A Dose Finding Study of ZW49 in Patients With HER2-Positive Cancers
NCT ID: NCT03821233
Last Updated: 2025-01-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
112 participants
INTERVENTIONAL
2019-04-15
2024-10-08
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
PARALLEL
TREATMENT
NONE
Study Groups
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ZW49
ZW49
* Dose Escalation: ZW49 administered intravenously at dose levels determined by the SMC
* Expansion: MTD or RD identified in the dose-escalation part of the study
Interventions
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ZW49
* Dose Escalation: ZW49 administered intravenously at dose levels determined by the SMC
* Expansion: MTD or RD identified in the dose-escalation part of the study
Eligibility Criteria
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Inclusion Criteria
* Dose-escalation (Cohort 1): HER2-high advanced solid tumors
* Expansion (Cohort 2): HER2-high breast cancer
* Expansion (Cohort 3): HER2-high GEA
* Expansion (Cohort 4): HER2-high other non-breast and non-GEA cancers
* Progressive disease that has progressed on or been refractory to all standard of care. Patients who were intolerant to or ineligible for standard therapy may be eligible if the reasons are carefully documented and approval is provided by the sponsor medical monitor
* Patients with HER2-high breast cancer must have received prior treatment with trastuzumab, pertuzumab, and ado-trastuzumab emtansine (T-DM1)
* Patients with HER2-high GEA must have received prior treatment with trastuzumab
* Sites of disease assessible per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
* Dose-escalation: measurable or non-measurable disease
* Expansion: measurable disease
* ECOG performance status score of 0 or 1
* Adequate organ function
* Adequate cardiac left ventricular function, as defined by a LVEF \>/= institutional standard of normal
Exclusion Criteria
* Clinically significant infiltrative pulmonary disease not related to lung metastases
* Active hepatitis B or hepatitis C infection or other known chronic liver disease
* Acute or chronic uncontrolled renal disease, pancreatitis, or liver disease (with exception of patients with Gilbert's Syndrome, asymptomatic gall stones, liver metastases, or stable chronic liver disease per investigator assessment)
* Known history of human immunodeficiency virus (HIV) infection
* Brain metastases: Untreated CNS metastases, symptomatic CNS metastases, or radiation treatment for CNS metastases within 4 weeks of start of study treatment. Stable, treated brain metastases are allowed (defined as patients who are off steroids and anticonvulsants and are stable for at least 1 month at the time of screening).
* Known leptomeningeal disease (LMD)
18 Years
ALL
No
Sponsors
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Zymeworks BC Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Joseph Woolery, PharmD, BCOP
Role: STUDY_DIRECTOR
Zymeworks BC Inc.
Locations
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City of Hope
Duarte, California, United States
Moffitt Cancer Center
Tampa, Florida, United States
University of Chicago Medicine
Chicago, Illinois, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
NEXT Oncology
San Antonio, Texas, United States
Virginia Cancer Specialists, PC
Fairfax, Virginia, United States
Flinders Medical Centre
Adelaide, , Australia
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Jewish General Hospital
Montreal, Quebec, Canada
Seoul National University Bundang Hospital
Seongnam-si, , South Korea
Korea University Anam Hospital
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Countries
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Other Identifiers
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ZWI-ZW49-101
Identifier Type: -
Identifier Source: org_study_id