like to learn more about this study, please visit https://biliarytractcancerstudy.com