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

United States

Additional Institutions

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/ Texas Oncology - DFW Dallas, TX 75246 Minnesota Oncology Hematology, P.A. Maple Grove, MN 55369 Rocky Mountain Cancer Centers, LLP Lone Tree, CO 80124 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/ Memorial Sloan Kettering Cancer Center 160 East 53rd Street New York, NY 10022 Telephone: 332-895-1897 Website: mskcc.org

Additional Principal Investigators

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 Michael Driscoll, MD Telephone: 502-636-7845 GI-NCIResearch@nortonhealthcare.org James Harding, MD Telephone:  332-895-1897 https://www.mskcc.org/cancer-care/doctors/james-harding

Study Coordinator

Multiple Study Coordinators (see below)

Additional Study Coordinators

Isamar Alicea Telephone: 787-407-3333 https://panoncologytrials.com/2) Referral Line Telephone: 844-482-4812 Connect With Us | Sarah Cannon. Research Telephone: 502-636-7845 GI-NCIResearch@nortonhealthcare.org

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

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

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 Study

HER2 diagnostic test, which will be determined by your health care team

Potential Side Effects

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 Available

Yes

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