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 [email protected] 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; [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
Chile: please contact Zymeworks Clinical Trial Resource at [email protected] 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; [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
Chile: please contact Zymeworks Clinical Trial Resource at [email protected] 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