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) | |
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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 |
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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; [email protected] ) 2. Howard Burris (Ph: (615) 329-7274; [email protected] ) 3. Geoffrey Ku (Ph: (646) 888-4184; [email protected] ) 4. Syma Iqbal (Ph: (323) 865-3967; [email protected]) 5. Jaffer Ajani (Ph: (713) 792-2828; [email protected] ) 6. Sreenivasa Chandana (Ph: (269) 993-6056; [email protected] ) 7. Joel Michalski (Ph: (402) 354-5831; [email protected] ) Canada and Republic of Korea: please see https://clinicaltrials.gov/ct2/show/NCT03929666 |
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Study Coordinator | |
Multiple Study Coordinators (see below) | |
List additional Study Coordinators (include phone number and email) | |
USA: 1. Erika Starkov (Ph: (215) 214-1588; [email protected] ) 2. Dillon O’Brien (Ph: (615) 598-5919; [email protected] ) 3. Ariel Antonie (Ph: (646) 888-4526; [email protected] ) 4. Victoria Amran (Ph: (323) 865-6922; [email protected] ), Ria Yambao-Ronquillo (Ph: (949) 764-6743; [email protected] ) 5. Jackie Smith (Ph: (713) 745-3917; [email protected] ) 6. Shannon Fabrie (Ph: (616) 954-5550; [email protected] ) 7. Mary Beth Wilwerding (Ph: (402) 354-5831; [email protected] ) Canada and Republic of Korea: please see Principal Investigators’ contact information at: https://clinicaltrials.gov/ct2/show/NCT03929666 |
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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) | |
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Inclusion Criteria – Patients Must: | |
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Exclusion Criteria – Patients Must NOT: | |
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REQUIRED TESTS PRIOR TO BEGINNING STUDY TREATMENT – in layman’s terms | |
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POTENTIAL SIDE-EFFECTS – in layman’s terms | |
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