Phase I study of ZW25 (bispecific antibody) in patients with advanced HER2-expressing cancers

Study Name
Phase I study of ZW25 (bispecific antibody) in patients with advanced HER2-expressing cancers
ClinicalTrials.gov Identifier (if applicable)
NCT02892123
Clinical Trial Category (check all that apply)
  • Beyond First Line Therapy
  • Targeted Therapy
Study Center
Institution Name
MD Anderson
Institution Address
Investigational Cancer Therapeutics
City
Houston
State
Texas
Zip Code
77030
List additional Institutions (include address, phone number, and website)
Sarah Cannon. Nashville, TN
START, SanAntonio, TX
University of Colorado, Denver, CO
USC/Norris cancer center, Los Angeles, CA
North West Medical Specialist, Tacoma, WA
Study Contacts
Principal Investigator
Dr. Meric Bernstam
P.I. Phone
(713) 794-1226
P.I. Email
fmeric@mdanderson.org
List additional Principal Investigators (include phone number and email)
Dr. Erika Hamilton
Dr. Murali Beeram
Dr. Jose Mayordomo
Dr. Diana Hanna
Dr. Chaves
Study Coordinator
Kavitha Balaji
Study Coordinator Phone
(713) 745-7559
Study Coordinator Email
kbalaji@mdanderson.org
List additional Study Coordinators (include phone number and email)
START: isabel.jimenez@startsa.com210-593-5261
North West Medical Specialist: idhaene@nwsonline.com253-428-8753
OVERVIEW – in layman’s terms (150 words max)
ZWI-ZW25-101 is a clinical study of ZW25 as a treatment for advanced (unresectable) and/or metastatic HER2-expressing cancers, including cholangiocarcinoma. Patients will receive once a week or once every other two weeks by IV infusion and will be monitored for safety and to determine response to the drug.
Enrollment
up to 99 patients
Study Start Date
09/14/2016
Estimated Completion Date
12/29/2018
Purpose of the Study – in Layman’s Terms (use the “+” to add more list items)
  • To investigate the safety and efficacy of ZW25
Inclusion Criteria – Patients Must:
  • Locally advanced (unresectable) and/or metastatic HER2-expressing cancers that have progressed after receiving all therapies known to have clinical benefit
  • 18 years of age or older
  • Willing to undergo a tumor biopsy, unless it is considered unsafe to do so
  • Adequate liver and kidney function
  • Adequate hematologic function
  • Adequate cardiac left ventricular function
Exclusion Criteria – Patients Must NOT:
  • Prior to first dose of ZW25: Received trastuzumab, pertuzumab, lapatinib, or T DM1 within 3 weeks; Received another cancer therapy (including chemotherapy, small molecules, and antibodies) within 5 half-lives of that cancer therapy; Received experimental therapies within 4 weeks
  • Untreated brain metastases; stable, treated stable brain metastases are allowed
  • Pregnant or breast-feeding
  • History of life-threatening hypersensitivity to monoclonal antibodies
  • Clinically significant cardiac disease, including known myocardial infarction or unstable angina within 6 months prior to first dose of ZW25
REQUIRED TESTS PRIOR TO BEGINNING STUDY TREATMENT – in layman’s terms
  • HER2 test
POTENTIAL SIDE-EFFECTS – in layman’s terms
  • This is first in human trial.
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