ZW25-201: A Phase 2 Study of Zanidatamab (ZW25; bispecific antibody) Plus First-line Chemotherapy in HER2-Expressing Cancers, Including Cholangiocarcinoma (Bile Duct Cancer), Gallbladder Cancer, and Colorectal Cancer

ClinicalTrials.gov Identifier

NCT03929666

Institution Name

Multiple Sites (see below)

Full Institution Address

United States

Additional Institutions

USA: 1. Fox Chase Cancer Center (333 Cottman Avenue, Philadelphia, PA USA) 2. Sarah Cannon Research Institute (250 25th Avenue North, Nashville, TN, USA) 3. Memorial Sloan Kettering Cancer Center (1275 York Avenue (New York, NY, USA) 4. University of Southern California Norris/Hoag (1441 Eastlake Avenue, Los Angeles, CA, USA) 5. MD Anderson Cancer Center (1515 Holcombe Boulevard, Houston, TX, USA) 6. Cancer & Hematology Centers of Western Michigan (145 Michigan Street Northeast, Grand Rapids, MI, USA) 7. Nebraska Methodist Hospital (8303 Dodge St #LL04, Omaha, NE, USA) Canada and Republic of Korea: please see https://clinicaltrials.gov/ct2/show/NCT03929666 Chile: please contact Zymeworks Clinical Trial Resource at medinfo@zymeworks.com or (206) 237-1030

Principal Investigator

Multiple Principal Investigators (see below)

Additional Principal Investigators

USA: 1. Namrata Vijayvergia (Ph: (215) 214-1676; Namrata.Vijayvergia@fccc.edu ) 2. Howard Burris (Ph: (615) 329-7274; howard.burris@scresearch.net ) 3. Geoffrey Ku (Ph: (646) 888-4184; kug@mskcc.org ) 4. Syma Iqbal (Ph: (323) 865-3967; iqbal_s@med.usc.edu) 5. Jaffer Ajani (Ph: (713) 792-2828; jajani@mdanderson.org ) 6. Sreenivasa Chandana (Ph: (269) 993-6056; schandana@chcwm.com ) 7. Joel Michalski (Ph: (402) 354-5831; joel.michalski@nmhs.org ) Canada and Republic of Korea: please see https://clinicaltrials.gov/ct2/show/NCT03929666 Chile: please contact Zymeworks Clinical Trial Resource at medinfo@zymeworks.com or (206) 237-1030

Study Coordinator

Multiple Study Coordinators (see below)

Additional Study Coordinators

USA: 1. Erika Starkov (Ph: (215) 214-1588; Erika.Davis@fccc.edu ) 2. Dillon O'Brien (Ph: (615) 598-5919; dillon.obrien@sarahcannon.com ) 3. Ariel Antonie (Ph: (646) 888-4526; antoinea@mskcc.org ) 4. Victoria Amran (Ph: (323) 865-6922; victoria.Amran@med.usc.edu ), Ria Yambao-Ronquillo (Ph: (949) 764-6743; Ria.YambaoRonquillo@hoag.org ) 5. Jackie Smith (Ph: (713) 745-3917; jsmith19@mdanderson.org ) 6. Shannon Fabrie (Ph: (616) 954-5550; sfabrie@chcwm.com ) 7. Mary Beth Wilwerding (Ph: (402) 354-5831; MaryBeth.Wilwerding@nmhs.org ) Canada and Republic of Korea: please see Principal Investigators' contact information at: https://clinicaltrials.gov/ct2/show/NCT03929666 Chile: please contact Zymeworks Clinical Trial Resource at medinfo@zymeworks.com or (206) 237-1030

Study Overview

This study will test the effectiveness & safety of zanidatamab in combination with standard first-line chemotherapy for the treatment of cancers that express a protein called HER2 or contain extra copies of the HER2 gene. Included in this study are patients with cholangiocarcinoma (bile duct cancer), gallbladder cancer, and colorectal cancer.

Enrollment Information

362 patients total, a portion of which will be patients with biliary tract cancer

Study Start Date

20190829

Study End Date

20240430

Study Purpose

To investigate the efficacy and safety of zanidatamab in combination with standard first line chemotherapy in HER2-expressing cancers, including cholangiocarcinoma (bile duct cancer), gallbladder cancer, and colorectal cancer.

Inclusion Criteria

Have a disease diagnosis of Biliary Tract Cancer (including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, or gallbladder cancer) that has a high expression of the HER2 protein or has extra copies of the HER2 gene, and that cannot be cured by surgery or that has spread to other parts of the body Have an Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1 Have normal organ function Have normal heart function

Exclusion Criteria

Have had prior treatment with a HER2-targeted agent Have had prior cancer therapy within 6 months of treatment in this study, except for less than one month of therapy for advanced disease Have untreated cancer that has spread to the brain Have active HIV or viral hepatitis Have had a heart attack or unstable angina within 6 months, or have significant heart disease Be pregnant or breast-feeding

Required Tests Prior to Study

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

Potential Side Effects

Mild or moderate reactions (similar to an allergy) related to the infusion Mild or moderate (managed at home) diarrhea

Financial Assistance Available

No

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