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

Study Name
	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 (if applicable)
	NCT03929666
Clinical Trial Category (check all that apply)
	First Line Therapy Chemotherapy Targeted Therapy Immunotherapy
Study Center
Institution Name
	Multiple Sites (see below)
Country
	United States
List additional Institutions (include address, phone number, and website)
	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
Study Contacts
Principal Investigator
	Multiple Principal Investigators (see below)
List additional Principal Investigators (include phone number and email)
	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)
List additional Study Coordinators (include phone number and email)
	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
OVERVIEW – in layman’s terms (150 words max)
	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
	362 patients total, a portion of which will be patients with biliary tract cancer
Study Start Date
	08/29/2019
Estimated Completion Date
	04/30/2024
Purpose of the Study – in Layman’s Terms (use the “+” to add more list items)
	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 – Patients Must:
	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 – Patients Must NOT:
	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 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 (similar to an allergy) related to the infusion Mild or moderate (managed at home) diarrhea